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| Name | Class |
|---|---|
| University of Florida | OTHER |
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There is a surgical procedure to help children with intractable fecal incontinence gain continence for stool through construction of a tube that connects the abdominal wall to the colon near or through the appendix. This tube allows easy administration of enema solution into the first part of the colon. Putting enema solution through that tube into the colon is called an antegrade continence enema (ACE) and has been shown to work well in helping some but not all children prevent stool accidents. The purpose of this study is to compare a large volume ACE flush using a salt water solution called normal saline with a small volume ACE flush using liquid glycerin. The aims of this study are to: 1) find the most effective dose and flush frequency of each solution needed to prevent stool accidents; 2) compare which solution given at the best dose has the least side effects and 3) to determine if administration of either of the ACE flushing solutions causes electrolyte abnormalities or affects colon health.
Fecal incontinence past the time of toilet training is devastating to affected children. Antegrade continence enema (ACE) therapy administered through a catheterizable stoma surgically placed in the cecum has helped children with intractable fecal incontinence attain continence for stool. There are a number of retrospective studies demonstrating the variable effectiveness rates of ACE therapy. This variability may be due to what is used to flush. There are no prospective trials evaluating the effectiveness of different flushing regimens. The catheterizable stoma used for the antegrade administration of enema solution is frequently made by bringing the appendix out through the abdominal wall or by placing a skin-level device (button) in to the cecum. ACE therapy administration through the appendix or into the cecum has the potential to cause colonic dysfunction. The effects of ACE administration on colonic mucosal health has not been investigated. This pilot study will compare a high volume normal saline (NS) flush and a low volume United States Pharmacopeia (USP) glycerin flush. The primary aims of the study are to compare which solution, given at an optimal dose and frequency, is associated with fewer side effects, while promoting the higher degree of fecal continence, and to determine if antegrade enema solution administration through an appendicostomy/cecostomy causes electrolyte abnormalities or affects gut health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-operative Baseline Phase | No Intervention | Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control. | |
| Dose Response - NS and USP Glycerin - First Intervention | Experimental | Initial flush used NS or USP Glycerin randomized to treatment sequence. The starting volume and administration frequency for NS was 10mL/kg and glycerin 20 mL administered every other day. The NS dose was titrated in 10 mL increments to achieve continence so as not to exceed 500 mL daily for a child under five years of age and 1000 mL daily for a child over 5 years of age. USP Glycerin was titrated in 5 mL increments so as not to exceed 50 mL daily. For side effects greater than Wong Bailey Faces Pain Rating Scale (WBFPRS) level 4, NS was decreased by 2.5 mL/kg to the lowest dose of 5 mL/kg daily. USP Glycerin was decreased in 5 mL increments to the lowest dose of 5 mL daily. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was be trialed on the alternate therapy and then dropped from the study. |
|
| NS and USP Glycerin - Effectiveness - Second Intervention | Experimental | To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they achieved continence on optimal dosing with minimal side effects.This arm evaluated the long term effectiveness of NS and glycerin at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose Response - NS and USP Glycerin - First Intervention | Drug | This trial used a repeated measures, single subjects alternating treatments A-B-C-B'-C'-B1' withdrawal design in which all subjects were tested under all conditions and each subject acted as his or her own control. The subjects were randomly assigned to either normal saline or USP glycerin to control for order effects. Baseline data A served as the control and was obtained pre-operatively. The B-C arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration of NS and USP Glycerin necessary to promote fecal continence. When the optimal dose as identified, the child continued on that dose for 2 weeks to insure treatment stability and effectiveness. |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen | Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on the last data point in the final phase for both the NS and USP glycerin flush. | Data collection started following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days. |
| Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin | Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. Descriptive statistics included mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05, calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%). | Data collection began following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days. |
| Measure | Description | Time Frame |
|---|---|---|
| NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence | Flush administration frequency necessary to achieve continence was recorded as a single measure per subject per flush solution obtained as the number of flushes in the last three days of each dosing phase and recorded as either daily (1), every other day (2), or every third day (3). The larger the value, the less frequent the flush, the better the clinical outcome. Dosing frequency was measured using direct observational recording completed by the parent or child. Descriptive analysis included mean, and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly S Jarczyk, PhD | Nemours Children's Specialty Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Specialty Clinic | Jacksonville | Florida | 32207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11875145 | Background | Aksnes G, Diseth TH, Helseth A, Edwin B, Stange M, Aafos G, Emblem R. Appendicostomy for antegrade enema: effects on somatic and psychosocial functioning in children with myelomeningocele. Pediatrics. 2002 Mar;109(3):484-9. doi: 10.1542/peds.109.3.484. | |
| 12512028 | Background | Andersson RE, Olaison G, Tysk C, Ekbom A. Appendectomy is followed by increased risk of Crohn's disease. Gastroenterology. 2003 Jan;124(1):40-6. doi: 10.1053/gast.2003.50021. |
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9 assessed for eligibility, 4 excluded (3 did not meet inclusion criteria and 1 surgery date significantly delayed), 5 consented and randomized to treatment sequence in dosing phase (3 started on saline followed by USP Glycerin, 2 started on USP glycerin followed by saline).
Participants recruited from subspecialty clinics at Nemours Children's Clinic in Jacksonville, Florida between February 2016 and January of 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention: Pre-operative Baseline Phase | Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control. |
| FG001 | Post-Operative Dose Response: NS Then USP Glycerin | Subjects randomized to treatment sequence. Arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration for NS and USP glycerin necessary to meet outcome criteria. NS started at 10mL/kg administered every other day. Dose titrated to achieve continence so as not to exceed 500 mL NS daily for a child under five years of age, 1000 mL NS daily for a child over 5 years of age. Participant continued on effective dose for 2 weeks to insure treatment stability and effectiveness. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in episodes of fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was trialed on the alternate therapy and then dropped from the study. |
| FG002 | Post-Operative Dose Response: USP Glycerin Then NS | Subjects randomized to treatment sequence. Arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration for USP glycerin and necessary to meet outcome criteria. Glycerin started at 20 mL administered every other day. Dose titrated to achieve continence so as not to exceed 50 mL daily. Participant continued on effective dose for 2 weeks to insure treatment stability and effectiveness. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in episodes of fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was trialed on the alternate therapy and then dropped from the study. |
| FG003 | Effectiveness Phase: NS Then USP Glycerin | To prevent statistical bias from subject loss due to treatment failure, each child who successfully completed the dosing phase was randomized to a second treatment sequence once they have achieved continence on optimal dosing with minimal side effects. This arm evaluated the long term effectiveness of NS at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence. |
| FG004 | Effectiveness Phase: USP Glycerin Then NS | To prevent statistical bias from subject loss due to treatment failure, each child who successfully completed the dosing phase was randomized to a second treatment sequence once they have achieved continence on optimal dosing with minimal side effects. This arm evaluated the long term effectiveness of USP glycerin at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Preoperative Baseline Phase |
| |||||||||||||
| Dose Response - First Intervention |
| |||||||||||||
| Effectiveness - Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention: Pre-operative Baseline Phase | Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen | Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on the last data point in the final phase for both the NS and USP glycerin flush. | The data from a total of 5 participants were analyzed for each arm of the study. | Posted | Count of Participants | Participants | Data collection started following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days. |
|
1 year 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vagal Symptoms With NS Flush | Number of subjects experiencing vasovagal symptoms (symptom complex including pallor, diaphoresis, dizziness, weakness, nausea, with or without syncope) with antegrade administration of NS flush solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal Response | Vascular disorders | Non-systematic Assessment | Symptom complex reported by parent including pallor, diaphoresis, dizziness, weakness, nausea, with or without syncope |
Titration time to continence, procedural time, quality of life outcomes and microbiome sample analysis not reported due to limited number of subjects completing protocol. Study remained open without additional recruits until P.I. retirement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly S. Jarczyk, PhD, C-PNP | Nemours Children's Clinic | 9044611730 | jarczykks@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2019 | Aug 23, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D055496 | Neurogenic Bowel |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Effectiveness - NS and USP Glycerin - Second Intervention | Drug | To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they have achieved continence with minimal side effects on optimal dosing The second phase B'-C'-B1' of the study compared the two regimens at optimal dose and administration frequency. This phase was used to confirm the effectiveness of NS and USP Glycerin at optimal dosing on continence and assess side effects. |
|
|
| Frequency of administration data was collected as the total number of flushes recieved over the last three days of each dosing phase for both NS and USP Glycerin and recorded as either daily (1), every other day (2), or every third day |
| Flush Volume | Flush volume was measured in mL/flush using a graduated cylinder and recorded by the parent or child with each flush and later calculated in mL/kg. Data derived from the last flush of the completed dosing phase of both NS and USP Glycerin were used to calculate flush volume. Descriptive analysis included mean, median, range, and standard deviation. Reported data excludes subjects who failed to gain and maintain continence on either flushing regimen. | Data for analysis was collected from the last flush of the NS and USP Glycerin dosing phase of the study |
| Number of Participants With Any Electrolyte Abnormality | Evaluated impact of NS and USP Glycerin antegrade flush on serum electrolytes using a blood test called a Basic Metabolic Panel. Data analysis limited to percentage of subjects demonstrating any electrolyte abnormality on NS or USP glycerin. | Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples |
| Change in Stool Calprotectin Levels Assessed Through Comparing Levels Obtained Following Completion of NS and USP Glycerin Dosing Phases With the Baseline Value For Each Subject | Stool calprotectin was used to evaluate the impact of NS and USP Glycerin antegrade flush on colonic health. Calprotectin levels were obtained at baseline and following completion of the NS and USP Glycerin dosing phase of the study. Descriptive data analysis included mean and standard deviation for each flush regimen. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Both descriptive and inferential data analysis was calculated on the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush (value at completion of dosing phase - baseline value). The assumption was the length of each dosing phase was sufficient to achieve a credible active washout period and therefore levels obtained at the end of a phase reflected flushing regimen effects colonic health regardless of flush order. | Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples |
| Cramping With Flush | Cramping with flush was measured using the Wong Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS has undergone extensive testing and has well established psychometrics in the pediatric population. The scale ranges from 0 (very happy without pain) to 10 (the worse pain imaginable). Each pain level is associated with a facial expression. The child is asked to choose the face that best describes his/her level of discomfort (ordinal data). The parent was instructed to call if the child had flushing regimen-associated discomfort greater than a 4 on the WBFPRS. Documentation of pain severity was completed by the parent and child on a data-collection form at the time of occurrence. Descriptive statistics including mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the last data point in the dosing phase. | Data analysis was completed on data obtained during the last flush in both the NS and USP Glycerin dosing phase |
| Number of Participants Experiencing Vagal Symptoms With Flush | Vagal symptoms including nausea, vomiting, sweating, dizziness, and pallor were noted by the parent. The parent was instructed to call if the child had any vagal symptoms. Documentation of any vagal symptoms was completed by the parent and child on a data-collection form at the time of occurrence. Data was analyzed as a percentage of subjects experiencing vagal symptoms during flush with NS and USP glycerin. | Data collection started with the first flush administered following discharge from the hospital and was collected with every subsequent flush through completion of the study, an average of 115 days. |
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| Result | Jarczyk, K.S. (2017). A within subjects comparison of two antegrade flushing regimens in children. University of Florida, Gainesville, FL. UFE0051658 |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Cause of Neurogenic bowel | Number | participants |
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| Patulent anus | Number | participants |
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| Ambulatory | Number | participants |
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| Presence of Fecal Incontinence at Baseline | Count of Participants | Participants |
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Number of participants that gained and maintained continence on antegrade enema. |
| OG001 | Subjects Continent on USP Glycerin | Number of participants that gained and maintained continence on USP Glycerin antegrade enema. |
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| Primary | Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin | Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. Descriptive statistics included mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05, calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%). | The data from a total of 5 participants were analyzed for each arm of the study. | Posted | Mean | Standard Deviation | underwear soiled/day | Data collection began following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days. | Fecal Soiling | Fecal Soiling |
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| Secondary | NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence | Flush administration frequency necessary to achieve continence was recorded as a single measure per subject per flush solution obtained as the number of flushes in the last three days of each dosing phase and recorded as either daily (1), every other day (2), or every third day (3). The larger the value, the less frequent the flush, the better the clinical outcome. Dosing frequency was measured using direct observational recording completed by the parent or child. Descriptive analysis included mean, and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. | The data from a total of 5 participants were analyzed for each arm of the study. | Posted | Mean | Standard Deviation | Flush administration/day | Frequency of administration data was collected as the total number of flushes recieved over the last three days of each dosing phase for both NS and USP Glycerin and recorded as either daily (1), every other day (2), or every third day |
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| Secondary | Flush Volume | Flush volume was measured in mL/flush using a graduated cylinder and recorded by the parent or child with each flush and later calculated in mL/kg. Data derived from the last flush of the completed dosing phase of both NS and USP Glycerin were used to calculate flush volume. Descriptive analysis included mean, median, range, and standard deviation. Reported data excludes subjects who failed to gain and maintain continence on either flushing regimen. | Subjects limited to those who gained continence (2 saline, 4 USP Glycerin). One subject gained and maintained continence on saline in both the dosing and maintenance phases of the study and one subject who gained continence during the dosing phase of the study but failed to maintain continence on saline during the maintenance phase of the study. | Posted | Mean | Standard Deviation | mL/flush | Data for analysis was collected from the last flush of the NS and USP Glycerin dosing phase of the study |
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| Secondary | Number of Participants With Any Electrolyte Abnormality | Evaluated impact of NS and USP Glycerin antegrade flush on serum electrolytes using a blood test called a Basic Metabolic Panel. Data analysis limited to percentage of subjects demonstrating any electrolyte abnormality on NS or USP glycerin. | The data from a total of 5 participants were analyzed for each arm of the study. | Posted | Count of Participants | Participants | Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples |
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| Secondary | Change in Stool Calprotectin Levels Assessed Through Comparing Levels Obtained Following Completion of NS and USP Glycerin Dosing Phases With the Baseline Value For Each Subject | Stool calprotectin was used to evaluate the impact of NS and USP Glycerin antegrade flush on colonic health. Calprotectin levels were obtained at baseline and following completion of the NS and USP Glycerin dosing phase of the study. Descriptive data analysis included mean and standard deviation for each flush regimen. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Both descriptive and inferential data analysis was calculated on the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush (value at completion of dosing phase - baseline value). The assumption was the length of each dosing phase was sufficient to achieve a credible active washout period and therefore levels obtained at the end of a phase reflected flushing regimen effects colonic health regardless of flush order. | The data from a total of 5 participants were analyzed for NS and 4 participants for USP Glycerin | Posted | Mean | Standard Deviation | μg/g | Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples |
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| Secondary | Cramping With Flush | Cramping with flush was measured using the Wong Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS has undergone extensive testing and has well established psychometrics in the pediatric population. The scale ranges from 0 (very happy without pain) to 10 (the worse pain imaginable). Each pain level is associated with a facial expression. The child is asked to choose the face that best describes his/her level of discomfort (ordinal data). The parent was instructed to call if the child had flushing regimen-associated discomfort greater than a 4 on the WBFPRS. Documentation of pain severity was completed by the parent and child on a data-collection form at the time of occurrence. Descriptive statistics including mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the last data point in the dosing phase. | The data from a total of 5 participants were analyzed for each arm of the study. | Posted | Mean | Standard Deviation | units on a scale | Data analysis was completed on data obtained during the last flush in both the NS and USP Glycerin dosing phase |
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| Secondary | Number of Participants Experiencing Vagal Symptoms With Flush | Vagal symptoms including nausea, vomiting, sweating, dizziness, and pallor were noted by the parent. The parent was instructed to call if the child had any vagal symptoms. Documentation of any vagal symptoms was completed by the parent and child on a data-collection form at the time of occurrence. Data was analyzed as a percentage of subjects experiencing vagal symptoms during flush with NS and USP glycerin. | The data from a total of 5 participants were analyzed for each arm of the study. | Posted | Count of Participants | Participants | Data collection started with the first flush administered following discharge from the hospital and was collected with every subsequent flush through completion of the study, an average of 115 days. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Vagal Symptoms With USP Glycerin Flush | Number of subjects experiencing vasovagal symptoms (symptom complex including pallor, diaphoresis, dizziness, weakness, nausea, with or without syncope) with antegrade administration of USP Glycerin flush solution | 0 | 5 | 0 | 5 | 1 | 5 |
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Not provided
Not provided
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D017670 |
| Sodium Compounds |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |