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| Name | Class |
|---|---|
| University of Alberta | OTHER |
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IBS is a disorder of movement in the gut. People who have IBS may have diarrhea, constipation, or alternating bouts of both. IBS is not caused by injury or illness. Often the only way doctors can diagnose it is to rule out other conditions through testing.
Probiotics, particularly Bifidobacterium infantis, Sacchromyces boulardii, Lactobacillus plantarum and combination probiotics may help regulate how often people with IBS have bowel movements. Probiotics may also help relieve bloating from gas. Research is continuing to determine which probiotics are best to treat IBS.
PX0612
PX0612 is a probiotic which is composed of the following ingredients contained in a veggie capsule, being one dose:
Bacillus coagulans 200 million colony forming units 16.0mg Bacillus subtilis 100 million colony forming units 4.8mg Enterococcus faecium 100 million colony forming units 0.6mg Fructo-oligosacharride a nutrient for the packaged product 600.0mg Total 621.4 mg Bacillus coagulans is a non-pathogenic, Gram positive, spore forming bacteria that produces lactic acid. Though not normally found in the gut. Bacillus coagulans strains have been used as general nutritional supplements and agents to control constipation and diarrhea in humans and animals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic PX0612 | Experimental | PX0612 is a probiotic contained in a veggie capsule. |
|
| Di-Calcium Phosphate | Placebo Comparator | Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PX0612 | Dietary Supplement | PX0612 is a probiotic contained in a veggie capsule. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | For each patient stool frequency was measured as a number of bowel movements per day. To compare stool frequency before and after the treatment, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean score indicates a better outcome, a greater reduction in bowel movements/day and is a positive change. Placebo group- min: -.43 max: 1.43 Study group- min: -.43 max: 1.50 | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91) |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | Mean change in heartburn between baseline (days 1-14) and weeks 10 and 11 (days 78-91) between the two groups. A higher mean value indicates a greater reduction in heartburn, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of heartburn (0= no heartburn, 4= incapacitating). Placebo group- Min: -2.00 Max: 3.00 Treatment group- Min: -2.00 Max: 2.00 |
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Inclusion Criteria:
Male or female
18 - 65 years old
Signed informed consent
Mild to moderate (using Functional Bowel Disorder Severity Index (FBDSI)) IBS-Diarrhea patient:
The symptoms of IBS must persist for at least 3 months and must include:
A. Altered stool frequency (> 3 bowel movements/day or < 3 bowel movements/week) B. Altered stool form (lumpy/hard or loose/watery stools) C. Altered stool passage (straining, urgency or feeling of incomplete evacuation) D. Passage of mucus E. Bloating or feeling of abdominal distention
Note: Diarrhea is defined as having loose watery stools at least three times per day
Exclusion Criteria:
The patient will be excluded from the study if:
PX0612 In The Treatment Of Irritable Bowel Syndrome:
assessment of study medication. This should be confirmed by a pre-study medical examination performed 2 weeks prior the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Richer | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678561 | Background | Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061. | |
| 12650794 | Background | Longstreth GF, Wilson A, Knight K, Wong J, Chiou CF, Barghout V, Frech F, Ofman JJ. Irritable bowel syndrome, health care use, and costs: a U.S. managed care perspective. Am J Gastroenterol. 2003 Mar;98(3):600-7. doi: 10.1111/j.1572-0241.2003.07296.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Probiotic PX0612 | PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule. |
| FG001 | Di-Calcium Phosphate | Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Probiotic PX0612 | PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule. |
| BG001 | Di-Calcium Phosphate | Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | For each patient stool frequency was measured as a number of bowel movements per day. To compare stool frequency before and after the treatment, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean score indicates a better outcome, a greater reduction in bowel movements/day and is a positive change. Placebo group- min: -.43 max: 1.43 Study group- min: -.43 max: 1.50 | The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome. | Posted | Mean | 95% Confidence Interval | bowel movements/day | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91) |
|
Adverse events were collected during study participation over a 14 week period for each participant.
Reporting was performed as per GCP standards
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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 | Probiotic PX0612 | PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Cobb | Pharmabiotix, Inc | 214-327-4712 | cobbcoinc@aol.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: Statistical Analysis | Apr 4, 2018 | Mar 27, 2019 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Final Report Version | Nov 28, 2018 | Oct 4, 2019 | SAP_001.pdf |
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| Di-Calcium Phosphate |
| Dietary Supplement |
Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate |
|
| Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91) |
| Differences in Upper Gastrointestinal Symptoms- Vomiting Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | vomit scale used was from 0-4, the higher the number, the worse the outcome Mean change in vomiting between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in vomiting, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of vomiting(0= none, 4= incapacitating). Placebo group- Min: 0 Max: 0 Treatment group- Min: -3.00 Max: 0 | Baseline compared to Week 12 |
| Changes in the Patient's Assessment of Their Quality of Life Using Short Form(SF)-36 Health Survey PCS (Physical Component Score) | Differences in quality of life phusical component score using SF-36 between the 'intervention' group and the 'placebo' group over the study period. Baseline PCS scores were compared to the end of the study time point. The mean difference between the 2 time points was measured. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Scoring is based on software program. Placebo group- Min: -16.16 Max: 6.25 Treatment group- Min: -16.42 Max: 5.46 The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study. | Baseline compared to Week 12 (end of study) |
| Differences in Abdominal Pain/Discomfort Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | Outcome measure is the mean change of abdominal pain, on a scale of 0-4 (0= no pain, 4= incapacitating pain), between baseline and Weeks 10 and 11. A larger change in average abdominal pain indicates a greater reduction in mean abdominal pain score, better outcome. Min=-.067 for treatment group Min= -.99 for placebo group Max= 1.14 for treatment group Max= 1.63 for placebo group The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study. | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92) |
| Differences in Stool Consistency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | The stool consistency before and after the treatment was compared, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean outcome indicates a greater reduction in loose stool/diarrhea (better outcome). Bristol Stool Chart (1=severe constipation to 7 =severe diarrhea) was the scale used for measurement. The participant reported outcomes were averaged at above time points for comparison. Min for placebo group: -.70 Max for treatment group: 2.57 Max for placebo group: 1.88 The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study. | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92) |
| Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | Number of stools/day | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92) |
| Differences in Upper Gastrointestinal Symptoms- Early Satiety | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Change in rate of early satiety on a scale from 0-4 (higher the score, the worse the outcome) Mean change in early satiety between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in early satiety, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of early satiety (0= none, 4= incapacitating). Placebo group- Min: -2.00 Max: 1.00 Treatment group- Min: -2.00 Max: 2.00 | Baseline compared to Week 12 |
| The Difference in Change of Postprandial Fullness Severity | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in postprandial fullness between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in a postprandial fullness, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of postprandial fullness (0= no postprandial fullness, 4= incapacitating postprandial fullness). Placebo group- Min: -1.00 Max: 2.00 Treatment group- Min: -1.00 Max: 2.00 | Baseline compared to Week 12 |
| Upper Gastrointestinal Symptoms of Prolonged Digestion | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in prolonged digestion between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in prolonged digestion, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of prolonged digestion (0= none, 4= incapacitating). Placebo group- Min: -2.00 Max: 1.00 Treatment group- Min: -1.00 Max: 3.00 | Baseline compared to Week 12 |
| Upper Gastrointestinal Symptom of Nausea | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in nausea between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in nausea, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of nausea(0= none, 4= incapacitating). Placebo group- Min: 0.00 Max: 2.00 Treatment group- Min: -1.00 Max: 1.00 | Baseline and Week 12 |
| FBDSI (Functional Bowel Disease Severity Index) | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in bowel disease severity, better outcome. Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease. Placebo group- Min: -10.00 Max: 350.00 Treatment group- Min: 0 Max: 300.00 | Baseline compared to Week 12 |
| 10429736 | Background | Drossman DA. Review article: an integrated approach to the irritable bowel syndrome. Aliment Pharmacol Ther. 1999 May;13 Suppl 2:3-14. doi: 10.1046/j.1365-2036.1999.0130s2003.x. |
| 16696786 | Background | Schoenfeld P, Talley NJ. Measuring successful treatment of irritable bowel syndrome: is "satisfactory relief " enough? Am J Gastroenterol. 2006 May;101(5):1066-8. doi: 10.1111/j.1572-0241.2006.00519.x. |
| 20140275 | Background | Dolin BJ. Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec;31(10):655-9. doi: 10.1358/mf.2009.31.10.1441078. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Bowel Movements Per Day | Frequency of Bowel Movements Per Day, measured as total number of bowel movements per day. | Mean | Full Range | bowel movements/day |
|
| Functional Bowel Disorder Severity Index | , higher score= greater severity total score range from 0-500 | Mean | Full Range | units on a scale |
|
| Abdominal Pain- higher the number, greater the pain | The scale of pain ranges from 0-4, 4 indicating incapacitating pain. | Mean | Full Range | units on a scale |
|
| Stool Consistency | 1= solid stools 7= loose stools diarrhea | Mean | Full Range | units on a scale |
|
| Short Form 36 Health Survey | Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Scoring is based on software program. | Mean | Standard Deviation | units on a scale |
|
PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule. |
| OG001 | Di-Calcium Phosphate | Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate |
|
|
| Secondary | Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | Mean change in heartburn between baseline (days 1-14) and weeks 10 and 11 (days 78-91) between the two groups. A higher mean value indicates a greater reduction in heartburn, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of heartburn (0= no heartburn, 4= incapacitating). Placebo group- Min: -2.00 Max: 3.00 Treatment group- Min: -2.00 Max: 2.00 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91) |
|
|
|
| Secondary | Differences in Upper Gastrointestinal Symptoms- Vomiting Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | vomit scale used was from 0-4, the higher the number, the worse the outcome Mean change in vomiting between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in vomiting, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of vomiting(0= none, 4= incapacitating). Placebo group- Min: 0 Max: 0 Treatment group- Min: -3.00 Max: 0 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline compared to Week 12 |
|
|
|
| Secondary | Changes in the Patient's Assessment of Their Quality of Life Using Short Form(SF)-36 Health Survey PCS (Physical Component Score) | Differences in quality of life phusical component score using SF-36 between the 'intervention' group and the 'placebo' group over the study period. Baseline PCS scores were compared to the end of the study time point. The mean difference between the 2 time points was measured. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Scoring is based on software program. Placebo group- Min: -16.16 Max: 6.25 Treatment group- Min: -16.42 Max: 5.46 The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study. | The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline compared to Week 12 (end of study) |
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| Secondary | Differences in Abdominal Pain/Discomfort Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | Outcome measure is the mean change of abdominal pain, on a scale of 0-4 (0= no pain, 4= incapacitating pain), between baseline and Weeks 10 and 11. A larger change in average abdominal pain indicates a greater reduction in mean abdominal pain score, better outcome. Min=-.067 for treatment group Min= -.99 for placebo group Max= 1.14 for treatment group Max= 1.63 for placebo group The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study. | The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92) |
|
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| Secondary | Differences in Stool Consistency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | The stool consistency before and after the treatment was compared, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean outcome indicates a greater reduction in loose stool/diarrhea (better outcome). Bristol Stool Chart (1=severe constipation to 7 =severe diarrhea) was the scale used for measurement. The participant reported outcomes were averaged at above time points for comparison. Min for placebo group: -.70 Max for treatment group: 2.57 Max for placebo group: 1.88 The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study. | The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92) |
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| Secondary | Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. | Number of stools/day | The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome. | Posted | Mean | 95% Confidence Interval | stools/day | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92) |
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| Secondary | Differences in Upper Gastrointestinal Symptoms- Early Satiety | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Change in rate of early satiety on a scale from 0-4 (higher the score, the worse the outcome) Mean change in early satiety between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in early satiety, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of early satiety (0= none, 4= incapacitating). Placebo group- Min: -2.00 Max: 1.00 Treatment group- Min: -2.00 Max: 2.00 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline compared to Week 12 |
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| Secondary | The Difference in Change of Postprandial Fullness Severity | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in postprandial fullness between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in a postprandial fullness, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of postprandial fullness (0= no postprandial fullness, 4= incapacitating postprandial fullness). Placebo group- Min: -1.00 Max: 2.00 Treatment group- Min: -1.00 Max: 2.00 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline compared to Week 12 |
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| Secondary | Upper Gastrointestinal Symptoms of Prolonged Digestion | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in prolonged digestion between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in prolonged digestion, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of prolonged digestion (0= none, 4= incapacitating). Placebo group- Min: -2.00 Max: 1.00 Treatment group- Min: -1.00 Max: 3.00 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline compared to Week 12 |
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| Secondary | Upper Gastrointestinal Symptom of Nausea | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in nausea between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in nausea, better outcome. Analog Scale from 0-4 was used by participants to rate upper GI symptoms of nausea(0= none, 4= incapacitating). Placebo group- Min: 0.00 Max: 2.00 Treatment group- Min: -1.00 Max: 1.00 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
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| Secondary | FBDSI (Functional Bowel Disease Severity Index) | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in bowel disease severity, better outcome. Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease. Placebo group- Min: -10.00 Max: 350.00 Treatment group- Min: 0 Max: 300.00 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline compared to Week 12 |
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| Post-Hoc | Participants With 30% or More Reduction in Functional Bowel Disease Severity Index (FBDSI) | Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in bowel disease severity, better outcome. Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease. This measure represents the total number of participants that had a 30% or greater reduction in FBDSI score. | The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome. | Posted | Count of Participants | Participants | Baseline assessment compared to visit 5 assessment |
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| Post-Hoc | Unplanned Analysis- Participants With 30% or Greater Reduction in Stool Frequency/Day | Percentage of participants with a greater than 30% reduction in the number of stools/day. | The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | Di-Calcium Phosphate | Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate | 0 | 25 | 0 | 25 | 15 | 25 |
| increased bloating/gas | Gastrointestinal disorders | bloating/gas | Non-systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Hives | Non-systematic Assessment |
|
| Upper respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Respiratory | Non-systematic Assessment |
|
| Increased Restless Leg Syndrome | Nervous system disorders | Restless Leg Syndrom | Non-systematic Assessment |
|
| Lower back pain | General disorders | Pain | Non-systematic Assessment |
|
| Migraine/headache | General disorders | Migraine/headache | Non-systematic Assessment |
|
| Thyroiditis | Endocrine disorders | Thyroiditis | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Vomiting | Non-systematic Assessment |
|
| Weight gain | General disorders | Weight changes | Non-systematic Assessment |
|
| Ear pain/dizziness | General disorders | Dizziness | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Mood | Non-systematic Assessment |
|
| Chest pain | General disorders | Pain | Non-systematic Assessment |
|
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