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Many individuals with cystic fibrosis experience growth failure. The reasons are not clear, but inflammation of the gut in these patients seems to be one important reason. Glutathione is important to normal function of the intestine and lungs. Glutathione functions to decrease inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets trapped inside of cells, so it cannot travel to the surface of the cells and perform its proper function. Moreover, glutathione has been shown to improve nutritional status in patients with AIDS and cancer.
Investigators hypothesize that supplementation of oral glutathione to pediatric individuals with cystic fibrosis could improve growth failure.
Cystic fibrosis (CF) is known principally for its pulmonary consequences. However, for most individuals with CF, the earliest manifestations are not pulmonary, but gastro-intestinal. Many children experience growth failure. Chronic gut inflammation also develops. Research has also established that lung function scores are significantly correlated with Body Mass Index (BMI) and weight percentile in CF. Therefore, interventions to improve the gastro-intestinal dimension of CF in early childhood have the potential to ameliorate the course of the disease over the life span of the patient. Both Cochrane Database reviews and a recent review commissioned by the Cystic Fibrosis Foundation found only fair evidence for current nutritional guidelines.Therefore, there is a pressing need for a treatment for CF growth failure that is more effective and less invasive than current treatments.
The discovery that CF is associated with significantly diminished efflux of reduced glutathione (GSH) from most cells in the body offers a new perspective on the pathophysiology of this disease. GSH plays several important roles; among the most important are the following: 1) primary water-soluble antioxidant; 2) mucolytic capable of cleaving disulfide bonds; and 3) regulator of immune system function. The relationship between redox ratio (GSH:GSSG) and total glutathione (GSH+GSSG) and the initiation of inflammation is well established in the research literature.
GSH is also an important component of the epithelial lining fluid of the intestines, helping to keep intestinal mucus thin, serving to defend the intestinal system against reactive oxygen species, and keeping inflammation in check under normal circumstances. GSH is an FDA-approved treatment for AIDS-related cachexia. The growing recognition of GSH system dysfunction in CF, coupled with an established research literature on the role of GSH in gastro-intestinal function and weight gain in non-CF contexts, suggest a new intervention for growth failure in early childhood in CF patients. Specifically, investigators hypothesized that oral glutathione could effectively treat CF growth failure in pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral reduced l-glutathione | Experimental | The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. |
|
| Placebo Calcium Citrate | Placebo Comparator | The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral reduced l-glutathione | Dietary Supplement | The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Percentile at 3 Months | Weight Percentile at 3 months adjusted for sex and age | 3 months |
| Height Percentile | Height Percentile adjusted for sex and age | 3 months |
| BMI Percentile | Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age | 3 months |
| BMI Percentile | Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age. | 6 months |
| Weight Percentile | Weight percentile, adjusted for sex and age | 6 months |
| Height Percentile | The subjects were measured over the course of the study to determine if treatment improved height percentile. | 6 Months |
| Fecal Calprotectin | Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity | Forced vital capacity percent predicted | 3 months |
| FEV1 | Forced expiratory volume at one second, percent predicted |
Not provided
Inclusion Criteria:
-Diagnosis of Cystic Fibrosis by either of the following criteria: >60 sweat chloride test or paired deleterious DNA cystic fibrosis transmembrane conductance regulator (CFTR) mutations (Ambry genetics, Genetech or ARUP);
-Pancreatic insufficient as defined by doctor's prescription of pancreatic enzymes.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clark T Bishop, MD | Intermountain Health Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turin | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Reduced L-glutathione | The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
| FG001 | Placebo Calcium Citrate | The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Pediatric cystic fibrosis patients, ages 15 months to 10 years
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oral Reduced L-glutathione | The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
| BG001 | Placebo Oral Calcium Citrate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 15 months to 3 years and greater than 3 years |
| 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 | Weight Percentile at 3 Months | Weight Percentile at 3 months adjusted for sex and age | All participants. | Posted | Mean | Standard Deviation | Weight Percentile, sex and age adjusted | 3 months |
|
6 months of the trial
Patients kept a daily journal. They reported change in symptoms such as bloating, abdominal pain, as well as anorexia and hunger.
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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 | Oral Reduced L-glutathione | The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
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This trial was limited to one site. The number was relatively small. Since PFT's were not done on children under the age of 5, there is even smaller number of participants contributing PFT data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clark Bishop | Intermountain Healthcare | 385 224 7343 | clark.bishop@imail.org |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D005183 | Failure to Thrive |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| Placebo | Dietary Supplement | calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
|
| 3 months |
| Bacteriology | Expectorated sputum or throat swab | 3 months |
| Forced Vital Capacity | Percent predicted of forced vital capacity. | 6 months |
| FEV1 | Forced expiratory volume at one second, percent predicted. | 6 months |
| C-Reactive Protein (CRP) | CRP was measured to determine if this test fell during the course of treatment. | 6 months |
| White Blood Cell Count | White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test. | 6 months |
| Vitamin E | Serum Vitamin E levels were measured to determine if treatment affected this test. | 6 months |
| Alanine Aminotransferase (ALT) | ALT was measured to determine if liver function was affected by treatment over the course of the study. | 6 Months |
| Bacteriology | Expectorated sputum or throat swab | 6 Months |
| Frequency of Abdominal Pain | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Abdominal Pain | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Belching | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Belching | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Flatulence | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Flatulence | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Lack of Appetite | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Lack of Appetite | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Bloating | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Bloating | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Nausea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Nausea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Vomiting | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Vomiting | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Heart Burn | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Heart Burn | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Diarrhea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Diarrhea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of More Than 2 Bowel Movements Per Day | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of More Than 2 Bowel Movements Per Day | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
| Frequency of Less Than 2 Bowel Movements Per Week | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | 6 months |
| Severity of Less Than 2 Bowel Movements Per Week | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | 6 months |
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index Percentile | Body Mass Index for patients with standardized percentile | Mean | Standard Deviation | Percentile adjusted for age and sex |
|
| Weight Percentile | Mean | Standard Deviation | Percentile adjusted for sex and age |
|
| Height Percentile | Mean | Standard Deviation | Percentile adjusted for weight and heigh |
|
| Fecal Calprotectin | Mean | Standard Deviation | micrograms/gram feces |
|
| Forced Expiratory Volume at one second. | Forced Expiratory Volume at one second. Percentile normalized by age, height and gender. | Mean | Standard Deviation | Percent predicted |
|
| Forced Vital Capacity | Forced Vital Capacity percentile normalized by age, height and gender | Mean | Standard Deviation | Percent Predicted |
|
| Gene Mutations | Number | participants |
|
| Sweat Chloride Test | Mean | Standard Deviation | mmol/L |
|
| Participants' Lipase Intake in Units Per Day | Mean | Standard Deviation | units of lipase |
|
| Bacteriology | Number | participants |
|
| White Blood Cell Count | Total White Blood Cell Count. 1000 per cubic millimeter | Mean | Standard Deviation | 1000 cells/mm^3 |
|
| ALT | peripheral blood Alanine AminoTransferase | Mean | Standard Deviation | units per liter |
|
| Vitamin E | Peripheral blood vitamin E, micrograms per ml. | Mean | Standard Deviation | micrograms per ml. |
|
| C-Reactive Protein | C-Reactive Protein in peripheral blood | Mean | Standard Deviation | miligrams per liter |
|
| Frequency of Abdominal Pain | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Abdominal Pain | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Belching | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Belching | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Flatulence | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Flatulence | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Lack of Appetite | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Lack of Appetite | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Bloating | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Bloating | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Nausea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Nausea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Vomiting | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Vomiting | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Heart Burn | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Heart Burn | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Diarrhea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Diarrhea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of More than 2 Bowel Movements Per Day | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of More Than 2 Bowel Movements Per Day | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
| Frequency of Less Than 2 Bowel Movements Per Week | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Number | participants |
|
| Severity of Less Than 2 Bowel Movements Per Week | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Number | participants |
|
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|
| Primary | Height Percentile | Height Percentile adjusted for sex and age | All participants. | Posted | Mean | Standard Deviation | Percentile adjusted for age and sex | 3 months |
|
|
|
| Primary | BMI Percentile | Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age | BMI percentile not available for children under 2 years of age. | Posted | Mean | Standard Deviation | Percentile adjusted for age and sex | 3 months |
|
|
|
| Secondary | Forced Vital Capacity | Forced vital capacity percent predicted | Pulmonary function tests not performed on children under the age of 5 | Posted | Mean | Standard Deviation | percent predicted | 3 months |
|
|
|
| Secondary | FEV1 | Forced expiratory volume at one second, percent predicted | Pulmonary function tests not performed on children under the age of 5 | Posted | Mean | Standard Deviation | Percent predicted | 3 months |
|
|
|
| Secondary | Bacteriology | Expectorated sputum or throat swab | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Forced Vital Capacity | Percent predicted of forced vital capacity. | PFT's not done on children under age of 5. | Posted | Mean | Standard Deviation | Percent Predicted | 6 months |
|
|
|
| Secondary | FEV1 | Forced expiratory volume at one second, percent predicted. | PFT's not done on children under age of 5. | Posted | Mean | Standard Deviation | Percent predicted | 6 months |
|
|
|
| Secondary | C-Reactive Protein (CRP) | CRP was measured to determine if this test fell during the course of treatment. | All participants. | Posted | Mean | Standard Deviation | milligrams per liter | 6 months |
|
|
|
| Primary | BMI Percentile | Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age. | All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age | Posted | Mean | Standard Deviation | Percentile adjusted for age and sex | 6 months |
|
|
|
| Secondary | White Blood Cell Count | White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test. | All participants. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | 6 months |
|
|
|
| Secondary | Vitamin E | Serum Vitamin E levels were measured to determine if treatment affected this test. | All participants. | Posted | Mean | Standard Deviation | milligrams per liter | 6 months |
|
|
|
| Primary | Weight Percentile | Weight percentile, adjusted for sex and age | All participants. | Posted | Mean | Standard Deviation | Percentile adjusted for age and sex | 6 months |
|
|
|
| Primary | Height Percentile | The subjects were measured over the course of the study to determine if treatment improved height percentile. | All participants. | Posted | Mean | Standard Deviation | Percentile adjusted for age and sex | 6 Months |
|
|
|
| Primary | Fecal Calprotectin | Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome. | All participants. | Posted | Mean | Standard Deviation | Micrograms/gram feces | 6 months |
|
|
|
| Secondary | Alanine Aminotransferase (ALT) | ALT was measured to determine if liver function was affected by treatment over the course of the study. | All participants. | Posted | Mean | Standard Deviation | units per liter | 6 Months |
|
|
|
| Secondary | Bacteriology | Expectorated sputum or throat swab | Posted | Number | participants | 6 Months |
|
|
|
| Secondary | Frequency of Abdominal Pain | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Abdominal Pain | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Belching | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Belching | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Flatulence | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Flatulence | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Lack of Appetite | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Lack of Appetite | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Bloating | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Bloating | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Nausea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Nausea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Vomiting | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Vomiting | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Heart Burn | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Heart Burn | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Diarrhea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Diarrhea | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of More Than 2 Bowel Movements Per Day | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of More Than 2 Bowel Movements Per Day | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Frequency of Less Than 2 Bowel Movements Per Week | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Severity of Less Than 2 Bowel Movements Per Week | Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe | Posted | Number | participants | 6 months |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Placebo Calcium Citrate | The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime. | 0 | 22 | 0 | 22 |
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| PA |
|
| Staph |
|
| Normal flora |
|
| PA and S. maltophilia |
|
| PA and Staph |
|
| Staph and A. xylososidans |
|
| S. maltophilia |
|
| PA |
|
| Staph |
|
| Noraml flora |
|
| PA and S. maltophilia |
|
| PA and Staph |
|
| Staph and A. xylososidans |
|
| S. maltophilia |
|
| Strep B |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|
| 3- frequently |
|
| 4- constantly |
|
| Did Not Answer |
|
| 3- moderate |
|
| 4- serious |
|
| Did Not Answer |
|