SBI in Children With d-IBS
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|ClinicalTrials.gov Identifier: NCT02609529|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Other: Medical Food Other: Placebo||Not Applicable|
The objectives of the study are to determine whether there is improvement in gastrointestinal symptoms (i.e., number of spontaneous bowel movements. abdominal pain, stool consistency, reduction in stool number, flatulence, urgency, incontinence), in laboratory parameters, and/or in psychosocial measures in subjects with d-IBS receiving 3 weeks of SBI.
This is a randomized, double-blind, placebo-controlled, weighted, pilot study evaluating effects of SBI (10 g per day), in children or adolescents with d-IBS.
The primary outcome will be change in the number of spontaneous bowel movements from the screening week compared to the final week. This information is gathered as part of the daily diary questions.
Secondary clinical outcome variables will include changes in abdominal pain, stool consistency, flatulence, urgency, and incontinence. Further clinical outcome variables will be change in number of spontaneous bowel movements during each treatment week compared to the screening week. Stool consistency will be assessed with the Bristol Stool Form Scale. Secondary laboratory outcome variables will include changes in stool calprotectin, stool lactoferrin, erythrocyte sedimentation rate, C-reactive protein, and platelet count from the screening week and final week. Secondary psychosocial outcomes will include data from Pediatric Quality of Life Inventory for Gastrointestinal Symptoms, and the Pediatric Functional Disability Index.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Double-Blind, Randomized Pilot Study Evaluating Oral Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) on Nutritional Status in Children With Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS)|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2, 2017|
Entergam 10 g/day PO
Other: Medical Food
Serum-derived bovine immunoglobulin protein isolate will be supplied by EnteraHealth. The product is manufactured in accordance with Good Manufacturing Practice (GMP) and U.S. Food and Drug Administration (FDA) guidelines for medical food ingredients (21 CFR Part 110). Serum-derived bovine immunoglobulin protein isolate (SBI) is generally recognized as safe (GRAS). The FDA has reviewed the safety dossier for SBI as a medical food product.
Other Name: Enteragam
Placebo Comparator: Placebo
Placebo 10 g/day PO
- Number of spontaneous bowel movements [ Time Frame: 3 weeks ]The primary outcome will be change in the number of spontaneous bowel movements from the screening week compared to the final week. This information is gathered as part of the daily diary questions.
- Stool consistency [ Time Frame: 3 weeks ]Bristol Stool Scale
- Laboratory values [ Time Frame: 3 weeks ]Stool calprotectin, stool lactoferrin, ESR, CRP, platelet count
- Psychosocial [ Time Frame: 3 weeks ]Pediatric Quality of Life Inventory
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609529
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70118|
|Principal Investigator:||Paul Hyman, MD||LSUHSC|