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SBI in Children With d-IBS

NCT02609529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-09

No results posted yet for this study

Summary

IBS is the most common diagnosis in new patients in our pediatric gastroenterology clinic, accounting for 36 % of all new patients. Pediatric IBS patients always have a problem with defecation, characterized either as diarrhea predominant or constipation predominant. About one third of pediatric IBS subjects have d-IBS. There are no FDA approved treatments for children with d-IBS. There is evidence that diarrhea predominant irritable bowel syndrome d-IBS may be caused by a mild inflammation in the intestinal lining. Oral serum-derived bovine immunoglobulin protein isolate (SBI) is a medical food, believed to treat mild inflammation in the small intestine associated with some cases of d-IBS, especially those arising after acute gastroenteritis. It improved pain and diarrhea in adults with d-IBS. Our aim is to determine if SBI improves the number of spontaneous bowel movements in children with d-IBS.

Conditions

  • Irritable Bowel Syndrome

Interventions

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

Placebo

Sponsors & Collaborators

  • Entera Health, Inc

    collaborator INDUSTRY

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • Paul Hyman, MD · LSUHSC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-03-31
Completion
2017-03-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609529 on ClinicalTrials.gov