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NCT02609529 · ClinicalTrials.gov registry record · NA

SBI in Children With d-IBS

A NA study of Irritable Bowel Syndrome, sponsored by Louisiana State University Health Sciences Center in New Orleans.

Completed
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT02609529: Completed NA study of Irritable Bowel Syndrome, sponsored by Louisiana State University Health Sciences Center in New Orleans.

NCT02609529 is a NA study of Irritable Bowel Syndrome that has completed, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 20 participants, below the 144-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02609529, a NA study of Irritable Bowel Syndrome, has completed, sponsored by Louisiana State University Health Sciences Center in New Orleans.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Conditions Studied

Irritable Bowel Syndrome

Interventions

  • OTHER Placebo
  • OTHER Medical Food

Study Locations (1)

Louisiana

  • Childrens Hospital - New Orleans

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2015-11
Est. Completion 2017-03-02
Phase NA
Louisiana State University Health Sciences Center in New Orleans

45 total trials

What the finished NCT02609529 record still lists

NCT02609529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 144-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (86% lower).

The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02609529 reports a single indexed study location in Louisiana.

Frequently Asked Questions

What is clinical trial NCT02609529 about?

NCT02609529 is a clinical study titled "SBI in Children With d-IBS". 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...

What is the current status of trial NCT02609529?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-11. Estimated completion is 2017-03-02.

What conditions does trial NCT02609529 study?

This clinical trial studies the following conditions: Irritable Bowel Syndrome.

What interventions are being tested in trial NCT02609529?

The interventions under investigation include: Placebo (OTHER), Medical Food (OTHER).

Who is sponsoring clinical trial NCT02609529?

This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02609529 being conducted?

This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Irritable Bowel Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02609529's enrollment target sits among peer trials

20 44th of 47 higher than 3 of 47 other Irritable Bowel Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02609529, the US trial registry maintained by the National Library of Medicine. NCT02609529 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.