SBI in Children With d-IBS

March 8, 2017 updated by: Rachel Herdes, Louisiana State University Health Sciences Center in New Orleans

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and non-pregnant females between 8 years and 18 years at the time of consent.
  2. Able to obtain parental or legal guardian informed consent from subjects as applicable.
  3. d-IBS determined by ROME III criteria. A Rome III diagnosis consists of recurrent abdominal pain or discomfort at least 2days/week in the last 3 months prior to enrollment associated with two or more of the following10:

1. Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool.

Exclusion Criteria:

  1. Children taking pharmacologic treatment for d-IBS will be excluded.
  2. Children who are unable to articulate symptoms of IBS will be excluded.
  3. Non-English speaking children will be excluded.
  4. Children with known allergy or hypersensitivity to beef or any component of SBI.
  5. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBI
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 Names:
  • Enteragam
Placebo Comparator: Placebo
Placebo 10 g/day PO
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool consistency
Time Frame: 3 weeks
Bristol Stool Scale
3 weeks
Laboratory values
Time Frame: 3 weeks
Stool calprotectin, stool lactoferrin, ESR, CRP, platelet count
3 weeks
Psychosocial
Time Frame: 3 weeks
Pediatric Quality of Life Inventory
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

Entera Health, Inc

Investigators

  • Principal Investigator: Paul Hyman, MD, LSUHSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 2, 2017

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 8847

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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