NCT02609529

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

November 17, 2015

Last Update Submit

March 8, 2017

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromePediatricsNutrition

Outcome Measures

Primary Outcomes (1)

  • Number of spontaneous bowel movements

    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 Outcomes (3)

  • Stool consistency

    3 weeks

  • Laboratory values

    3 weeks

  • Psychosocial

    3 weeks

Study Arms (2)

SBI

EXPERIMENTAL

Entergam 10 g/day PO

Other: Medical Food

Placebo

PLACEBO COMPARATOR

Placebo 10 g/day PO

Other: Placebo

Interventions

Medical FoodOTHER

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.

Also known as: Enteragam
SBI
PlaceboOTHER
Placebo

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males and non-pregnant females between 8 years and 18 years at the time of consent.
  • Able to obtain parental or legal guardian informed consent from subjects as applicable.
  • 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:
  • \. Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital

New Orleans, Louisiana, 70118, United States

Location

Related Publications (8)

  • Giannetti E, de'Angelis G, Turco R, Campanozzi A, Pensabene L, Salvatore S, de Seta F, Staiano A. Subtypes of irritable bowel syndrome in children: prevalence at diagnosis and at follow-up. J Pediatr. 2014 May;164(5):1099-1103.e1. doi: 10.1016/j.jpeds.2013.12.043. Epub 2014 Jan 31.

    PMID: 24485818BACKGROUND

  • Camilleri M, Lasch K, Zhou W. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. The confluence of increased permeability, inflammation, and pain in irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012 Oct;303(7):G775-85. doi: 10.1152/ajpgi.00155.2012. Epub 2012 Jul 26.

    PMID: 22837345BACKGROUND

  • Asmuth DM, Ma ZM, Albanese A, Sandler NG, Devaraj S, Knight TH, Flynn NM, Yotter T, Garcia JC, Tsuchida E, Wu TT, Douek DC, Miller CJ. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy. AIDS. 2013 Sep 10;27(14):2207-17. doi: 10.1097/QAD.0b013e328362e54c.

    PMID: 23660579BACKGROUND

  • Jiang R, Chang X, Stoll B, Fan MZ, Arthington J, Weaver E, Campbell J, Burrin DG. Dietary plasma protein reduces small intestinal growth and lamina propria cell density in early weaned pigs. J Nutr. 2000 Jan;130(1):21-6. doi: 10.1093/jn/130.1.21.

    PMID: 10613760BACKGROUND

  • Bosi P, Casini L, Finamore A, Cremokolini C, Merialdi G, Trevisi P, Nobili F, Mengheri E. Spray-dried plasma improves growth performance and reduces inflammatory status of weaned pigs challenged with enterotoxigenic Escherichia coli K88. J Anim Sci. 2004 Jun;82(6):1764-72. doi: 10.2527/2004.8261764x.

    PMID: 15217004BACKGROUND

  • Wilson D, Evans M, Weaver E, Shaw AL, Klein GL. Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome. Clin Med Insights Gastroenterol. 2013 Dec 5;6:49-60. doi: 10.4137/CGast.S13200. eCollection 2013.

    PMID: 24833942BACKGROUND

  • Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.

    PMID: 1826329BACKGROUND

  • Varni JW, Kay MT, Limbers CA, Franciosi JP, Pohl JF. PedsQL gastrointestinal symptoms module item development: qualitative methods. J Pediatr Gastroenterol Nutr. 2012 May;54(5):664-71. doi: 10.1097/MPG.0b013e31823c9b88.

    PMID: 22008958BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Paul Hyman, MD

    LSUHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 2, 2017

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

US(1)