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SBI in Children With d-IBS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609529
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
Entera Health, Inc
Information provided by (Responsible Party):
Rachel Herdes, Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Medical Food Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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 Name: Enteragam

Placebo Comparator: Placebo
Placebo 10 g/day PO
Other: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Stool consistency [ Time Frame: 3 weeks ]
    Bristol Stool Scale

  2. Laboratory values [ Time Frame: 3 weeks ]
    Stool calprotectin, stool lactoferrin, ESR, CRP, platelet count

  3. Psychosocial [ Time Frame: 3 weeks ]
    Pediatric Quality of Life Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Louisiana
Childrens Hospital
New Orleans, Louisiana, United States, 70118
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Entera Health, Inc
Investigators
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Principal Investigator: Paul Hyman, MD LSUHSC

Publications:

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Responsible Party: Rachel Herdes, Co-investigator, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02609529    
Other Study ID Numbers: IRB 8847
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Rachel Herdes, Louisiana State University Health Sciences Center in New Orleans:
Irritable Bowel Syndrome
Pediatrics
Nutrition
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs