SBI in Children With d-IBS

Irritable Bowel Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609529
• Other study ID #: IRB 8847
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: March 8, 2017
• Start date: November 2015
• Est. completion date: March 2, 2017

Study information

• Verified date: March 2017
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.
• Placebo

Locations

Country	Name	City	State
United States	Childrens Hospital	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	Entera Health, Inc

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stool consistency	Bristol Stool Scale	3 weeks
Secondary	Laboratory values	Stool calprotectin, stool lactoferrin, ESR, CRP, platelet count	3 weeks
Secondary	Psychosocial	Pediatric Quality of Life Inventory	3 weeks