Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS

NCT02358694 | Completed

• 1 other identifier: SBI-IBS-D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D. Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better than the patients who receive placebo.

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Keywords

IBS; IBS-D; SBI

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  The ability of children to take SBI and related side effects

  Intervals from 0 to 4 weeks and from 4 to 8 weeks

Secondary Outcomes (1)

• Quality of Life Scores

  Assessed at Day 0, 4 weeks and 8 weeks

Study Arms (2)

Active Treatment Group

EXPERIMENTAL

Patients who weigh less than 40 Kg will receive 5 g daily (2.5 g PO BID) of Serum-derived bovine immunoglobulin/ protein isolate Patients who weigh 40 Kg or more will receive 10 g daily (5 g PO BID) of Serum-derived bovine immunoglobulin/ protein isolate

Dietary Supplement: Serum-Derived Bovine Immunoglobulin

Placebo Arm

PLACEBO COMPARATOR

The placebo group will receive a hydrolyzed gelatin protein for next 4 weeks on a daily basis.

Other: Placebo

Interventions

Serum-Derived Bovine Immunoglobulin DIETARY_SUPPLEMENT

Patients who weigh less than 40 Kg will receive Serum Derived Bovine Immunoglobulin -5 g daily (2.5 g PO BID) and patients who weigh 40 Kg or more will receive Serum Derived Bovine Immunoglobulin- 10 g daily (5 g PO BID)

Also known as: SBI, Entera

Active Treatment Group

Placebo OTHER

Matching placebo packets will be supplied and will appear identical to SBI with respect to volume, appearance and taste. Patients who weigh less than 40 Kg will take one-half packet BID (2.5 g BID) Patients who weigh 40 Kg or more will take one packet BID (5 g PO BID).

Placebo Arm

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female patients \> 8 years of age and \< 18 years of age
• Patients with a diagnosis of IBS-D as per Rome III criteria
• Patients with normal laboratory work up (CBC, ESR, CRP, amylase, lipase, celiac panel, fecal occult blood)
• Patients with normal fecal calprotectin and lactose hydrogen breath test
• Patients off motility drugs, NSAIDs for at least 2 weeks prior to enrollment in the study
• Ability to complete the study
• Patients on stable doses or other medications for at least 4 weeks prior to enrollment

You may not qualify if:

• Patients with h/o other GI, hepatic, renal, cardiovascular, neurologic or hematological disorder
• Patients with family history of inflammatory bowel disease
• Patients with history of abdominal surgery
• Patient with history of drug or alcohol abuse
• Patient with a history of allergy to study related products (e.g. beef)
• Use of probiotics in the previous month
• Patients who used SBI in the past
• Patients with soy allergy/sensitivity

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Childrens Medical Center

Farmington, Connecticut, 06106, United States

Location

Study Officials

• Ajay Rana, MD

  Connecticut Childrens Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Pediatrics Gastroenterology

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: February 9, 2015
• Study Start: June 15, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

US (1)