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

NCT ID: NCT02358694

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-15
• Study Completion Date: 2015-06-01

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.

Detailed Description

The study will consist of four phases:

Screening Phase: screen the patients for 2 weeks prior to enrollment in the study to establish objective criteria of disease presence and severity. Patients will maintain a daily symptom dairy. At the end of screening phase, we will calculate their quality of life and symptom severity scores based on the information provided by the patients and their family. Patients with an average score of 1 or greater over 14 days for abdominal pain and stool consistency will be selected for the open label trial of SBI.

Open Label Treatment Phase: patients enrolled will receive 4 weeks of SBI along with QOL questionnaires to complete. If the patient's global assessment is that they have improved, or if review of their diaries shows an improvement in symptom severity scores (decrease in symptom severity score by > 30% from baseline), they will be eligible for the randomization phase.

Patients, who do not have any improvements during the first 4 weeks of SBI therapy, will not be randomized. If non-responders have worsening of symptoms, they will be prescribed rescue medications as per standard of care. If non-responders choose to continue to take SBI, they will be so allowed.

Randomization Phase: Patients who qualify for this phase will be randomized either to SBI or placebo. They will take their medication for 4 more weeks and complete their questionnaires, symptom as well as QOL. After this 4 week phase all patients will be offered the Open Label Extension Phase.

Open Label Extension Phase: All patients who enter this phase will be treated with SBI for another 16 weeks.

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Active Treatment Group

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

Group Type: EXPERIMENTAL

Serum-Derived Bovine Immunoglobulin

Intervention Type: 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)

Placebo Arm

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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).

Interventions

Serum-Derived Bovine Immunoglobulin

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)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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).

Intervention Type: OTHER

Other Intervention Names

SBI; Entera

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Hyams, MD

Chair, Pediatrics Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajay Rana, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Childrens Medical Center

Locations

Connecticut Childrens Medical Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

SBI-IBS-D

Identifier Type: -

Identifier Source: org_study_id