Serum-derived bovine immunoglobulin for children with diarrhea-predominant irritable bowel syndrome

Abstract

Background

Oral serum-derived bovine immunoglobulin (SBI)/protein isolate is a medical food intended to manage chronic diarrhea. It has been shown to improve pain and diarrhea in adults with diarrhea-predominant irritable bowel syndrome (d-IBS).

Aim

To determine if SBI can improve symptoms in children with d-IBS.

Methods

We performed a randomized, double-blind, placebo-controlled, pilot study (NCT02609529) to evaluate the effectiveness of SBI in children 8–18 years with d-IBS. We recorded stool number, abdominal pain, and stool form in all patients for 1 week and then assigned the patients at a ratio of 2:1 to treatment with SBI 5 g BID or placebo for 3 weeks. The patients and their parents completed the Pediatric Quality of Life Inventory™ for Gastrointestinal Symptoms (PedsQOL) and the Pediatric Functional Disability Index (FDI). In addition, complete blood counts and serum chemistries were recorded at the start and end of treatment to evaluate safety.

Results

Fifteen patients (nine SBI, six placebo) completed the study. Both SBI and placebo groups reported nonstatistical reductions in stool frequency per week. The SBI group showed a significant reduction in stool frequency at weeks 1 and 2 but not at the end of treatment. The SBI group also demonstrated statistical improvements in abdominal pain and stool form by 3 weeks. The placebo group did not achieve similar improvements. The overall FDI and PedsQOL scores, as well as PedsQOL subscale scores for pain, discomfort when eating, diarrhea, worry about stomach aches, and communication, improved significantly in the SBI group, but not in the placebo group. No serious adverse events occurred. Serum chemistries and hemograms were normal at baseline and at the end of study in all patients.

Conclusion

In this single-center, exploratory pilot study, we demonstrated that 10 g SBI per day was safe in children with d-IBS and improved symptoms. Larger studies, with longer treatment duration, seem warranted based on these initial positive results.

Keywords:

• pediatric
• irritable bowel syndrome
• diarrhea
• abdominal pain

Acknowledgments

The authors would like to acknowledge Bruce Burnett, PhD, and Raymond Panas, PhD (Medical Affairs, RedHill Biopharma, Inc., Cary, NC, USA), for their editorial support and review efforts in the preparation and finalization of this manuscript. The abstract of this manuscript was presented as a poster at the North American Society for Pediatric Gas-troenterology, Hepatology and Nutrition Annual Meeting on 14 November 2017 in Las Vegas, NV, USA.

Author contributions

Each of the authors contributed to the planning and development of the manuscript. Dr Rami Arrouk, Dr Rachel E Herdes, and Dr Paul E Hyman recruited subjects for the study and served as the attending physicians for the subjects care. Dr Aryn C Karpinski provided statistical support for the analysis of the data. All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.