Case Report
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 21, 2015; 21(11): 3361-3366
Published online Mar 21, 2015. doi: 10.3748/wjg.v21.i11.3361
New therapeutic option for irritable bowel syndrome: Serum-derived bovine immunoglobulin
Larry Good, Roxanne Rosario, Raymond Panas
Larry Good, Department of Gastroenterology, South Nassau Communities Hospital, Oceanside, NY 11572, United States
Roxanne Rosario, Department of Research, Good Pharmaceutical Development Company, LLC, Lynbrook, NY 11563, United States
Raymond Panas, Department of Medical Affairs, Entera Health, Inc., Cary, NC 27518, United States
Author contributions: Good L and Rosario R had full access to review and pull available data from the medical records; Good L and Panas R consolidated and analyzed the collected data; Good L, Rosario R, and Panas R contributed to the organization and writing of the manuscript.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Larry Good, MD, Department of Gastroenterology, South Nassau Communities Hospital, No. 444 Merrick Road, Lynbrook, NY 11572, United States.
Telephone: +1-516-766-0300 Fax: +1-516-766-2444
Received: August 19, 2014
Peer-review started: August 20, 2014
First decision: September 27, 2014
Revised: October 17, 2014
Accepted: December 16, 2014
Article in press: December 16, 2014
Published online: March 21, 2015

Oral prescription medical foods have long been used in hospital settings but are also appropriate therapies for gastrointestinal disorders in outpatient medical practice. Oral serum-derived bovine immunoglobulin/protein isolate (SBI) has been shown in clinical studies to reduce loose stools and improve stool consistency as well as other symptoms (i.e., abdominal pain, bloating, and urgency) in patients with irritable bowel syndrome with diarrhea (IBS-D) and human immunodeficiency virus-associated enteropathy. This case series reports the outcomes of 14 IBS patients who received SBI as an addition to standard of care at an individual physician’s clinical practice. The patients: 2 IBS with constipation (IBS-C), 7 IBS-D, 2 mixed diarrhea and constipation IBS (IBS-M) and 3 undefined IBS (IBS-U; also described by some physicians as IBS-Bloating), ranged in age from 22-87 years. SBI (5 g or 10 g daily dose) was added to the patient’s current standard care and followed for several weeks to determine if symptoms were improved with the addition of SBI. Overall, 12 of the 14 patients indicated some level of improvement through direct questioning of the patients regarding changes from the prior visit. One IBS-Bloating patient had a resolution of symptoms and two patients (1 IBS-Bloating and 1 IBS-C) discontinued therapy because of insufficient relief. The 12 patients who continued on therapy reported an overall improvement in symptoms with better stool consistency, decreased frequency as well as reductions in abdominal pain, bloating, distention, and incontinence. In most cases, therapeutic effects of SBI were seen within the first four weeks of therapy with continued improvements at subsequent visits. SBI has a multifaceted mechanism of action and may help to manage IBS by providing a distinct protein source required to normalize bowel function, gastrointestinal microbiota, and nutritionally enhance tight junction protein expression between intestinal epithelial cells. SBI as a medical food provides a safe option for patients with IBS-D but may have application in other forms of IBS.

Keywords: Irritable bowel syndrome, Diarrhea, Immunoglobulin, Bovine, Serum-derived, Gastrointestinal disease, Medical food

Core tip: Oral prescription medical foods are becoming part of the outpatient medical practice and are finding new uses as a therapeutic option for gastrointestinal disorders. This case series investigates the use of oral serum-derived bovine immunoglobulin/protein isolate (SBI) in the management of differing forms of irritable bowel syndrome (IBS). Because of the multifaceted mechanism of action, SBI provides a distinct protein source to normalize bowel function, gastrointestinal microbiota, and nutritionally enhance tight junction protein expression. As such, there may be potential use for patients with other forms of IBS besides IBS-D. Additional research is needed to explore this use.