Potential New Therapy for Patients with Refractory IBS

Entera Health, Inc. today announced a new case series report was published in the Open Journal of Gastroenterology (OJG) focusing on the use of EnteraGam, serum-derived bovine immunoglobulin/protein isolate (SBI), in patients suffering from diarrhea-predominant irritable bowel syndrome (IBS-D) or alternating between constipation and diarrhea (IBS-M) that were refractory to common IBS therapies.

Case authors, Leonard B.Weinstock, MD, and Victoria S. Jasion, PhD, initially observed 35 patient charts during this retrospective review. Of the total, only 26 qualified by either being lactose breath test (LBT) positive or negative. Unfortunately, they lost 2 of the patients to follow-up. As such, the researchers made sure to take additional precautions to ensure safety and clinical outcomes were analyzed for 24 patients who exhibited IBS-D or mixed diarrhea/constipation pattern IBS-M who were not only refractory to IBS therapies, but also had previously been screened for small intestinal bacterial overgrowth (SIBO) using a lactose breath test (LBT). Among the patients who were afflicted with LBT, only 77% had reported a favorable response to SBI therapy (N=13; p=0.04), while only 73% of patients with a positive LBT result reported a positive response to SBI therapy (N=11; p=0.117).

Researchers reported similar results when separating patients’ diagnoses: IBS-D patients had a 69% response rate to SBI (N=16; p=0.121) and IBS-M patients had a significant response rate of 88% to SBI therapy (N=8; p=0.015). When all patients were pooled (N=24), the response rate to SBI therapy was 75% (p=0.01).

The authors reported adverse events in 3 of 24 patients that led to termination of SBI. Results suggested that SBI provides for a nutritional requirement for effective management practices of chronic loose and frequent stools in patients post SIBO diagnosis. The study authors concluded, “SBI appeared to be a safe and effective nutritional moiety in refractory IBS-D and IBS-M patients. Larger, double-blind studies are needed.”