ABSTRACT
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.
Subject(s)
Colitis, Ulcerative/diet therapy , Crohn Disease/diet therapy , Dietary Proteins/administration & dosage , Immunoglobulins/administration & dosage , Abdominal Pain/etiology , Adult , Aged , Aged, 80 and over , Animals , Cattle , Colitis, Ulcerative/complications , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/immunology , Constipation/etiology , Crohn Disease/complications , Crohn Disease/diagnosis , Crohn Disease/immunology , Diarrhea/etiology , Humans , Middle Aged , Retrospective Studies , Treatment Outcome , Young AdultABSTRACT
AIM: Chronic diarrhea with fecal incontinence (FI) is a severe, underreported, and intractable problem in many patients for which limited pharmaceutical options exist. METHODS: A retrospective case history was collected after the administration of a prescription medical food composed of serum-derived bovine immunoglobulin/protein isolate (SBI) at 5 g once daily in a patient with chronic mesenteric ischemia (CMI) for chronic loose, frequent, and urgent stools. The patient was an 84-year-old white male with a 20-year history of progressively worsening chronic diarrhea with six to eight watery stools per day (Bristol Stool Form Scale, Type 7), urgency, nocturnal diarrhea, FI, and postprandial abdominal discomfort before administration of SBI. RESULTS: After four weeks of SBI administration, the patient had two to three soft, semi-formed stools (Bristol Stool Form Scale, Types 4 and 5) per day with no nocturnal diarrhea, urgency, or FI, as well as full resolution of abdominal discomfort. In addition, the patient expressed an enhanced quality of life (QoL): able to travel, attend social events, and perform tasks not possible before therapy. CONCLUSION: This case underscores how a safe, nutritional therapy may offer a new modality for physicians to address chronic loose, frequent stools with FI in patients with CMI in this difficult to manage gastrointestinal population.
