ABSTRACT & COMMENTARY
Treatment of IBS Without Constipation with Rifaximin Versus a Spore-Based Probiotic
Evaluation of symptom severity, quality of life, and rectal sensation REFERENCE
Catinean A, Neag AM, Nita A, Buzea M, Buzoianu AD. Bacillus spp. spores—a promising treatment option for patients with irritable bowel syndrome. Nutrients. 2019;11(9):1968. OBJECTIVE
The aim of this study was to compare rifaximin followed by a nutraceutical or low–fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet to stand-alone therapy with a spore-based probiotic (MegaSporeBiotic) in patients with irritable bowel syndrome (IBS) without constipation. DESIGN
A nonblinded, prospective, randomized, controlled clinical study. Participants were randomized to 3 groups: • G1, in which participants received a 10-day course of rifaximin (1,200 mg) followed by a 24-day course of a nutraceutical containing Bifidobacterium longum W11, soluble fiber, and vitamins B1, B2, B6, and B12. • G2, in which participants received a 34-day course of Bacillus spp probiotic (Bacillus licheniformis, Bacillus indicus HU36™, Bacillus subtilis HU58™, Bacillus clausii, Bacillus coagulans, all from the MegaSporeBiotic brand). • G3, in which participants received a 10-day course of rifaximin (1,200 mg) followed by a 24-day low-FODMAP diet. The researchers obtained outcome measures at baseline, day 10 (for groups G1 and G3), day 34, and day 60. PARTICIPANTS
This study included 90 patients with IBS without constipation based on Rome III criteria. Patients were aged 18 to 75 years with a normal colonoscopy in the last 5 years, blood counts within reference values, and normal fecal calprotectin. Patients with documented food allergies, gluten intolerance or celiac disease, diabetes, thyroid disease, intestinal inflammatory disease or other organic diseases, eating disorders (anorexia or bulimia), probiotics 1 month before the study, antibiotic treatment in the previous 6 months, or specific diets were excluded. STUDY PARAMETERS ASSESSED
Researchers evaluated patients based on the IBS severity score (IBS-SS), quality of life for IBS patients (IBS-QL), and a rectal volume sensation test. KEY FINDINGS
IBS-SS improved at each outcome measurement for G1, G2, and G3 and, interestingly, improved equally by the end of the study. The MegaSporeBiotic group, G2, did have earlier symptom improvement at the 3rd visit (day 34). Quality-of-life scores and the rectal volume sensation testing also improved in every group, with similar outcomes in each group. 20 ©2020 NATURAL MEDICINE JOURNAL. ALL RIGHTS RESERVED. NMJ, MAY 2020 SUPPLEMENT—VOL. 12, NO. 51 (SUPPL)
Alena Guggenheim, ND
PRACTICE IMPLICATIONS Irritable bowel syndrome is a common disorder that affects approximately 10% of the population, with significant gaps in reliable and cost-effective treatment strategies.1 Our understanding of pathophysiology is rapidly expanding using systemic biology. The current proposed model is a complex web of dysfunction of the gut microbiota, altered intestinal permeability, altered motility, gastrointestinal (GI) immune-cell activation, visceral hypersensitivity, and abnormal gut-brain interactions.2 Rifaximin first emerged as an effective treatment option to alter GI microbiota in 2011 with the TARGET trial, which eventually led to the FDA approval of rifaximin as a treatment for IBS with diarrhea in 2015.3 This study aims to show that nonantibiotic therapy may also be effective to treat IBS with diarrhea (IBS-D) through the alteration of the microbiome via a spore-based probiotic. This study does contain multiple significant limitations, many of which the authors acknowledge. These include a lack of blinding and placebo, moderate rather than severe symptoms at baseline, a lack of breath testing for small intestinal bacterial overgrowth (SIBO), and the use of Rome III rather than Rome IV criteria. The researchers used Rome III because this study started prior to ROME IV, and the authors note that 90% of participants also met the new criteria. There are additional limitations not discussed by the authors. The first, and perhaps most important, is that the rifaximin treatment group was undertreated in both dose and duration. The current universally accepted (continued on page 22)
