The 84-day study on 285 subjects will examine the effects of a probiotic and postbiotic nutraceutical to positively affect discomfort associated with IBS.
A new clinical study will seek to examine the effects of a probiotic and postbiotic nutraceutical intervention on discomfort associated with irritable bowel syndrome (IBS). The three-arm, 84-day study will be conducted by contract research organization Vedic Lifesciences (Mumbai, India) on 285 subjects. Vedic is now recruiting trial participants across eight sites in India. Recruitment is expected to be completed in three to four months.
The nutraceutical being tested is a combination of probiotic strain Bifidobacterium longum ES1 plus a heat-treated postbiotic form of the strain. Adults 18-65 will be recruited for the study. Participants will be those diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) per the ROME IV criteria. These are subjects who experience recurrent abdominal pain on average at least one day per week in the last three months, associated with a change in stool frequency and stool form.
Subjects will be prohibited from taking antibiotics, which can decrease the effect of probiotics. According to Vedic, this will be “a major challenge since [antibiotics] are used extensively amidst the COVID pandemic and any other common bacterial infections.” Also prohibited are proton-pump inhibitors, bile acid sequestrants, prebiotics or any synbiotic supplements, and a FODMAP diet.
Subjects will be evaluated using the gold-standard IBS Symptom Severity Scale (IBS-SSS), Bristol Stool Scale (BSS), IBS QoL Scale (Quality of Life), APS-NRS (Abdominal Pain Severity–Numeric Rating Scale), STAI-AD scale (State-Trait Anxiety Inventory for Adults), and microbiome analysis. “The study also measures the fecal calprotectin levels as a secondary objective to assess the inflammation levels of volunteers with ROME IV IBS,” the Vedic press release adds. “This is an extremely sensitive bioassessment tool for differentiating IBS from IBD [inflammatory bowel disease]—a novel method to indicate the migration of neutrophils to the intestinal mucosa, showcasing inflammation.” The study will also employ the use of diet diaries and calorie counters.
According to Vedic’s press release, “Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the most common gastrointestinal (GI) conditions. Several extrinsic and intrinsic factors can lead to gut microbiome imbalance, and such disruptions can be associated with IBS, IBD, or, in more severe cases, colorectal cancer. Past research has suggested that the inclusion of probiotics and postbiotics can support GI health and the growth of good bacteria.”
“This study is on probiotic products that are expected to work on two mechanisms. The active ingredients may inhibit the growth of pathological bacteria and increase acetate concentration,” it adds. “Secondly, they may regulate and reduce the inflammatory cytokine response and the production of reactive oxygen species. All of these activities can lead to the maintenance of normal intestinal barrier function and potentially check intestinal permeability. These mechanisms of action are related to both IBS and IBD management, making them relevant for probiotics.”
“With their potential anti-inflammatory and gut-protective actions, this could be a game changer,” Vedic concludes. “Along with healthy individuals, those with celiac disease, Crohn’s, leaky gut due to stress and anxiety, and several compromised immunity may also benefit.”
The study’s Clinicaltrials.gov registry number is NCT05339243.