Vedic Lifesciences has announced that it is preparing to initiate investigational sites for a 3-arm, 84- day study for a Gut Health-focused Nutraceutical MNC that is bringing together the power of probiotics and post-biotics to positively affect elements of discomfort associated with Irritable Bowel Syndrome (IBS).
Diarrhoea-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 post-biotics can support GI health and the growth of good bacteria.
The focus
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, claims the European sponsor. 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.
Diet diaries will be maintained and closely monitored using a mobile app
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. Along with healthy individuals, those with celiac disease and severely compromised immunity may also benefit.
This study is going to recruit individuals across about 8 sites in India, expecting to complete the recruitment target of 285 screened participants in 3 months.
The tools being used in the study are the gold standard IBS Symptom Severity Scale (IBS-SSS), Bristol stool scale (BSS), IBS QoL (Quality of Life), and APS-NRS (Abdominal Pain Severity-Numeric rating scale), STAI-AD (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.
Antibiotics are prohibited in the study, posing a challenge considering their use in the prevailing COVID pandemic and any other common bacterial infections. Other than antibiotics, proton-pump inhibitors, bile acid sequestrants, prebiotics, or any symbiotic supplements, and a FODMAP diet are also restricted during the study.
Antibiotics are prohibited in the study
Volunteers with IBS based on ROME IV criteria, BSFS criteria 6 & 7, IBS-SSS score greater than or equal to 175 will be included whereas those diagnosed with anxiety scores greater than equal to 40, using the STAI-AD questionnaire shall be excluded.
Diet diaries will be maintained and closely monitored using a mobile app. In addition to the local regulatory guidelines, the study designed in India follows the ICH-GCP whose data is accepted across the globe and is expected to be completed by early 2023. Past safety and efficacy tests, along with a clinical study for its effect on Celiac disease have been conducted on the products, and one of the probiotics is currently marketed in the EU. More information is available on the Clinical Trials Registry - NCT05339243.
Vedic Lifesciences is a Contract Research Organisation (CRO) specialising in functional ingredient research and has managed studies for global sponsors on gut health, eye health, joint health, men's and women's health, sports nutrition, immunity and diverse other nutritional categories. In the last about four years, Vedic has successfully concluded over three other clinical studies for probiotic industry leaders, some published and others under publication.