drugset / Trial / NCT05083572

Effect of Probiotic on Gut Microbiome and Bacterial Translocation in Healthy Asian Volunteers

NCT05083572

Phase 4 Unknown 32 enrolled Changi General Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Dysbiosis of the gut microbiome has been recognized to underlie the pathogenesis of various gastrointestinal conditions. Probiotics are known to exert beneficial effects on gut health and have great potential for use as microbiome interventions for gastrointestinal and metabolic diseases. While it is widely known that probiotic bacteria favourably alter the intestinal microflora balance, their other mechanisms of action have not been systematically characterized. The ability of probiotics to modulate dysbiosis may lead to reduced levels of endotoxaemia and oxidative stress. In this study, the investigators propose to examine the effects of 4-week Vivomixx treatment on the gut microbiome and bacterial translocation in healthy Asian volunteers with and without colonic lavage or antibiotic treatment. The study will also examine the same outcome parameters 4 weeks upon cessation of the product. The findings derived from the study will provide valuable insights into the microbiota changes associated with colonic lavage or antibiotic treatment, and the use of probiotic (Vivomixx). This has important clinical implications in designing treatment strategies in clinical practice such as the use of Vivomixx as microbiome interventions with antibiotics which are known to induce Clostridium difficile-associated diarrhoea, as well as in the therapeutic management of various diseases associated with dysbiosis.

Timeline

Start
2021-03-10
Primary completion
2022-11-30
Completion
2022-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Vivomixx Other / unclassified Oral
Background Rifaximin Other / unclassified 200 mg Oral
Background polyethylene glycol Other / unclassified 2000 ml Oral