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

NCT05083572 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-03-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Colonic lavage with polyethylene glycol

The subjects will orally consume a split dose of bowel preparation (PEG); 2 litres in the evening (Day -1) and another 2 litres the following morning (Day 1).

DIETARY_SUPPLEMENT

Probiotic

The subjects will self-administer orally two capsules of Vivomixx with room temperature water (as heat may inactivate the live bacteria, rendering it less effective) twice daily for 28 days.

DRUG

Antibiotic

The subjects will undergo pre-treatment to "cleanse" the gut by consuming orally one tablet of antibiotic rifaximin (200mg) daily for 14 days prior to the initiation of Vivomixx course.

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Tiing Leong Ang · Changi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083572 on ClinicalTrials.gov