Effect of Probiotic (VSL#3) on Gut Microbiome and Bacterial Translocation in Healthy Asian Volunteers

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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 VSL#3 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 (VSL#3). This has important clinical implications in designing treatment strategies in clinical practice such as the use of VSL#3 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Changi General Hospital
• Treatments: Anti-Bacterial Agents; Rifaximin

Criteria

Inclusion Criteria:

1. Provision of signed written informed consent,

2. Aged between 21-65 years of age,

3. Chinese, Malay or Indian ancestry through three generations,

4. Body Weight ≥ 50kg, Body Mass Index (BMI) of 18.5 to 29.9 kg/m2, inclusive,

5. Clinical laboratory assessment results within normal limits, unless the deviation is considered not clinically significant by the investigator,

6. Regular stool every 1-2 days,

7. Satisfactory medical assessment as assessed by physical examination, medical history, and normal laboratory values or minor variations that are not clinically significant,

8. Ability to communicate with the investigator and to understand and comply with all requirements of study participation.

9. Both male and female participants (with child-bearing potential) and their partners have to practise contraception throughout the duration of the study.

Exclusion Criteria:

1. Any acute illness within 14 days of first dosing, unless otherwise approved by the PI,

2. History or evidence of clinically significant hepatic, renal, cardiovascular, respiratory, gastrointestinal, immunosuppressive or metabolic disorders, any cancer types,

3. Declare themselves positive for HIV or viral hepatitis (Hepatitis A, B, C),

4. Treatment within the previous 3 months with antibiotics (subjects are to inform study staff should they be prescribed antibiotics during the course of the study)

5. Treatment with any prescription or over-the-counter medications, complementary health products, or herbal supplements within 28 days of first dosing,

6. Consumption of probiotics or lactobacillus-containing products e.g. Yakult, Vitagen or Yogurt within 4 weeks of first dosing unless approved by the PI,

7. Abnormal biochemistry indicators, unless certified as not clinically significant,

8. Poor peripheral venous access,

9. Irregular bowel habits or complains of constipation problem,

10. Pregnancy or lactation,

11. Known allergic reactions to rifaximin, PEG or VSL#3,

12. History of drug/alcohol abuse,

13. Involvement in the planning or conduct of this study.