A clinical trial to evaluate effects of Metabiotics of bacillus subtilis (B-2335) in Healthy Subjects

Phase 3

Completed

• Registration Number: CTRI/2022/04/041610
• Lead Sponsor: PRG Pharma Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-12
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

1.Free from any disorders or diseases

2. Willing to provide information on questionnaires either in person or electronically or via phone

3. Willing to comply with the study dose consumption.

Exclusion Criteria

1. Currently being treated for any physician diagnosed diseases.

2. Having a Body Mass Index of <20kg/m2 or > 30 kg/m2

3. Currently taking a probiotic or probiotic. Individuals who currently report as taking a probiotic will be allowed entry into study protocol if a wash-out period of 30 days is observed.)

4. Currently consuming any form of dietary supplements. Individuals who currently report as taking any type of supplements will be allowed entry into study protocol if a wash-out period of 30 days is observed.

5. Women who are lactating, know that they are pregnant or are attempting to get pregnant.

6. Have received chemotherapy or other immune suppressing therapy within the last year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline Gastrointestinal Symptom at 4 weeks [Time Frame: Before and after treatment (4 weeks) ] compared to Placebo; Gastrointestinal Symptom Rating ScaleTimepoint: Day 0, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
1. Changes in stool consistency (Bristol stool scale) and ease of passage compared to placebo <br/ ><br>2. WHO ââ?¬â?? QOL BREF Assessment [Time Frame: Before and after treatment (4 weeks) ] compared to Placebo <br/ ><br>3. Immune health, measured by questionnaire data <br/ ><br>4. SF-36 ââ?¬â?? General Health Questionnaire. <br/ ><br>5. Tolerability and Adverse Event occurrence assessment <br/ ><br>6. Complete Blood Count assessment (Change from Baseline) <br/ ><br>7. Lipid Profile assessment(Change from Baseline) <br/ ><br>8. Liver Function assessment(Change from Baseline) <br/ ><br>9. Kidney Function markers assessment(Change from Baseline) <br/ ><br>10. Blood Glucose assessment(Change from Baseline) <br/ ><br>11. Inflammatory markers (ESR)assessment(Change from Baseline) <br/ ><br>Timepoint: Day 0, Day 30, Day 60