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

A randomized, double blind, placebo-controlled study to evaluate the Efficacy and safety profile of Active Metabolites of B. subtilis (B-2335) in Healthy Subjects - AMEBS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041610

Enrollment

100

Registered

2022-04-04

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Active Metabolites Extract of Bacillus Subtilis strain 3 (B-2335): 500mg capsules to be consumed twice a day for 30 days Control Intervention1: Placebo: 500mg capsules to be consumed tw

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Currently being treated for any physician diagnosed diseases. 2. Having a Body Mass Index of 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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactManish Goel

PRG Pharma Pvt. Ltd.

regulatoryaffairs@prgpharma.com91-9868061439

Outcome results