The effects of a probiotic on gut environment in both young and elderly in an urban community in Kolkata, INDIA

The effects of a probiotic fermented milk drink, on the intestinal microbiota and intestinal environment in both young and elderly healthy individuals in an urban community in Kolkata, INDIA - PROBIOTIC-MICROBIOTA STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002491

Enrollment

160

Registered

2012-03-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: L. casei Shirota fermented milk drink: Fermented milk drink containing over 6.5Ã?109 CFUs of L. casei Shirota/65 mL, 1 bottle/day for 8 weeks (56 days. Control Intervention1: Non-fermen

Eligibility

Inclusion criteria

Inclusion criteria: 1.Young group, 25-45 years old, Elderly group:65-75 years old; healthy people. 2.No history of an adverse reaction to any of the components of the active or placebo versions of the probiotic product. 3.Can eat breakfast, lunch and dinner, regularly. 4.Has been diagnosed by doctors as healthy both physically and mentally (no diabetes etc). 5.Can abide by the experimental protocol.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating female or planning pregnancy during the study. 2.Unable to abstain from antibiotics or laxatives during the study. 3.History of GI surgery (except appendectomy).

Design outcomes

Primary

Measure	Time frame
Changes of intestinal microbiota and intestinal environment ã?»Increase in beneficial bacteria (ex. Bifidobacterium) ã?»Decrease in harmful bacteria (C. perfringens, C. difficile, Vibrio cholerae/mimicus, Vibrio parahaemolyticus, Campylobacter jejuni/coli, Shigella spp, E. coli etc.) ã?»Increase in the amount of Short Chain Fatty Acids Timepoint: From day 36 to 91 subjects will drink either 1 bottle of placebo or 1 bottle of intervention agent and 5 fecal samples from each subjects will be collected and tested on/from day 49, 63, 77, 91 and 105.	—

Measure

Time frame

Changes of intestinal microbiota and intestinal environment ã?»Increase in beneficial bacteria (ex. Bifidobacterium) ã?»Decrease in harmful bacteria (C. perfringens, C. difficile, Vibrio cholerae/mimicus, Vibrio parahaemolyticus, Campylobacter jejuni/coli, Shigella spp, E. coli etc.) ã?»Increase in the amount of Short Chain Fatty Acids Timepoint: From day 36 to 91 subjects will drink either 1 bottle of placebo or 1 bottle of intervention agent and 5 fecal samples from each subjects will be collected and tested on/from day 49, 63, 77, 91 and 105.

—

Secondary

Measure	Time frame
Beneficial changes of score from questionnairesTimepoint: Questionnaires from each subject will be collected on/from day 49, 63, 77, 91 and 105.	—

Countries

India

Contacts

Public ContactDr Suman Kanungo

NATIONAL INSTITUTE OF CHOLERA AND ENTERIC DISEASES

sumankanungo@gmail.com91-33-2370-5533

Outcome results