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To evaluate the effects of a Bacillus coagulans-based product on protein absorption.

A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product on protein absorption.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/04/051660
Enrollment
30
Registered
2023-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

None listed

Interventions

Intervention1: Standard protein mix and Probiotic containing B. coagulans: 2 sachets to be taken orally with water twice daily, at approximately the same time each day, preferably morning and night fo

Sponsors

Abode Biotec India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject has provided written and dated informed consent to participate in the study. 2.Subject is willing and able to comply with the protocol. 3.Healthy male/female of age 18-60 years (both inclusive). 4.Subject is in good health as determined by Principal Investigator

Exclusion criteria

Exclusion criteria: 1.Subject on protein and/ or probiotic rich diet. 2.Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrolment. 3.Subject has a history of alcohol or other drug abuse in the past year 4.Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.

Design outcomes

Primary

MeasureTime frame
1.Change in urine urea nitrogen for Bacillus coagulans-based product on protein absorption 2.Short Health Scale for GI symptoms (SHS-GI) for Bacillus coagulans-based product on protein absorption 3.Food frequency questionnaire (FFQs)Timepoint: 8 weeks

Secondary

MeasureTime frame
Safety of Bacillus coagulans-based product on protein absorptionTimepoint: 8 Weeks

Countries

India

Contacts

Public ContactDivya C

Bioagile Therapeutics Pvt. Ltd

divya@bioagiletherapeutics.com9538961761

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026