Probiotics safety study on healthy human volunteers

Phase 3

• Registration Number: CTRI/2024/02/062721
• Lead Sponsor: Sami Sabinsa Group Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.1.Healthy male and female participants whose age 18 and 49 years and having Body Mass Index BMI 29.9

2.2.Participants must provide a written and signed informed consent and comply with requirements of the study.

3.

3.3.Must be able to swallow oral medications for 30 days on a daily basis and comply with

4.4.Absence of any clinically significant disease or abnormal laboratory values as decided by the PI

5. 5.Participant must consume Investigational Products only during the study. He or She must refrain from consuming any prebiotic, postbiotic, vitamins, minerals & any other supplements during the study

6. 6.Female participant of childbearing potential must use an approved method of contraception and must be willing to continue its use throughout the study duration or female participant of non-childbearing potential

Exclusion Criteria

1.Females who are planning to become pregnant in the next three months or had a positive pregnancy test at the time of screening and study period.

2.Participants with a prior history of clinically significant diseases disorders allergy.

3.Participant with any of the following shall be excluded from the study- inflammatory, autoimmune diseases, diabetes, lactose intolerance, immune deficiency, hyperthyroidism or hypothyroidism, history of GERD, gastric ulcer, and irritable bowel disease.

4.Participant with a prior history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease.

5.Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any food items, medicines, investigational product or its excipients.

6.History of organ transplantation.

7.Participants had undergone any surgery during the last six months.

8.Use of any medications within 1 month before the start of the study.

9.Use of systemic corticosteroids within 1 month before the start of the study.

10.Use of prebiotics postbiotics vitamins minerals dietary or herbal supplements within 15 days before the start of the study and not willing to refrain from the use of any new vitamins and or minerals and or dietary and or herbal supplements during the study.

11.History of difficulty in swallowing food and medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified