A Study to Evaluate Clinical Safety of Heat Inactivated Bacillus coagulans in Healthy Human Participants.

Phase 4

Not yet recruiting

• Conditions: Healthy Human Participants in clinical investigative sites

• Registration Number: CTRI/2023/01/048914
• Lead Sponsor: Sami-Sabinsa Group Limited

Brief Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Two-arm, Parallel Study to Evaluate the Clinical Safety of Heat Inactivated *Bacillus coagulans* (*Weizmannia coagulans*) MTCC 5856 in Healthy Human Participants. Healthy male/non-pregnant, non-lactating female aged between 18 to 49 years will be enrolled in the study. Participants shall be randomized in a ratio of 1:1 into one of the two treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-16
• Last Update Posted: 2023-04-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy male or non-pregnant, non-lactating female participants aged between 18 to 49 years both inclusive and having Body Mass Index (BMI) ≤28 Kg/m2.
• Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation at baseline measurement.
• Participant willing to refrain from consuming probiotic and postbiotic supplements during the study.
• Participant able to swallow and retain orally administered medication.
• Female participant of childbearing potential practicing an approved method of contraception and willing to continue its use throughout the study duration or female participant of non-childbearing potential.
• Participant willing and able to provide written informed consent before any study procedures are performed.
• Participant shall be willing and able to understand and comply with the requirements of the study, consume the Investigational Product as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.

Exclusion Criteria

• Females who are planning to become pregnant in three months or have a positive pregnancy test (females of childbearing potential) at screening.
• Participant who has not taken two doses of vaccination for COVID-19 as per the government guidelines.
• Participant education level below 8th grade of schooling.
• Participant with or having a prior history of clinically significant diseases/disorders and/or any kind of allergy.
• Participant with inflammatory, autoimmune diseases, diabetes, lactose intolerance, immune deficiency, hyperthyroidism or non-medically adjusted hypothyroidism, and coeliac disease.
• Participant with or having a prior history of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease.
• History of organ transplantation.
• Participant has undergone surgery during the last six months.
• Use of antipsychotic medications within 3 months before the start of the study.
• Use of systemic corticosteroids within 1 month before the start of the study.
• 11.Use of vitamin/ mineral/ 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.
• Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any investigational product or its excipients etc.
• History of difficulty in swallowing.
• Smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
• Alcohol dependence, alcohol abuse, or drug abuse or addiction to any recreational drug within the past 6 months.
• Significantly abnormal 12 lead ECG findings.
• Participant with clinically significant abnormal laboratory values.
• Patients deemed uncooperative or noncompliant.
• Participation in another clinical trial within the preceding 90 days of the study starts.
• Any other condition that the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of adverse reactions	Day 1 to Day 31 | Screening to Day 31
Change in vital signs, laboratory parameters	Day 1 to Day 31 | Screening to Day 31

Secondary Outcome Measures

Name	Time	Method
•Mean change in serum Immunoglobulin IgG levels between groups	•Mean change in serum Immunoglobulin IgE levels between groups

Trial Locations

Locations (2)

Lifepoint Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Ojas Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Lifepoint Multispeciality Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Shivnitwar Sachin Kisan

Principal investigator

9730475068

sachinshivnitwar94@gmail.com