A clinical study to evaluate and compare the safety and efficacy of a test product (Probiotic Capsule) and placebo product in healthy adult subjects.

Not Applicable

Registration Number: CTRI/2024/04/066125

Lead Sponsor: Pellucid Lifesciences Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Subjects having good general health as determined by the Investigator on the basis of medical history, physical examination and vital signs.

2) Females of Childbearing potential must have a negative urine pregnancy test performed during screening.

3) Subjects who agree to refrain from using any probiotic food or supplement, including yogurt/buttermilk during the course of this study.

4) Subjects who agree to refrain from consuming pharmaceuticals such as anti-inflammatory, immunosuppressive, and laxative agents.

5) Subjects willing to maintain a consistent diet and lifestyle routine throughout the study.

6) Subject willing to provide blood and stool samples during the study duration.

Exclusion Criteria

1) Subjects having history of acute peptic ulcer, severe GERD and/or ulcer complications or other functional GI disorder.

2) Subjects with any pathological problem associated with gastroesophageal reflux disease including Barretts esophagus and malignancy.

3) Subjects with any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition which in the opinion of the Investigator could jeopardize the safety of the subject or impact the validity of the study results or interfere with the completion of study according to the protocol.

4) Subjects who are regularly using any medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.

5) Subjects consuming probiotics or prebiotics 30 days prior to study.

6) Subjects with known allergy or hypersensitivity to probiotics and/or any ingredients of the test product.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in gut microbiome by metagenomic analysis. <br/ ><br> <br/ ><br>2. Change in Quality of life using Digestive Associated Quality of Life Questionnaire (DQLQ).Timepoint: 1. Day 00 (before product administration), Day 42 <br/ ><br> <br/ ><br>2. Day 00 (before product administration), Day 21, Day 42 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Change in Daily energy levels using Visual Analogue Scale (VAS)Timepoint: Day 00 (before product administration), Day 21, Day 42;Change in eating behavior using Three-Factor Eating Questionnaire-R18 (TFEQ-R18)Timepoint: Day 00 (before product administration), Day 21, Day 42;Change in Liver Function tests, Renal Function Tests, Random Blood glucose, Thyroid Function Test, CBC and Urine Test.Timepoint: Day 00 (before product administration), Day 42;Exploratory Endpoints: <br/ ><br>Change in Short-Chain Fatty Acids (SCFAs) using Gas Chromatography Mass SpectrometryTimepoint: Day 00 (before product administration), Day 42;Safety Endpoints: <br/ ><br>Change in Vital Signs and incidence of undesirable /adverse event. <br/ ><br>Timepoint: Day 00 (before product administration), Day 21, Day 42