Study on analysis of gut bacteria and their by products from stool samples
- Conditions
- Health Condition 1: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2022/02/040469
- Lead Sponsor
- For BugWorks Research India Pvt Ltd Leucine Rich Bio Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Healthy Human Volunteers:
Overall Healthy Male and female subjects of age between 30 and 70 years (both inclusive), not taking any regular medications
Ulcerative Colitis Group:
1. Subjects with documented (colonoscopy) evidence of Ulcerative colitis (UC) without complications.
Colorectal Cancer Group:
1. Subjects with documented (colonoscopy and biopsy) evidence of exclusive Colorectal Cancer (CRC) without any metastasis
Healthy Human Volunteers:
1. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention
2.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
2. Ulcerative Colitis Group:
1.Subject has had or is expected to have surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal abscess requiring surgical drainage, or other conditions that may confound study evaluations
2.Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject.
3. Colorectal Cancer Group:
1. Subjects with metastatic Colorectal Cancer
2.Subject has had or is expected to have surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal abscess requiring surgical drainage, or other conditions that may confound study evaluations
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1). Comparative difference in gut microbial signatures in healthy individuals, colorectal (CRC) and ulcerative colitis (UC) patients using BugSpeaks microbiome analytical platform <br/ ><br>2). Comparative difference in stool metabolites in healthy individuals, CRC and UC patients <br/ ><br>Timepoint: Screening Visit (Up to day 3) Baseline Visit- Day 0
- Secondary Outcome Measures
Name Time Method Adverse events occurring during screening visit till stool sample collection will be recorded.Timepoint: Screening Visit (Up to day 3) Baseline Visit- Day 0