Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
For BugWorks Research India Pvt Ltd Leucine Rich Bio Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1). Comparative difference in gut microbial signatures in healthy individuals, colorectal (CRC) and ulcerative colitis (UC) patients using BugSpeaks microbiome analytical platform 2). Comparative difference in stool metabolites in healthy individuals, CRC and UC patients Timepoint: Screening Visit (Up to day 3) Baseline Visit- Day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events occurring during screening visit till stool sample collection will be recorded.Timepoint: Screening Visit (Up to day 3) Baseline Visit- Day 0 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed