FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095832 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross-sectional and longitudinal (prospective) 
Study Design  Other 
Public Title of Study   Studying how gut bacteria and body chemicals differ in people with ulcerative colitis compared to healthy individuals to improve future treatment options. 
Scientific Title of Study   Exploring the role of human gut microbiome and metabolites in ulcerative colitis: an approach towards clinical implications and precision medicine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shiran Shetty 
Designation  Professor and Unit Head 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  shiran.shetty@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Shiran Shetty 
Designation  Professor and Unit Head 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  shiran.shetty@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shiran Shetty 
Designation  Professor and Unit Head 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  shiran.shetty@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shiran Shetty  Kasturba Medical College, Manipal  Department of Gastroenterology and Hepatology, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA 		 8861920517

shiran.shetty@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non Ulcerative Colitis patients 
Patients  (1) ICD-10 Condition: K518||Other ulcerative colitis, (2) ICD-10 Condition: K510||Ulcerative (chronic) pancolitis, (3) ICD-10 Condition: K512||Ulcerative (chronic) proctitis, (4) ICD-10 Condition: K513||Ulcerative (chronic) rectosigmoiditis, (5) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult participants diagnosed with ulcerative colitis based on clinical criteria, including colonoscopy and histopathological confirmation.
UC patients at different disease stages (newly diagnosed, active, and in remission).
Age- and gender-matched healthy controls for comparison.
 
 
ExclusionCriteria 
Details  History of other gastrointestinal diseases.
Recent use (within the last 6 months) of Antibiotics, Anti-diabetic drugs or Immunosuppressive treatments
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Microbial diversity and richness (e.g., Shannon index, alpha-diversity, beta-diversity)

Metabolomic profile differences between UC and healthy individuals.

Presence and frequency of genetic mutations correlated with gut dysbiosis.
 		 At baseline, fecal, blood, and tissue samples from ulcerative colitis patients and healthy controls will be analyzed for gut microbial diversity, genetic mutations, and metabolite profiles. At 6 months, repeat samples from ulcerative colitis patients will assess temporal changes. At 12 months, follow up will evaluate stability or progression of dysbiosis and metabolomic changes. 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between specific gene mutations & changes in microbiome composition.
Identification of metabolite biomarkers linked to disease severity.
Functional microbial pathway analysis indicating inflammation drivers.
Differentiation of UC severity stages using combined microbiome–genomic–metabolomic data.
 		 At baseline, microbial pathway functions, disease activity correlation, & metabolite markers of severity will be assessed. At 6 months, changes in microbiome & metabolite patterns will be linked with clinical improvement or relapse. At 12 months, integrated gene-microbiome-metabolite data will be analyzed to predict disease progression & outcomes. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a prospective observational study designed to understand how gut bacteria and body chemicals influence ulcerative colitis in the Indian population. Ulcerative colitis is a long term inflammatory disease of the colon that causes symptoms such as abdominal pain, diarrhea, and bleeding. The study will compare the gut microbiome and metabolite profiles of patients with ulcerative colitis and healthy individuals to identify specific bacterial and metabolic changes linked to the disease.

About 200 participants will be included, 100 with ulcerative colitis and 100 healthy controls matched for age and sex. Stool, blood, and biopsy samples will be collected for analysis. The study will also include a smaller follow up group of ulcerative colitis patients to observe changes over time. The samples will be processed using advanced genomic and metabolomic techniques to identify differences in gut microbes, metabolites, and genetic markers.

This research does not involve any new drug or device. Participants will continue their routine medical care as advised by their treating doctors. All data will be coded to maintain confidentiality. The information gained from this study may help in understanding disease mechanisms, identifying early biomarkers, and guiding the development of personalized or microbiome based treatment strategies for ulcerative colitis in the future.

 
Close