Health Condition 1: K518- Other ulcerative colitis Health Condition 2: K510- Ulcerative (chronic) pancolitis Health Condition 3: K512- Ulcerative (chronic) proctitis Health Condition 4: K513- Ulcerative (chronic) rectosigmoiditis Health Condition 5: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: History of other gastrointestinal diseases. Recent use (within the last 6 months) of Antibiotics, Anti-diabetic drugs or Immunosuppressive treatments
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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. | — |
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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. | — |
Countries
India
Contacts
Public ContactShiran Shetty
Manipal Academy of Higher Education
Outcome results
None listed