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Optimizing the role of Thiopurines therapy in Inflammatory Bowel Disease

Thiopurines therapy in Inflammatory Bowel Disease: Role of a spectrum of metabolites and enzymes in predicting the response

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/05/024976
Enrollment
84
Registered
2020-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K50-K52- Noninfective enteritis and colitis

Interventions

None listed

Sponsors

Shailesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a definite diagnosis of Ulcerative Colitis (UC) or Crohnâ??s Disease (CD) being initiated on azathioprine/6-mercaptopurine/ 6Tioguanine therapy (designated as thiopurine (TP) therapy) as per standard accepted criteria will be included.

Exclusion criteria

Exclusion criteria: 1. Patients with CD or UC on biologicals, or immunosuppressives other than thiopurines 2. Subjects who have undergone total procto-coloctomy for UC 3. Evidence of colorectal dysplasia or malignancies 4. Patients in whom bowel surgery appears to be imminent 5. Congenital or acquired immunodeficiency, especially known HIV infections, or evidence of other immuno-compromised states 6. Patients ineligible in any way for TP therapy e. g. known intolerance to the drug 7. Patients not providing written informed consent for inclusion 8. Planning to conceive in 17weeks after initiation of therapy

Design outcomes

Primary

MeasureTime frame
1. Quantifying Thiopurine metabolites,TPMT,IMPDH,ITPase,HGPRT enzymes using LC-MS/MS 2. Comparision of the metabloites and Enzyme levels in Responders and Non RespondersTimepoint: All at the end of the study

Secondary

MeasureTime frame
1. Quantifying Thiopurine metabolites,TPMT,IMPDH,ITPase,HGPRT enzymes using LC-MS/MSTimepoint: After the initiation of the Therapy

Countries

India

Contacts

Public ContactShailesh

Kasturba Medical College, Manipal Academy of Higher Education

cgpai@yahoo.co.in7406985507

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026