Health Condition 1: K51- Ulcerative colitis
Conditions
Interventions
Intervention1: FMT capsule: Patients with moderately active ulcerative colitis will receive FMT capsules in addition to the standard of care for induction and maintenance of remission.
The duration o
Sponsors
Vardhman Textiles Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of UC with active disease, defined as a total Mayo score of 6â??9, and a Mayo endoscopic subscore of 1 or more. 2. Any disease extent : E1, E2 or E3 3. Diagnosis (endoscopic or radiographic and histological) of UC at least 6 months prior to enrolment into the study 4. Subjects who are willing and able to comply with treatment plan, laboratory tests. 5. Subjects who are willing to provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects without previous treatment for IBD (i.e. treatment-naïve). 2. Active or latent or inadequately treated infections(includingClostridiodes difficile, Cytomegalovirus, Mycobacterium tuberculosis, etc.) 3. Subjects displaying clinical signs of fulminant colitis or toxic megacolon. 4. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses. 5. Subjects with current malignancies or a past history of malignancies. 6. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease. 7. Pregnant females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission (defined as total Mayo score â?¤2, with no individual sub-score exceeding 1 point)Timepoint: Week 8, Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response (defined as decrease in total Mayo score by at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub-score of at least 1 point or absolute rectal bleeding sub-score of 0 or 1)Timepoint: Week 8, Week 48;Endoscopic remission (defined as endoscopic Mayo sub-score of 0)Timepoint: Week 8, Week 48 | — |
Countries
India
Contacts
Public ContactAjit Sood
Dayanand Medical College and Hospital, Ludhiana
Outcome results
None listed