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A study to test the efficacy of rectal installation of faeces from healthy donors who have been screened for richness of healthy bacterial composition (enriched donors) in a patient with ulcerative colitis who have not received any treatment

Efficacy of enriched fecal microbiota transplantation in patients with treatment naïve ulcerative colitis: a randomized control trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009536
Enrollment
62
Registered
2017-08-29
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: null- Patients of ulcerative colitis aged 18 - 65 years with mild to moderate disease activity

Interventions

Intervention1: Fecal microbiota transplantation (FMT): The process will begin with a colonoscopic infusion of FMT by the investigator. For this the patient will be prepared for colonoscopy with polyet

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with mild to moderate ulcerative colitis as assessed by Mayo Score (between 4 â?? 9) of any disease extent 2. Patients who are treatment naïve 3. Patients giving consent for FMT

Exclusion criteria

Exclusion criteria: 1. Patients with severe disease activity 2. Patients requiring hospitalization 3. Patients with H/O bowel surgery 4. Patients with concomitant GI infection 5. Pregnancy 6. Patients with other comorbid illnesses

Design outcomes

Primary

MeasureTime frame
Clinical remission at 8 and 24 weeks, defined as Mayo score â?¤2 with all sub-scores â?¤1Timepoint: 8 and 24 weeks

Secondary

MeasureTime frame
â?¢ Clinical response at 8 weeks and 24 weeks, defined as reduction in Mayo score by 3 points or by 30% reduction in Mayo score from baseline. â?¢ Endoscopic remission at 8 weeks, defined as Mayo endoscopic sub score of 0 â?¢ Patient reported outcome at 8 and 24 weeks as assessed by IBD-control questionnaire â?¢ Adverse events at 8 and 24 weeks. Timepoint: 8 and 24 weeks

Countries

India

Contacts

Public ContactSaurabh Kedia

AIIMS

dr.saurabhkedia@yahoo.com9868428535

Outcome results

None listed

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