The effect of a combination of a specific diet and stool therapy (from a healthy individual) in causing improvement in patients with mild to moderate ulcerative colitis

Not Applicable

• Conditions: Mild to moderate ulcerative colitis; Digestive System

• Registration Number: ISRCTN15475780
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35973787/ (added 17/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-16
• Last Update Posted: 29 August 2022
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Age between 18 – 65 years
2. Patients with mild to moderate ulcerative colitis as assessed by simple clinical colitis activity index (SCCAI, 3 – 9) of any disease extent along with active disease on endoscopy (ulcerative colitis index of severity, UCEIS >1)
3. Patients on stable doses of 5-ASA (5-amino salicylic acid) for past 4 weeks
4. Patients on stable doses of azathioprine/6-mercaptopurine for past 3 months
5. Patients who received biologics 6 months ago
6. Patients on stable doses of topical therapy for past 2 weeks
7. Patients on oral steroids (equivalent dose of prednisolone <20 mg/day)
8. Patients giving consent for FMT
9. Patients who agree to adhere to the diet schedule

Exclusion Criteria

1. Patients with severe disease activity
2. Patients who have received topical 5-ASA or topical steroids in the past 2 weeks
3. Patients with H/O of antibiotic or probiotic exposure in the past 4 weeks
4. Patients requiring hospitalization
5. Patients with H/O bowel surgery
6. Patients with concomitant GI infection
7. Pregnancy
8. Patients with other comorbid illnesses

Study & Design

• Study Type: Interventional
• Study Design: Not specified