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

The effect of microbiome manipulation through diet and Fecal Microbial Transplant (FMT) in inducing and maintaining remission in patients with mild to moderate ulcerative colitis: open label randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15475780

Enrollment

150

Registered

2022-03-16

Start date

2019-09-11

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Mild to moderate ulcerative colitis Digestive System

Interventions

Randomization: Patients will be randomized in 1:1 ratio to FMT + diet vs standard therapy arm. The random numbers will be generated by computerized random number (The RAND corp. Inc). The randomizatio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Deep remission (endoscopic and clinical) at 8 weeks, defined clinically (SCCAI =3 points Primary outcome measures for the maintenance phase 1. Deep remission at 48 weeks 2. Maintenance of steroid free clinical remission at 48 weeks, defined as SCCAI <=2 along with no need for steroids over 48 weeks, and tapering of steroids if patients was on steroids at inclusion	—

Secondary

Measure	Time frame
1. Clinical remission defined as SCCAI =3 points at 24 weeks and 48 weeks 3. Endoscopic response at 24 weeks, defined by decline in UCEIS by 2 points 4. Maintenance of steroid free clinical response at 48 weeks defined as decline in SCCAI by >=3 points along with no need for steroids over 48 weeks, and tapering of steroids if patients was on steroids at inclusion 5. Adverse events at 12 and 48 weeks	—

Measure

Time frame

1. Clinical remission defined as SCCAI =3 points at 24 weeks and 48 weeks 3. Endoscopic response at 24 weeks, defined by decline in UCEIS by 2 points 4. Maintenance of steroid free clinical response at 48 weeks defined as decline in SCCAI by >=3 points along with no need for steroids over 48 weeks, and tapering of steroids if patients was on steroids at inclusion 5. Adverse events at 12 and 48 weeks

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Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026