A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis

NCT06895252 | Recruiting DMC

• 2 other identifiers: AIIMSA2990/03.01.2025EMDR/CARE/12/2023-0000572
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 6

Brief Summary

Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum, characterized by mucosal inflammation and symptomslike diarrhea, abdominal pain, and rectal bleeding. It is a subtype of inflammatory bowel disease (IBD) and results from a combination of genetic predisposition, environmental factors, and immune dysregulation. UC is associated with significant gut microbiota dysbiosis, marked by reduced beneficial bacteria and increased harmful taxa. With rising prevalence in developing countries like India, effective and accessible treatments remain a critical need. This multi-center randomized factorial double blind placebo controlled treat through trial will utilize a 2x 2 factorial design to randomize patients of mild to moderate (modified Mayo score 3-6) endoscopically active (Mayo endoscopic score: \>1) treatment naÃive UC in 1:1:1:1 ratio to fecal microbiota transplantation (FMT) + anti-inflammatory diet (AID) +5-aminisalicylic acid (5-ASA) (Intervention, Group A) vs fecal microbiota transplantation + sham diet +5-aminisalicylic acid(Intervention, Group B) vs sham transplantation + anti-inflammatory diet +5-aminisalicylic acid(Intervention, Group C) vs sham transplantation \+ sham diet +5-aminisalicylic acid(Control, Group D). In the induction phase patients will receive FMT/sham transplantation at 0, 2 and 6 weeks along with AID/Sham diet and 5-ASA for 10 weeks. Outcome will be assessed at 10 weeks, Treatment failure will be out of trial. Patients with clinical response at 10 weeks will continue in the maintenance phase and will receive FMT/sham transplantation at 10, 18, 26, 34, and 42 weeks along with AID/Sham diet and 5-ASA till48 weeks. Outcome will be assessed at 48 weeks. Treatment failure will be out of trial. The primary efficacy outcome will evaluate fecal microbial transplantation or anti- inflammatory diet or combination of both vs placebo. The primary outcomes are proportion of patients having clinical remission and endoscopic response at week 10 and proportion of patients having clinical remission and endoscopic remission at week 48. Modified intention to treat analysis will be done and patients who receive at least 1 dose of intervention will be included for outcome assessment.

Conditions

Ulcerative Colitis (UC)

Keywords

factorial design; Randomized controlled trial; Fecal microbiota transplantation; Anti inflammatory diet; Ulcerative colitis

Outcome Measures

Primary Outcomes (2)

• Proportion of patients having clinical remission and endoscopic response at week 10

  Proportion of patients having- 1. Clinical remission which is defined as the Modified Mayo Score (mMS) \< 2 mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.) 2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.

  10 weeks

• Proportion of patients having clinical remission and endoscopic response at week 48

  Proportion of patients having- 1. Clinical remission which is defined as the Modified Mayo Score (mMS) \< 2 mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.) 2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.

  48 weeks

Secondary Outcomes (24)

• Proportion of patients having clinical response at week 10

  10 weeks

• Proportion of patients having clinical remission at week 10

  10 weeks

• Proportion of Patients achieving Symptomatic Response at Week 10

  10 weeks

• Proportion of Patients achieving Symptomatic Remission at week 10

  10 weeks

• Proportion of Patients Achieving Endoscopic Response at Week 10

  10 weeks

Study Arms (4)

Sham transplantation with sham diet

SHAM COMPARATOR

1. Oral placebo 1 BD for 3 days before first FMT 2. Sham transplantation with instillation of clean water at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 42 weeks 3. Sham diet for 48 weeks 4. 5-ASA for 48 weeks

Other: Sham transplantation; Other: Sham diet

Fecal Microbiota Transplant(FMT) and Sham diet

EXPERIMENTAL

1. Oral vancomycin 500 mg BD for 3 days before the first FMT. 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks 3. Sham diet for 48 weeks 4. 5-ASA for 48 weeks

Other: Fecal Microbial Transplantation; Other: Sham diet

Anti-inflammatory diet and sham transplantation

EXPERIMENTAL

1. Oral placebo 1 BD for 3 days before first FMT 2. Sham transplantation (clean water) via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks 3. Anti-inflammatory diet for 48 weeks 4. 5-ASA for 48 weeks

Other: Sham transplantation; Other: Anti inflammatory diet

Fecal Microbiota Transplant(FMT) and Anti inflammatory diet

EXPERIMENTAL

1. Oral vancomycin 500 mg BD for 3 days before the first FMT. 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks 3. Anti-inflammatory diet for 48 weeks 4. 5-ASA for 48 weeks

Other: Anti inflammatory diet; Other: Fecal Microbial Transplantation

Interventions

Sham transplantation OTHER

Sham FMT will involve saline infusion via colonoscopy

Anti-inflammatory diet and sham transplantation; Sham transplantation with sham diet

Anti inflammatory diet OTHER

The modified diet plan will be given to each study participant

Anti-inflammatory diet and sham transplantation; Fecal Microbiota Transplant(FMT) and Anti inflammatory diet

Fecal Microbial Transplantation OTHER

This will involve colonoscopic instillation of fecal transplant

Fecal Microbiota Transplant(FMT) and Anti inflammatory diet; Fecal Microbiota Transplant(FMT) and Sham diet

Sham diet OTHER

Dietary counselling alone

Fecal Microbiota Transplant(FMT) and Sham diet; Sham transplantation with sham diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients.
• Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).
• Aged between 18-75 years.
• Patients giving consent for FMT.
• Patients who agree to adhere to the diet schedule.
• Patients on oral or topical ASA for less than 4 weeks.
• Patients on oral steroids/ topical steroids for less than 1 week.
• Infective colitis should be ruled out by histologic appearance of crypt architecture distortion/basal plasmacytosis, or two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity.

You may not qualify if:

• Patients with severe disease (mMS equal to 7-9)
• Clinical signs of fulminant colitis or toxic megacolon
• Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.
• Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than 2 weeks
• Patients requiring hospitalization
• Pregnant or lactating women
• Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
• Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
• Patients infected with human immunodeficiency virus (HIV) # The patients with positive assay will be treated appropriately and tests will be repeated. Those with negative assay and persistent activity will be included in the study.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• Institute of Medical Sciences of the Banaras Hindu University, India: collaborator
• Dayanand Medical College and Hospital: collaborator
• Indraprastha Institute of Information Technology Delhi: collaborator
• Lisie Hospital: collaborator
• Indian Council of Medical Research: collaborator
• Lokmanya Tilak Municipal Medical College and Hospital: collaborator

Study Sites (6)

Department of Gastroenterology, Lisie Hospital

Kochi, Kerala, India

NOT YET RECRUITING

Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion

Mumbai, Maharashtra, India

NOT YET RECRUITING

Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Department of Gastroenterology, Dayanand Medical College

Ludhiana, Punjab, India

NOT YET RECRUITING

Department of Gastroentrology, Postgraduate Institute of Medical Education and Research

Chandigarh, Punjab/Haryana, India

NOT YET RECRUITING

Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University

Varanasi, Uttar Pradesh, India

NOT YET RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Prof Vineet Ahuja, DM Gastroenterology

CONTACT

+91-9810707170; vineet.aiims@gmail.com

Dr Himanshu Narang, DM Gastroenterology

CONTACT

+91-8800316504; h92narang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 26, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2028
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)