A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis
NCT ID: NCT06895252
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2025-03-15
2028-03-15
Brief Summary
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\+ 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.
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Detailed Description
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FMT + Anti-inflammatory Diet (AID) + 5-ASA (Group A) FMT + Sham Diet + 5-ASA (Group B) Sham Transplantation + AID + 5-ASA (Group C) Sham Transplantation + Sham Diet + 5-ASA (Group D) All groups receive 5-aminosalicylic acid (5-ASA) as the standard medical therapy.
Study Setting
The trial is conducted at six FMT centers across India, with one additional center dedicated to microbiome analysis:
AIIMS, New Delhi, India Dayanand Medical College, Ludhiana, India PGIMER, Chandigarh, India Lisie Hospital, Kochi, India IMS, BHU, Varanasi, India Lokmanya Tilak Municipal Medical College, Mumbai, India IIIT-Delhi, India (for microbiome analysis)
Intervention Details Fecal Microbiota Transplantation (FMT) Patients receive three FMT sessions (weeks 0, 2, 6) during induction and additional 8-weekly maintenance sessions (weeks 10, 18, 26, 34, 42) for responders.
FMT is delivered via colonoscopy; at week 0, it is instilled into the right colon/terminal ileum (post bowel preparation), while for maintenance sessions, it is instilled in the left colon without bowel preparation.
Each FMT dose is 50 g stool, freshly prepared within 4 hours of collection. Multiple donors are used to ensure microbiome diversity
Anti-Inflammatory Diet (AID) Patients assigned to AID receive a nutritionally tailored diet that promotes T-regulatory cell expansion, microbiome stability, and gut barrier integrity.
The diet excludes gluten-based grains, dairy products, and pro-inflammatory foods while including fermented foods, cruciferous vegetables, and polyphenols.
Patients are provided diet charts, receive dietary counseling, and are monitored via diet app named IBDNutricare.
Sham Interventions Sham FMT: Instead of donor stool, patients receive sterile water infusions via colonoscopy at the same time points as FMT.
Sham Diet: Patients receive dietary counselling without specific modifications
Randomization and Blinding Central randomization is conducted via REDCap. Block randomization will be done in which blocks of 8 will be created for the randomization. Further, stratified randomization will also be done in which \<25% Proctitis involving Ulcerative Colitis patients.
Blinding:
Patients, investigators collecting clinical data, and those assessing endoscopic images are blinded. The endoscopist administering FMT and the dietitian providing dietary counseling are unblinded
Data Collection and Assessments Baseline Assessments (Week 0) Clinical Evaluation: Patient-reported outcomes (PRO-2), stool frequency, rectal bleeding assessments.
Laboratory Tests: Hemogram, renal/liver function, CRP, ESR, fecal calprotectin, and microbiome profiling.
Endoscopy: Mayo Endoscopic Score (MES) assessment with high-definition recordings.
Histology: Biopsy samples assessed using Robarts Histologic Index (RHI) and Distribution Chronicity and Activity (DCA) score
Follow-up Assessments Week 10 (Induction phase endpoint): Endoscopy, histology, laboratory tests. Week 48 (Maintenance phase endpoint): Same assessments as baseline. Microbiome Analysis: Fecal samples collected at baseline, 10 weeks, and 48 weeks for metagenomics and metabolomics
Safety Monitoring Adverse events graded using CTCAE criteria (Grade 1-5). Serious adverse events (SAEs) include hospitalization, disability, or life-threatening conditions
Data Management Data is collected using paper Case Report Forms (CRF's) and then data will be entered in REDCap.
Endoscopic images and videos are securely stored and centrally reviewed.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Sham transplantation with sham diet
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
Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Sham diet
Dietary counselling alone
Fecal Microbiota Transplant(FMT) and Sham diet
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
Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Sham diet
Dietary counselling alone
Anti-inflammatory diet and sham transplantation
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
Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Anti inflammatory diet
The modified diet plan will be given to each study participant
Fecal Microbiota Transplant(FMT) and Anti inflammatory diet
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
Anti inflammatory diet
The modified diet plan will be given to each study participant
Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Interventions
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Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Anti inflammatory diet
The modified diet plan will be given to each study participant
Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Sham diet
Dietary counselling alone
Eligibility Criteria
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Inclusion Criteria
2. Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).
3. Aged between 18-75 years.
4. Patients giving consent for FMT.
5. Patients who agree to adhere to the diet schedule.
6. Patients on oral or topical ASA for less than 4 weeks.
7. Patients on oral steroids/ topical steroids for less than 1 week.
8. 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.
Exclusion Criteria
2. Clinical signs of fulminant colitis or toxic megacolon
3. Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.
4. Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than 2 weeks
5. Patients requiring hospitalization
6. Pregnant or lactating women
7. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
8. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
9. 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.
18 Years
75 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Institute of Medical Sciences of the Banaras Hindu University, India
OTHER
Dayanand Medical College and Hospital
OTHER
Indraprastha Institute of Information Technology Delhi
OTHER
Lisie Hospital
OTHER
Indian Council of Medical Research
OTHER_GOV
Lokmanya Tilak Municipal Medical College and Hospital
OTHER
All India Institute of Medical Sciences
OTHER
Responsible Party
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Prof. Vineet Ahuja
Professor
Locations
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Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh, Punjab/Haryana, India
Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University
Varanasi, Uttar Pradesh, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EMDR/CARE/12/2023-0000572
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AIIMSA2990/03.01.2025
Identifier Type: -
Identifier Source: org_study_id
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