UCRecruiting
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis
Not applicable · Testing Anti inflammatory diet and Fecal Microbial Transplantation · 6 sites · All India Institute of Medical Sciences
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Anti inflammatory diet and Fecal Microbial Transplantation as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 5 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 220 participants are expected to take part.
- Start date: 2025-03-15.
- Main results expected around 2027-03-15 (estimate from the record).
- 6 study sites listed (1 marked recruiting) in India.
Main thing being measured
- Proportion of patients having clinical remission and endoscopic response at week 10 (10 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | All India Institute of Medical Sciences |
| Collaborators | Post Graduate Institute of Medical Education and Research, Chandigarh; Institute of Medical Sciences of the Banaras Hindu University, India; Dayanand Medical College and Hospital; Indraprastha Institute of Information Technology Delhi; Lisie Hospital; Indian Council of Medical Research; Lokmanya Tilak Municipal Medical College and Hospital |
| Enrollment | 220 (estimated) |
| Start date | 2025-03-15 |
| Primary completion (est.) | 2027-03-15 |
| First posted | 2025-03-26 |
| Last updated | 2025-04-04 |
| Official title | Efficacy of Microbiome Manipulation Strategies (fecAL Microbial Transplantation OR Anti-inflammatory diEt OR Both) in Combination With 5-aminosalicylic Acid for Induction and Maintenance of Remission in Patients With Mild to Moderate tReatment Naive Active Ulcerative Colitis: a Multicentre Double-blind Factorial Randomized Controlled Trial(ALTER-UC) |
| ClinicalTrials.gov ID | NCT06895252 |
Interventions
- Sham transplantation (Other)
Sham FMT will involve saline infusion via colonoscopy - Anti inflammatory diet (Other)
The modified diet plan will be given to each study participant - Fecal Microbial Transplantation (Other)
This will involve colonoscopic instillation of fecal transplant - Sham diet (Other)
Dietary counselling alone
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients. 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: 1. Patients with severe disease (mMS equal to 7-9) 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.
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 | 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.