A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies
Not applicable · Testing Fecal Microbial Transplantation, Anti-Inflammatory Diet and Advanced Therapy · 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 Fecal Microbial Transplantation, Anti-Inflammatory Diet and Advanced Therapy as a possible treatment. Condition(s) listed: Ulcerative Colitis.
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:
- Adult (age 18 to 75 years) patients
- Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or greater than 2 documented within 3 months of randomization or mild symptoms with high…
- Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients.
Plus 6 more requirement(s). There are also 10 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 Achieving Clinical Remission and Endoscopic Response at 10 weeks (10 weeks)
In the researchers’ words
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications.
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 |
| Lead sponsor | All India Institute of Medical Sciences |
| Enrollment | 220 (estimated) |
| Start date | 2025-03-15 |
| Primary completion (est.) | 2027-03-15 |
| First posted | 2025-04-02 |
| Last updated | 2025-04-02 |
| Official title | Efficacy of Microbiome Manipulation Strategies Fecal Microbial Transplant or Anti-inflammatory Diet or Both With Advanced Therapies BiOlOgics and Small Molecules to Break the Therapeutic Ceiling in Active Ulcerative Colitis BOOST-UC A Multicenter Double Blind Factorial Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT06906445 |
Interventions
- Fecal Microbial Transplantation (Other)
This will involve colonoscopic instillation of fecal transplant - Anti-Inflammatory Diet (Other)
The modified diet plan will be given to each study participant - Sham transplantation (Other)
Sham FMT will involve saline infusion via colonoscopy - Sham Diet (Other)
Dietary counselling alone - Advanced Therapy (Other)
Advanced therapy as standard dose and schedule
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Adult (age 18 to 75 years) patients 2. Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or greater than 2 documented within 3 months of randomization or mild symptoms with high inflammatory burden or poor prognostic features). 3. Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients. 4. Patients with an inadequate response, loss of response, or intolerance to conventional therapies example, aminosalicylates, corticosteroids, immunosuppressants or advanced therapies including but not limited to anti TNF alpha agents, anti-integrins, anti IL 12 or IL 23 agents, anti IL 23 agents, JAK inhibitors, or S1P receptor modulators. The last administration of any such treatment must have occurred at least five half-lives prior to randomization. 5. Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report 6. Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call and other study procedures 7. Subjects who are willing to provide a written informed consent for FMT 8. Agree to adhere to the diet schedule 9. Infective colitis ruled out Biopsy showing crypt architecture distortion or basal plasmacytosis, OR two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity Exclusion Criteria: 1. Hospitalization of exacerbation of UC requiring intravenous corticosteroids 2. Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks. 3. Clinical signs of fulminant colitis or toxic megacolon 4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin or CMV (histology or IHC and or tissue PCR) at screening. (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.) 5. Active or inadequately treated infections, including Mycobacterium tuberculosis. 6. Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's Disease. 7. Patients infected with human immunodeficiency virus (HIV) 8. Patients with current or past history of malignancy. 9. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, Hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. 10. Pregnant females
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 | 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.