Evaluating fecal transplant and diet changes for ulcerative colitis
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)
This study is testing whether a combination of fecal transplants and an anti-inflammatory diet can help people with newly diagnosed active ulcerative colitis feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 6 sites (Kochi, Kerala and 5 other locations) |
| Trial ID | NCT06895252 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of fecal microbiota transplantation (FMT) combined with an anti-inflammatory diet on patients with newly diagnosed active ulcerative colitis (UC). It employs a multi-center, double-blind, 2x2 factorial design to randomize treatment-naïve patients into four groups, each receiving different combinations of FMT, dietary interventions, and standard medication (5-ASA). The study aims to assess the impact of these interventions on disease activity and gut microbiota composition. Participants will receive FMT through colonoscopy and follow a specific dietary regimen over several weeks.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve adults aged 18-75 with mild to moderate active ulcerative colitis.
Not a fit: Patients with severe ulcerative colitis or other forms of colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with ulcerative colitis, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with fecal microbiota transplantation for various gastrointestinal conditions, suggesting potential success for this approach in ulcerative colitis.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kochi, Kerala and 5 other locations
- 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)
Study contacts
- Study coordinator: Prof Vineet Ahuja, DM Gastroenterology
- Email: vineet.aiims@gmail.com
- Phone: +91-9810707170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.