Evaluating fecal transplant and diet changes for ulcerative colitis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of fecal microbiota transplantation (FMT) combined with dietary changes on disease activity in patients with ulcerative colitis (UC) who are on advanced therapies. It employs a multicenter, randomized, factorial-design approach, where participants are assigned to one of four treatment arms involving FMT and anti-inflammatory diets. The study includes comprehensive assessments of clinical, laboratory, and endoscopic evaluations, with follow-up visits scheduled at specific intervals to monitor progress. The aim is to explore innovative treatment combinations to improve patient outcomes in managing UC.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
  New Delhi, National Capital Territory of Delhi, India Recruiting
• 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, 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

Study contacts

• Principal investigator: Prof Vineet Ahuja, DM Gastroenterology — Department of Gastroenterology, AIIMS, New Delhi
• Study coordinator: Prof Vineet Ahuja, DM Gastroenterology
• Email: vineet.aiims@gmail.com
• Phone: +91-9810707170

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.