NCT06895252: ALTER-UC

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis

Recruiting now NA Last updated 4 April 2025

What this trial tests

NA trial testing Sham transplantation in Ulcerative Colitis (UC) in 220 participants. Currently enrolling.

Timeline

15 March 2025

Primary endpoint
15 March 2027

15 March 2028

Quick facts

Lead sponsor	All India Institute of Medical Sciences
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	220
Start date	15 March 2025
Primary completion	15 March 2027
Estimated completion	15 March 2028
Sites	6 locations across India

Drugs / interventions tested

• Sham transplantation
• Anti inflammatory diet
• Fecal Microbial Transplantation — full drug profile →
• Sham diet

Conditions studied

• Ulcerative Colitis (UC) — all drugs for Ulcerative Colitis (UC) →

Sponsor

All India Institute of Medical Sciences

Who can join

Adults 18 to 75, any sex, with Ulcerative Colitis (UC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. UC is associated with significant gut microbiota dysbiosis, marked by reduced beneficial bacteria and increased harmful taxa. With rising prevalence in developing countries like India, effective and accessible treatments remain a critical need. This multi-center randomized factorial double blind placebo controlled treat through trial will utilize a 2x 2 factorial design to randomize patients of mild to moderate (modified Mayo score 3-6) endoscopically active (Mayo endoscopic score: \>1) treatment naÃive UC in 1:1:1:1 ratio to fecal microbiota transplantation (FMT) + anti-inflammatory diet (AID) +5-aminisalicylic acid (5-ASA) (Intervention, Group A) vs fecal microbiota transplantation + sham diet +5-aminisalicylic acid(Intervention, Group B) vs sham transplantation + anti-inflammatory diet +5-aminisalicylic acid(Intervention, Group C) vs sham transplantation

\+ 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.