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CTRI Number  CTRI/2025/01/079676 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical
Other (Specify) [Fecal Microbiota Transplantation and Diet]  
Study Design  Randomized Factorial Trial 
Public Title of Study   A study to evaluate the effect of fecal transplant and dietary changes on disease activity in patients with newly diagnosed active ulcerative colitis. 
Scientific Title of Study   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) 
Trial Acronym  ALTER-UC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Gastroenterology and Human Nutrition
Room number 3093 Teaching block Third floor AIIMS New Delhi
South
DELHI
110029
India 
Phone  09810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Gastroenterology and Human Nutrition
Room number 3093 Teaching block Third floor AIIMS New Delhi
South
DELHI
110029
India 
Phone  09810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Gastroenterology and Human Nutrition
Room number 3093 Teaching block Third floor AIIMS New Delhi
South
DELHI
110029
India 
Phone  09810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi, DELHI, India 110029  
Dayanand Medical College and Hospital Tagore Nagar Ludhiana Punjab, India 141001 
ICMR 
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh, India 221005 
Lisie Hospital Kochi Kerala, India 682017 
Lokmanya Tilak Municipal Medical College and Lokmanya Tilak Municipal General Hospital (LTMMC & LTMGH), Sion Hospital, Mumbai, Maharashtra, India 400022 
PGIMER Sector 12 Chandigarh, Punjab, India 160012 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Ahuja  All India Institute of Medical Sciences   Department of Gastroenterology and Human Nutrition Room number 3093 Teaching block third floor AIIMS New Delhi 110029
South
DELHI 		 09810707170

vineet.aiims@gmail.com 
Dr Ajit Sood  Dayanand Medical College  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Ludhiana Punjab 141001
Ludhiana
PUNJAB 		 09815400718

ajitsood10@gmail.com 
Dr Tarini Shankar Ghosh  Indraprastha Institute of Information Technology  Department of Computational Biology IIIT Delhi Okhla Phase III New Delhi 110020
South
DELHI 		 09692810283

tarini.ghosh@iiitd.ac.in 
Dr Devesh Prakash Yadav  Institute of Medical Sciences BHU  Department of Gastroenterology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
Varanasi
UTTAR PRADESH 		 08130856563

devesh.thedoc@gmail.com 
Dr Mathew Philip  Lisie Hospital  Department of Gastroenterology Lisie Hospital Kochi Kerala 682017
Ernakulam
KERALA 		 09846045469

drmathewphilip@gmail.com 
Dr Sanjay Chandnani  LTMMC AND LTMGH  Gastroenterology Department, Lokmanya Tilak Municipal Medical College and Lokmanya Tilak Municipal General Hospital (LTMMC & LTMGH), Sion Hospital, Mumbai 400022
Mumbai
MAHARASHTRA 		 09049708800

sanjy.med@gmail.com 
Dr Vishal Sharma  PGIMER Chandigarh  Department of Gastroenterology PGIMER Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 		 08872813399

docvishalsharma@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
IIIT, Delhi  Not Applicable 
Institute Ethical Committee IMS BHU  Approved 
Institutional Ethics Committee AIIMS, New Delhi  Approved 
Institutional Ethics Committee Dayanand Medical College and Hospital Ludhiana  Approved 
INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH, PGIMER, Chandigarh  Approved 
Institutional Ethics Committee Human Research Lokmanya Tilak Muncipal Medical College And General Hospital   Approved 
Institutional Ethics Committee Lisie Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  5- amino salicylic acid (ASA) with Sham transplantation with sham diet  1.Oral placebo 1 BD for 3 days before first FMT 2.Sham transplantation with instillation of clean water at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 42 weeks 3. Sham diet for 48 weeks 4. 5-ASA for 48 weeks. 
Intervention  Intervention 1-Fecal Microbiota Transplantation (FMT) with 5- amino salicylic acid (ASA) and anti- inflammatory diet (AID)   1. Oral vancomycin 500 mg BD for 3 days before the first FMT. 2.FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks 3. Anti-inflammatory diet for 48 weeks. 4.5-ASA for 48 weeks 
Intervention  Intervention 2- Fecal microbiota transplantation(FMT) with 5- amino salicylic acid (ASA) and Sham diet   1.Oral vancomycin 500 mg BD for 3 days before the first FMT. 2.FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks 3. Sham diet for 48 weeks 4. 5-ASA for 48 weeks 
Intervention  Intervention 3- Anti-inflammatory diet with 5- amino salicylic acid (ASA) and sham transplantation   1.Oral placebo 1 BD for 3 days before first FMT 2.Sham transplantation (clean water) via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks 3. Anti-inflammatory diet for 48 weeks 4. 5-ASA for 48 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy outcome will evaluate fecal microbial transplantation or anti-inflammatory diet
or combination of both vs placebo for following time points
1. Proportion of patients having clinical remission and endoscopic response at week 10
2. Proportion of patients having clinical remission and endoscopic remission at week 48 		 10 weeks and 48 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Proportion of patients having clinical response/ remission; symptomatic response/ remission;
endoscopic response/ remission; histologic remission; biomarker remission at week 10
2.Proportion of patients having clinical response/ remission; symptomatic response/ remission;
endoscopic response/ remission; histologic remission; biomarker remission at week 48
3.Proportion of patients having adverse events at week 6, 10, 26 and 48
4.Fecal microbiome and metabolite signature between responders and non-responders at baseline, week 10 and week 48
5.Dynamics of microbiome engraftment at week 10 and 48 		 10 weeks and 48 weeks 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum, characterized by mucosal inflammation and symptoms like 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 naïve 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.
 
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