FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079673 [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 microbial transplant 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 Crohn disease. 
Scientific Title of Study   Efficacy of microbiome manipulation strategies (fecAL microbial Transplantation OR CDED OR both) in combination standard medical therapy for induction and maintenance of remission in mild to moderate tReatment naÃive active Crohns Disease: a multicentre double-blind factorial randomized controlled trial(ALTER-CD) 
Trial Acronym  ALTER-CD  
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 
Indian Council of Medical Research  
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 Post Box Number 4911 Ansari Nagar New Delhi 110029 India  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
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 Unit, 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 682017
Ernakulam
KERALA 		 09846045469

drmathewphilip@gmail.com 
Dr Sanjay Chandani   Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College  Department of Gastroenterology, Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion 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: K508||Crohns disease of both small andlarge intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention 1:Fecal Microbiota Transplantation(FMT) with Crohns disease exclusion diet(CDED)  1. Oral vancomycin 500 mg BD for 3 days before 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. Crohns Disease Exclusion Diet for 48 weeks 
Intervention  Intervention 2-Fecal microbiota transplantation(FMT) and Sham Diet  1. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 10 weeks and then 8 weekly during maintenance between 10 to 42 weeks 3. Diet Counselling for 48 weeks 
Intervention  Intervention 3- Crohns Disease Exclusion Diet(CDED) and sham transplantation(clean water)  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.Crohns Disease Exclusion Diet for 48 weeks 
Comparator Agent  Sham transplantation with Sham diet  1.Oral placebo 1 BD for 3 days before first sham transplantation 2. Sham colonoscopy with instillation of saline at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 48 weeks 3. Diet Counselling 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 Crohns disease accessible with ileocolonoscopy
2. Symptom onset of less than 12 months
3. Mild to moderate disease activity with endoscopically active disease
a. CDAI of greater than 150 and less than 450
b. SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
4. Aged between 18-75 years 
 
ExclusionCriteria 
Details  1.Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
2. Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate) for greater than 2 weeks
3. Biologicals or small molecule exposure
4. Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess
5. L4 disease
6. Pregnant or lactating women
7. Previous surgery for CD
8. Declining consent
9. Not willing for FMT/Dietary advise
10. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
11. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
12. 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 
1.Proportion of patients with clinical remission (CDAI less than 150) and endoscopic response(decline in SES-CD by gretaer than 50%) at 10 weeks
2.Proportion of patients with clinical remission (CDAI less than 150) and endoscopic
remission (SES-CD less than 3) at 48 weeks  		 10 weeks and 48 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1.Proportion of patients with clinical response defined as either CDAI decrease from
baseline of at least 70 points or CDAI less than 150 (10 weeks and 48 weeks)
2.Proportion of patients with PRO2 Remission: at 10 weeks and 48 weeks
3.Proportion of patients with endoscopic response defined as 50% reduction from baseline on SES-CD (10 weeks and 48 weeks)
4.Proportion of patients with Endoscopic remission: SES-CD of 2 or less (48 weeks)
5.Proportion of patients with corticosteroid-free clinical remission - those who are in
clinical remission at 48 weeks with no exposure to steroids in past 8 weeks
6.Fecal microbiome and metabolite signature between responders and non-responders at baseline, week 10 and week 48
7.Proportion of patients with biomarker remission
8.Proportion of patients with adverse events at week 6, 10, 26 and 48.  		 10 weeks and 48 weeks  
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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  

Dysbiosis can be rectified by several methods: antibiotics, prebiotics, probiotics, dietary modulation, and fecal microbiota transplantation. There has been limited success with the isolated use of antibiotics and pre/probiotics in the treatment of IBD. Among the measures of dietary manipulation, the use of exclusive enteral nutrition (EEN) has shown superior, or at least equivalent, efficacy compared with steroids in pediatric CD. Although the results in adults are not as encouraging, recent cohort studies in patients with complicated CD have shown good success rates. Definite exclusion diets that exclude pro-inflammatory dietary constituents have also been tested with good clinical efficacy in patients with CD, who even failed treatment with anti-TNF agents. Various dietary approaches, inclusive of exclusive enteral nutrition, partial enteral nutrition, and Crohn’s disease exclusion diet have been reported to be of benefit and are associated with changes in gut microbiome.

Fecal microbiota transplantation (FMT) defined as the infusion of fecal suspension from a healthy individual into the gastrointestinal tract of an individual with GI disease carries a diverse population of microbiota and their metabolites and has been tested with varying efficacy in IBD. In general, FMT has shown good success rates in randomized control trials in patients with UC who failed conventional agents. Although limited small RCTs exist in CD, cohort studies have also shown good success rates. Therefore, the use of FMT in addition to standard medical therapy, is a concept that has not been previously explored and forms the basis for the present study. Therefore, a well-powered RCT is required to resolve the role of FMT in CD.

In this study, we will recruit patients in four arms. Group A includes FMT+CDED+SMT, in Group B FMT+SMT+SHAM DIET, in Group C Sham FMT+CDED+SMT, in Group D Sham FMT+ Sham Diet+ SMT given. 168 patients will be recruited across 6 centers for around 3 years. Follow-up of the patient will be done at 0,2,6 and 10 weeks and 8 weekly up to 48 weeks.


 
Close