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CTRI Number  CTRI/2025/02/079947 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
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 crohn disease on advanced therapies 
Scientific Title of Study   Efficacy of microbiome manipulation strategies (fecal microbial transplant or Crohns Disease exclusion diet or both) with Advanced therapies (BiOlOgics and Small molecules) to break the Therapeutic ceiling in active Crohns Disease: A Multicenter Double Blind Factorial Randomized Controlled Trial(BOOST-CD) 
Trial Acronym  BOOST-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 Unit
Room number 3093 Teaching block third floor AIIMS
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 Unit
Room number 3093 Teaching block third floor AIIMS
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 Unit
Room number 3093 Teaching block third floor AIIMS
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. 4911Ansari 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 South DELHI 110029 India
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  Lokmanya Tilak Municipal Medical College and Lokmanya Tilak Municipal General Hospital   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  Postgraduate Institute of Medical Education and Research  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) and advanced therapy  1. Oral vancomycin 500 mg BD for 3 days before the first FMT 2. FMT via colonoscopy at 0, 2, and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) 8 weekly during maintenance till 42 weeks 3. Crohn disease exclusion diet(CDED) throughout the study 4. Advanced therapy as standard dose and schedule 
Intervention  Intervention 2-Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy  1.Oral vancomycin 500 mg BD for 3 days before the first FMT. 2. FMT via colonoscopy at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) 8 weekly during maintenance till 42 weeks 3. Dietary counseling throughout the study 4. Advanced therapy as standard dose and schedule 
Intervention  Intervention 3-Advanced-therapy with Sham FMT and Crohns disease exclusion diet (CDED)  1.Oral placebo 1 BD for 3 days before first FMT 2. Sham FMT with instillation of clean water at 0, 2, and 6 weeks (preceded by 3 days antibiotics, only before the first procedure) followed by (if treatment responder) - 8-weekly during maintenance till 42 weeks 3. CDED throughout the study 4. Advanced therapy as standard dose and schedule 
Comparator Agent  Sham Diet with Sham FMT with advance therapy  1. Oral placebo 1 BD for 3 days before first FMT. 2.Sham FMT with instillation of clean water at 0, 2, and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) - 8-weekly during maintenance till 42 weeks 3. Dietary counseling throughout the study 4. Advanced therapy as standard dose and schedule. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients with active Crohn disease in whom FMT is feasible
2.Patients with an inadequate response, loss of response, or intolerance to conventional therapies (example, corticosteroids, immunomodulators, methotrexate) 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). The last administration of any such treatment must have occurred at least five half-lives prior to randomization
3.Aged between 18-75 years
4.CDAI greater than 150 and/or SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)  
 
ExclusionCriteria 
Details  1. Patients in remission (CDAI less than 150)
2. Stricturing disease (non-passable stricture) in whom FMT is not feasible
3. Fistulising phenotype or Perianal fistula or abscess
4. Isolated L4 disease
5. Active TB or Sepsis
6. Pregnant or lactating women
7.Patients with co-morbidities like CAD/CLD/CKD
8. Previous surgery for CD
9. Declining consent or not willing for FMT or diet advice
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 greater 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 (48 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

Exploratory endpoints
1.Histologic response at 48 weeks
 		 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)   15/02/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Advanced therapies including biologics and small molecules target specific inflammatory pathways. IBD’s multifactorial etiology means that blocking a single pathway may not be sufficient for all patients. Even when combination of advanced therapies are used, the incremental benefits often diminish, reflecting the therapeutic ceiling. Furthermore, safety concerns also limit the potential to push beyond this ceiling. Increasing the dose or adding more immunosuppressive agents can lead to a higher risk of infections, malignancies, and other adverse effects, making it impractical to continually intensify treatment.

Understanding the therapeutic ceiling in IBD highlights the need for innovative approaches that go beyond current strategies. Given the diverse microbial and immunological landscapes in IBD combining fecal microbiota transplantation (FMT) and Crohn’s Disease Exclusion Diet (CDED) with advanced therapies represents a promising approach to break the therapeutic ceiling in CD. This strategy leverages the complementary mechanisms of action of FMT/CDED and advance therapies, potentially offering a more comprehensive treatment modality that addresses the complex and multifactorial nature of IBD. FMT involves the transfer of gut microbiota from a healthy donor to a patient, aiming to restore a balanced microbial community in the intestines. This can help modulate the immune system and reduce inflammation, which are central to Crohn’s disease pathology.

This study seeks to provide evidence on whether addition of microbiota manipulation by FMT and CDED offers additional benefits when used alongside advance therapies in active CD. The findings from this RCT are expected to significantly enhance treatment strategies, ensuring that patients receive the most effective and appropriate care based on robust scientific evidence. This multi-center double blind placebo-controlled RCT will randomize patients in 1:1:1:1 ratio to FMT, CDED and advance therapy vs sham FMT with advance therapy and CDED vs FMT, Advance therapy and sham diet vs Advance therapy with sham FMT and sham diet for induction and maintenance of remission in patients of active Crohn’s disease. Randomization will be held centrally to ensure concealment of allocation. Random numbers will be generated by computerized random number schedule (The RAND), and the randomization list and numbered packing of the intervention will be prepared by a person not involved in the study. Randomization will be performed using permuted blocks of 4. Both the patient and the investigator will be blinded to the intervention.

 
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