FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080272 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
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 ulcerative colitis on advanced therapies 
Scientific Title of Study   Efficacy of microbiome manipulation strategies fecal microbial transplant or anti-inflammatory diet or both with advanced therapies BiOlOgics and Small molecules to break the Therapeutic ceiling in active Ulcerative Colitis BOOST-UC A Multicenter Double Blind Factorial Randomized Controlled Trial 
Trial Acronym  BOOST-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 
Address  Department of Gastroenterology and Human Nutrition
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 
Address  Department of Gastroenterology and Human Nutrition
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 
Address  Department of Gastroenterology and Human Nutrition
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 PO 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 Vishal Sharma  PGIMER Chandigarh  Department of Gastroenterology PGIMER Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 		 08872813399

docvishalsharma@gmail.com 
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 and Hospital  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 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
IIIT, Delhi  Not Applicable 
Institutional 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 Kochi  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 
Intervention  Intervention 1- Fecal Microbiota Transplantation and Anti inflammatory 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 for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6.AID for 48 weeks. 7.Advanced therapy as standard dose and schedule. 
Intervention  Intervention 2-Fecal Microbiota Transplantation and sham Anti inflammatory diet/standard dietary counselling 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 for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID/Standard dietary counseling for 48 weeks. 7. Advanced therapy as standard dose and schedule 
Intervention  Intervention 3- Sham Fecal Microbiota Transplantation and Anti inflammatory diet and advanced therapy  1.Oral placebo 1 BD for 3 days before first FMT 2.Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3.Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction therapy, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. AID for 48 weeks. 7. Advanced therapy as standard dose and schedule.  
Comparator Agent  Sham Fecal microbiota transplantation and Sham Diet and advanced therapy   1.Oral placebo 1 BD for 3 days before first FMT 2. Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3. Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4. If the patient is a non-responder or has treatment failure to induction therapy, he/she will be withdrawn from the study. 5. Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID/Standard dietary counseling for 48 weeks 7. 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.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 
 
ExclusionCriteria 
Details  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 
 
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 & 48
4. Fecal microbiome & metabolite signature at baseline, week 10 & week 48
5. Dynamics of microbiome engraftment at week 10 & 48 		 10 weeks & 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)   18/02/2025 
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  

Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications. Advanced therapies, including biologics and small molecules, have significantly improved UC management by targeting specific inflammatory pathways. However, due to the multifactorial nature of UC—driven by genetic, environmental, and microbial factors—many patients do not achieve sustained remission, highlighting a therapeutic ceiling.

Gut microbial dysbiosis and immune dysregulation are central to UC pathogenesis, with diet playing a critical role in influencing the gut microbiome. While biologics and small molecules have limitations, innovative approaches like combining fecal microbiota transplantation (FMT) and dietary interventions with advanced therapies show promise. FMT restores microbial balance, modulates immunity, and reduces inflammation, while dietary modifications, such as anti-inflammatory diets, enhance FMT efficacy by creating a favorable environment for donor microbiota engraftment.The present study is designed to evaluate the efficacy of three different microbiome manipulation strategies- FMT, AID and FMT + AID in combination with advanced therapies in patients with active UC in a 2X2 factorial trial design. Patients would be randomized into four different arms: FMT, AID, FMT+AID and placebo. The advanced therapies (biologics or small molecules) would be given in all four arms as standard therapy. With this design the trial would answer two important questions: a) efficacy of combination treatment with advanced therapies and microbiome manipulation strategies in active UC, and b) comparative efficacy of different microbiome manipulation strategies.

 
Close