Crohns DiseaseBOOST-CDNCT06890637
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies
A study testing Fecal Microbial Transplantation, Crohns Disease Exclusion Diet and Advanced therapy in people with Crohns Disease, run by All India Institute of Medical Sciences at 6 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohns Disease
- What is being tested?
- Fecal Microbial Transplantation, Crohns Disease Exclusion Diet and Advanced therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 6 sitesIndia
- Study dates
- 15 Mar 2025to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active Crohn disease in whom FMT is feasible
- Active Crohn's disease who are candidates for advanced therapy (steroid refractory, Immunomodulator intolerant or refractory and moderately severe disease at the time of inclusion) or patients who have an intolerance to or have lost response to advanced therapies must have had their last treatment at least five half-lives prior randomization.
- Aged between 18-75 years
- CDAI greater than 150 and/or SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)
Who cannot join
- Patients in remission (CDAI less than 150)
- Stricturing disease (non-passable stricture) in whom FMT is not feasible
- Fistulising phenotype or Perianal fistula or abscess
- Isolated L4 disease
- Active TB or Sepsis
- Pregnant or lactating women
Show all 13Show fewer
- Patients with co-morbidities like CAD/CLD/CKD
- Previous surgery for CD
- Declining consent or not willing for FMT or diet advice
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites, 6 recruiting
- Not yet recruiting
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh
Dr Vishal Sharma, DM Gasteroentrology, +91-8872813399, docvishalsharma@gmail.com
Dr Vishal Sharma, DM Gastroenterology
- Not yet recruiting
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala
Dr Mathew Philip, DM Gastroenterology, +91-9846045469, drmathewphilip@gmail.com
Dr Kiran Josy, DM Gastroenterology, +91-9745243939, drkiranjosy@gmail.com
- Not yet recruiting
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab
Prof Ajit Sood, DM Gastroenterology, +91-9815400718, ajitsood10@gmail.com
Dr Arshdeep Singh, DM Gastroenterology, +91-9815337764, drarshdeepsingh@gmail.com
- Not yet recruiting
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra
Dr Sanjay Chandnani, DM Gastroenterology, +91-9049708800, sanjy.med@gmail.com
Dr Sanjay Chandnani, DM Gastroenterology
- Recruiting
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi
Prof Vineet Ahuja, DM Gasteroentrology, +91-9810707170, vineet.aiims@gmail.com
Dr Himanshu Narang, DM Gastroentrology, +91-8800316504, h92narang@gmail.com
- Not yet recruiting
Department of Gastroenterology, Institute of Medical Sciences
Varanasi, Uttar Pradesh
Dr Devesh Prakash Yadav, DM Gastroenterology, +91-8130856563, devesh.thedoc@gmail.com
Dr Devesh Prakash Yadav, DM Gastroenterology
About this study
Official title: 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 (BOOST-CD): A Multicenter Double Blind Factorial Randomized Controlled Trial
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 8. Both the patient and the investigator will be blinded to the intervention
Read the detailed description
This is a multicenter, double-blind, factorial randomized controlled trial (RCT) evaluating the efficacy of microbiome manipulation strategies in patients with active Crohn's Disease (CD) undergoing advanced therapy (biologics or small molecules). The study will be conducted across six clinical centers in India, with an additional center designated for microbiome analysis.
Randomization and Blinding:
Randomization: Centralized, computer-generated randomization using permuted blocks of 8, 12, and 16 to ensure equal distribution across intervention arms.
Stratification: Not more than 1/3rd patients should be biological therapy exposed
Blinding:
The blinded team includes patients and principal investigators. Endoscopists administering FMT/sham FMT and dietitians providing dietary counseling will be unblinded
Sham-Control Methods:
FMT Sham: Sterile clean water infusions via colonoscopy. Diet Sham: Dietary counseling without any modification
Intervention Arms:
Patients are randomized into one of four treatment groups:
FMT + CDED + Advanced Therapy (Group A) FMT + Sham Diet + Advanced Therapy (Group B) Sham FMT + CDED + Advanced Therapy (Group C) Sham FMT + Sham Diet + Advanced Therapy (Group D)
Fecal Microbiota Transplantation (FMT):
FMT Route: Administered via colonoscopy.
FMT Schedule:
Induction Phase: Weeks 0, 2, and 6. Maintenance Phase: Every 8 weeks (weeks 10, 18, 26, 34, 42) for responders.
Preparation:
Donor Selection: Multi-donor approach with prescreening FMT Processing: 50 g stool freshly prepared and instilled within 4 hours.
Delivery Locations:
Week 0 (Bowel Preparation): Right colon/terminal ileum. Weeks 2 and 6 (No Bowel Preparation): Left colon. Crohn's Disease Exclusion Diet (CDED)
Diet Structure:
Induction Phase (Weeks 0-6): Elimination of specific pro-inflammatory dietary components.
Maintenance Phase (Weeks 6-48): Gradual reintroduction of certain food groups. Monitoring: Adherence tracked using the IBD NutriCare app, diet recall logs, and DietCal software.
Sham Diet: Patients follow a standard healthy diet with general dietary counseling.
Assessments and Data Collection Baseline Assessments (Week 0) Clinical Data: Crohn's Disease Activity Index (CDAI), stool frequency, rectal bleeding, and symptom tracking.
Laboratory Tests:
Hemogram, renal/liver function tests, blood glucose. Inflammatory Markers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FCP).
Microbiome Analysis: Stool samples stored at -80°C for sequencing.
Endoscopic Evaluation:
Scoring: Simple Endoscopic Score for CD (SES-CD). Blinded Central Review: Videos assessed by two independent readers; discrepancies adjudicated by a third reader.
Histology: Biopsies analyzed using DCA score (Distribution Chronicity and Activity).
Follow-up Assessments
Visit Schedule:
Induction Phase: Weeks 2, 4, 6, and 10. Maintenance Phase: Every 8 weeks (weeks 18, 26, 34, 42, and 48). Clinical Assessments: CDAI, PRO2 symptom tracking, medication adherence checks. Endoscopy: Week 10 and Week 48; central scoring of videos. Diet Adherence: Assessed at weeks 2, 4, 6, and 10, then every 8 weeks. Microbiome Sampling: Stool samples collected at weeks 10 and 48. Safety Monitoring and Adverse Events
Adverse Event (AE) Classification:
CTCAE Grading (Grade 1-5) for treatment-related AEs. Serious Adverse Events (SAEs): Hospitalization, life-threatening events, or disability.
Safety Monitoring Plan:
Pre-procedural safety checks for each FMT session. Immediate post-FMT monitoring (48 hours). Late safety assessments (14 days post-FMT, then every visit). Unblinding Procedure: Allowed only for SAE management with DSMB approval. Data Management and Statistical Analysis
Electronic Data Capture (EDC):
Platform: REDCap database with tiered access permissions. Audit Trails: Secure logs of data entry and modification.
Dietary Data Processing:
IBD NutriCare app logs converted into macronutrient composition reports. Adherence scoring based on 80% compliance threshold.
Microbiome Data Processing:
Samples sequenced at IIIT-Delhi, analyzed for diversity indices and metabolic pathways.
Statistical Plan:
Primary Analysis: Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal Modeling: Mixed-effects models for repeated measures.
Effect Size Estimation:
Sample size: 168 patients (42 per arm).
- Conditions
- Crohns Disease
- Being tested
- Fecal Microbial Transplantation, Crohns Disease Exclusion Diet, Sham transplantation, Sham Diet, Advanced therapy
- Keywords
- Randomized Controlled Trial, Factorial Design, Fecal Microbial Transplantation, Crohns disease exclusion diet, Crohns disease, Advanced therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantationOther
This will involve colonoscopic instillation of fecal transplant
Crohns Disease Exclusion DietOther
The modified diet plan will be given to each study participant
Sham transplantationOther
Sham transplantation will involve saline infusion via colonoscopy
Sham DietOther
Dietary counselling alone
Advanced therapyOther
Advanced therapy as standard dose and schedule
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) and advanced therapy | Experimental | 1. 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 2. Crohn disease exclusion diet(CDED) throughout the study 3. Advanced therapy as standard dose and schedule Receives: Other: Fecal Microbial Transplantation; Other: Crohns Disease Exclusion Diet; Other: Advanced therapy |
| Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy | Experimental | 1. 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 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule Receives: Other: Fecal Microbial Transplantation; Other: Sham Diet; Other: Advanced therapy |
| Sham FMT with Crohns disease exclusion diet (CDED) and advanced therapy | Experimental | 1. 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 2. CDED throughout the study 3. Advanced therapy as standard dose and schedule Receives: Other: Crohns Disease Exclusion Diet; Other: Sham transplantation; Other: Advanced therapy |
| Sham Diet with Sham FMT with advance therapy | Sham comparator | 1.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 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule. Receives: Other: Sham transplantation; Other: Sham Diet; Other: Advanced therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with clinical remission and endoscopic response at week 10
Proportion of patients with clinical remission (defined as CDAI less than 150) and endoscopic response( defined decline in SES-CD by greater than 50%)
Measured: 10 weeks
Proportion of patients with clinical remission and endoscopic remission at week 10
Proportion of patients with clinical remission (defined as Crohn's disease activity index less than 150) and endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease patients less than 3)
Measured: 48 weeks
Secondary outcomes (16)
Proportion of patients with clinical response at Week 10
Proportion of patients with clinical response is defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150
Measured: 10 weeks
Proportion of patients with PRO2 Remission at Week 10
Proportion of patients with PRO2 Remission which is defined as Abdominal pain subscore of not more than 1 (on a scale of 0-3) and liquid or very soft stool (Bristol stool scale type 6 or 7) frequency subscore of not more than 3 calculated as a mean of 7 day count
Measured: 10 weeks
Proportion of patients with endoscopic response at Week 10
Proportion of patients with endoscopic response which is defined as 50% reduction from baseline on SES-CD
Measured: 10 weeks
Fecal microbiome and metabolite signature between responders and non-responders at week 10
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
Measured: 10 weeks
Proportion of patients with biomarker remission at Week 10
Proportion of patients with biomarker remission which is defined as fecal calprotectin ≤150 mcg/g
Measured: 10 weeks
Proportion of patients with adverse events at Week 10
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Measured: 10 weeks
Proportion of patients with clinical response at Week 48
Proportion of patients with clinical response is defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150
Measured: 48 weeks
Proportion of patients with PRO2 remission at Week 48
Proportion of patients with PRO2 remission is defined as Abdominal pain subscore of not more than 1 (on a scale of 0-3) and liquid or very soft stool (Bristol stool scale type 6 or 7) frequency subscore of not more than 3 calculated as a mean of 7 day count
Measured: 48 weeks
Proportion of patients with endoscopic response at Week 48
Proportion of patients with endoscopic response defined as 50% reduction from baseline on SES-CD
Measured: 48 weeks
Proportion of patients with Endoscopic remission at Week 48 weeks
Proportion of patients with Endoscopic remission defined as a SES-CD score of 2 or less
Measured: 48 weeks
Proportion of patients with corticosteroid-free clinical remission at Week 48
Proportion of patients with corticosteroid-free clinical remission is defined as the CDAI<150 with no exposure to steroids over the previous 8 weeks
Measured: 48 weeks
Fecal microbiome and metabolite signature between responders and non-responders at Week 48
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
Measured: 48 weeks
Proportion of patients with biomarker remission at Week 48
Proportion of patients with biomarker remission which is defined as fecal calprotectin ≤150 mcg/g
Measured: 48 weeks
Proportion of patients with adverse event at Week 48
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Measured: 48 weeks
Proportion of patients with adverse event at Week 6
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Measured: 6 weeks
Proportion of Patients Experiencing Adverse Events at Week 26
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start15 Mar 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Vineet Ahuja, All India Institute of Medical Sciences
- Investigators
- Prof Vineet Ahuja, DM Gastroenterology, Principal investigator, Department of Gastroenterology, AIIMS, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890637
- Sponsor's protocol ID
- AIIMSA2988/03.01.2025
- Acronym
- BOOST-CD
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (BOOST-CD): A Multicenter Double Blind Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06890637
- Acronym / sponsor ID
- BOOST-CD / AIIMSA2988/03.01.2025
- Conditions
- Crohns Disease
- Keywords
- Randomized Controlled Trial, Factorial Design, Fecal Microbial Transplantation, Crohns disease exclusion diet, Crohns disease, Advanced therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 8. Both the patient and the investigator will be blinded to the intervention
Detailed description
This is a multicenter, double-blind, factorial randomized controlled trial (RCT) evaluating the efficacy of microbiome manipulation strategies in patients with active Crohn's Disease (CD) undergoing advanced therapy (biologics or small molecules). The study will be conducted across six clinical centers in India, with an additional center designated for microbiome analysis.
Randomization and Blinding:
Randomization: Centralized, computer-generated randomization using permuted blocks of 8, 12, and 16 to ensure equal distribution across intervention arms.
Stratification: Not more than 1/3rd patients should be biological therapy exposed
Blinding:
The blinded team includes patients and principal investigators. Endoscopists administering FMT/sham FMT and dietitians providing dietary counseling will be unblinded
Sham-Control Methods:
FMT Sham: Sterile clean water infusions via colonoscopy. Diet Sham: Dietary counseling without any modification
Intervention Arms:
Patients are randomized into one of four treatment groups:
FMT + CDED + Advanced Therapy (Group A) FMT + Sham Diet + Advanced Therapy (Group B) Sham FMT + CDED + Advanced Therapy (Group C) Sham FMT + Sham Diet + Advanced Therapy (Group D)
Fecal Microbiota Transplantation (FMT):
FMT Route: Administered via colonoscopy.
FMT Schedule:
Induction Phase: Weeks 0, 2, and 6. Maintenance Phase: Every 8 weeks (weeks 10, 18, 26, 34, 42) for responders.
Preparation:
Donor Selection: Multi-donor approach with prescreening FMT Processing: 50 g stool freshly prepared and instilled within 4 hours.
Delivery Locations:
Week 0 (Bowel Preparation): Right colon/terminal ileum. Weeks 2 and 6 (No Bowel Preparation): Left colon. Crohn's Disease Exclusion Diet (CDED)
Diet Structure:
Induction Phase (Weeks 0-6): Elimination of specific pro-inflammatory dietary components.
Maintenance Phase (Weeks 6-48): Gradual reintroduction of certain food groups. Monitoring: Adherence tracked using the IBD NutriCare app, diet recall logs, and DietCal software.
Sham Diet: Patients follow a standard healthy diet with general dietary counseling.
Assessments and Data Collection Baseline Assessments (Week 0) Clinical Data: Crohn's Disease Activity Index (CDAI), stool frequency, rectal bleeding, and symptom tracking.
Laboratory Tests:
Hemogram, renal/liver function tests, blood glucose. Inflammatory Markers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FCP).
Microbiome Analysis: Stool samples stored at -80°C for sequencing.
Endoscopic Evaluation:
Scoring: Simple Endoscopic Score for CD (SES-CD). Blinded Central Review: Videos assessed by two independent readers; discrepancies adjudicated by a third reader.
Histology: Biopsies analyzed using DCA score (Distribution Chronicity and Activity).
Follow-up Assessments
Visit Schedule:
Induction Phase: Weeks 2, 4, 6, and 10. Maintenance Phase: Every 8 weeks (weeks 18, 26, 34, 42, and 48). Clinical Assessments: CDAI, PRO2 symptom tracking, medication adherence checks. Endoscopy: Week 10 and Week 48; central scoring of videos. Diet Adherence: Assessed at weeks 2, 4, 6, and 10, then every 8 weeks. Microbiome Sampling: Stool samples collected at weeks 10 and 48. Safety Monitoring and Adverse Events
Adverse Event (AE) Classification:
CTCAE Grading (Grade 1-5) for treatment-related AEs. Serious Adverse Events (SAEs): Hospitalization, life-threatening events, or disability.
Safety Monitoring Plan:
Pre-procedural safety checks for each FMT session. Immediate post-FMT monitoring (48 hours). Late safety assessments (14 days post-FMT, then every visit). Unblinding Procedure: Allowed only for SAE management with DSMB approval. Data Management and Statistical Analysis
Electronic Data Capture (EDC):
Platform: REDCap database with tiered access permissions. Audit Trails: Secure logs of data entry and modification.
Dietary Data Processing:
IBD NutriCare app logs converted into macronutrient composition reports. Adherence scoring based on 80% compliance threshold.
Microbiome Data Processing:
Samples sequenced at IIIT-Delhi, analyzed for diversity indices and metabolic pathways.
Statistical Plan:
Primary Analysis: Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal Modeling: Mixed-effects models for repeated measures.
Effect Size Estimation:
Sample size: 168 patients (42 per arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) and advanced therapy | Experimental | Other: Fecal Microbial Transplantation, Other: Crohns Disease Exclusion Diet, Other: Advanced therapy1. 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 2. Crohn disease exclusion diet(CDED) throughout the study 3. Advanced therapy as standard dose and schedule |
| Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy | Experimental | Other: Fecal Microbial Transplantation, Other: Sham Diet, Other: Advanced therapy1. 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 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule |
| Sham FMT with Crohns disease exclusion diet (CDED) and advanced therapy | Experimental | Other: Crohns Disease Exclusion Diet, Other: Sham transplantation, Other: Advanced therapy1. 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 2. CDED throughout the study 3. Advanced therapy as standard dose and schedule |
| Sham Diet with Sham FMT with advance therapy | Sham comparator | Other: Sham transplantation, Other: Sham Diet, Other: Advanced therapy1.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 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with active Crohn disease in whom FMT is feasible
- Active Crohn's disease who are candidates for advanced therapy (steroid refractory, Immunomodulator intolerant or refractory and moderately severe disease at the time of inclusion) or patients who have an intolerance to or have lost response to advanced therapies must have had their last treatment at least five half-lives prior randomization.
- Aged between 18-75 years
- CDAI greater than 150 and/or SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)
Key exclusion criteria (13 listed)
- Patients in remission (CDAI less than 150)
- Stricturing disease (non-passable stricture) in whom FMT is not feasible
- Fistulising phenotype or Perianal fistula or abscess
- Isolated L4 disease
- Active TB or Sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial TransplantationThis will involve colonoscopic instillation of fecal transplant | Other | Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy, Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) and advanced therapy |
| Crohns Disease Exclusion DietThe modified diet plan will be given to each study participant | Other | Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) and advanced therapy, Sham FMT with Crohns disease exclusion diet (CDED) and advanced therapy |
| Sham transplantationSham transplantation will involve saline infusion via colonoscopy | Other | Sham Diet with Sham FMT with advance therapy, Sham FMT with Crohns disease exclusion diet (CDED) and advanced therapy |
| Sham DietDietary counselling alone | Other | Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy, Sham Diet with Sham FMT with advance therapy |
| Advanced therapyAdvanced therapy as standard dose and schedule | Other | Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy, Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) and advanced therapy, Sham Diet with Sham FMT with advance therapy, Sham FMT with Crohns disease exclusion diet (CDED) and advanced therapy |
Primary outcome
Proportion of patients with clinical remission and endoscopic response at week 10
Time frame: 10 weeks
Proportion of patients with clinical remission (defined as CDAI less than 150) and endoscopic response( defined decline in SES-CD by greater than 50%)
Proportion of patients with clinical remission and endoscopic remission at week 10
Time frame: 48 weeks
Proportion of patients with clinical remission (defined as Crohn's disease activity index less than 150) and endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease patients less than 3)
16 secondary outcomes
Proportion of patients with clinical response at Week 10
Time frame: 10 weeks
Proportion of patients with PRO2 Remission at Week 10
Time frame: 10 weeks
Proportion of patients with endoscopic response at Week 10
Time frame: 10 weeks
Fecal microbiome and metabolite signature between responders and non-responders at week 10
Time frame: 10 weeks
Proportion of patients with biomarker remission at Week 10
Time frame: 10 weeks
Proportion of patients with adverse events at Week 10
Time frame: 10 weeks
Proportion of patients with clinical response at Week 48
Time frame: 48 weeks
Proportion of patients with PRO2 remission at Week 48
Time frame: 48 weeks
Proportion of patients with endoscopic response at Week 48
Time frame: 48 weeks
Proportion of patients with Endoscopic remission at Week 48 weeks
Time frame: 48 weeks
Proportion of patients with corticosteroid-free clinical remission at Week 48
Time frame: 48 weeks
Fecal microbiome and metabolite signature between responders and non-responders at Week 48
Time frame: 48 weeks
Proportion of patients with biomarker remission at Week 48
Time frame: 48 weeks
Proportion of patients with adverse event at Week 48
Time frame: 48 weeks
Proportion of patients with adverse event at Week 6
Time frame: 6 weeks
Proportion of Patients Experiencing Adverse Events at Week 26
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Vineet Ahuja, DM Gastroenterology principal investigator
Department of Gastroenterology, AIIMS, New Delhi
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbial Transplantation, Crohns Disease Exclusion Diet and Advanced therapy in people with Crohns Disease, run by All India Institute of Medical Sciences at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Vineet Ahuja, DM Gastroenterology (+91-9810707170, vineet.aiims@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with clinical remission and endoscopic response at week 10 (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.