A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies
NCT ID: NCT06906445
Last Updated: 2025-04-02
Study Results
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Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2025-03-15
2028-03-15
Brief Summary
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Detailed Description
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Randomization and Blinding:
Randomization: Centralized, computerized randomization is employed to ensure balanced treatment allocation. The permuted block method, along with stratification based on disease characteristics, ensures equal distribution across intervention arms Blinding: Patients, investigators collecting clinical data, and endoscopic video assessors are blinded to treatment allocation. The dietitian and endoscopist performing FMT (or sham FMT) are unblinded
Intervention Arms:
Participants are assigned to one of four treatment arms:
FMT + Anti-inflammatory Diet (AID) +Advanced therapy FMT + Sham Diet+ Advanced therapy Sham FMT + AID+ Advanced therapy Sham FMT + Sham Diet+ Advanced therapy FMT is administered via colonoscopy at 0, 2, and 6 weeks, with responders receiving maintenance doses every 8 weeks until week 48
Participant Timeline and Assessments:
Baseline Assessments: Clinical, laboratory, and endoscopic evaluations, including serological tests, inflammatory markers, and microbiome profiling.
Follow-up Schedule: Visits occur at Week 0, Week 6, Week 10, and then every 8 weeks until Week 48.
Endoscopic Monitoring: Colonoscopy is performed at baseline, Week 10, and Week 48. Centralized endoscopic video scoring ensures consistency
Data Collection and Management:
Paper CRF's and Electronic Data: The paper based CRF's will be filled first and then data will be entered into a REDCap software.
Dietary Monitoring: Participants will use the IBD NutriCare mobile application for diet tracking.
Microbiome Analysis: Fecal samples are processed and analyzed at a designated microbiome research center.
Safety Monitoring and Compliance:
Adverse Event Reporting: All safety events, including potential serious adverse events (SAEs), are logged and monitored by the Data and Safety Monitoring Board (DSMB).
Protocol Deviations: Documented and assessed for impact on trial integrity. Training and Quality Control: Regular site training ensures adherence to the protocol, and periodic audits maintain data quality
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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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
Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Anti-Inflammatory Diet
The modified diet plan will be given to each study participant
Advanced Therapy
Advanced therapy as standard dose and schedule
Fecal Microbiota Transplantation and sham 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
Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Sham Diet
Dietary counselling alone
Advanced Therapy
Advanced therapy as standard dose and schedule
Sham 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.
Anti-Inflammatory Diet
The modified diet plan will be given to each study participant
Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Advanced Therapy
Advanced therapy as standard dose and schedule
Sham 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
Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Sham Diet
Dietary counselling alone
Advanced Therapy
Advanced therapy as standard dose and schedule
Interventions
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Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Anti-Inflammatory Diet
The modified diet plan will be given to each study participant
Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Sham Diet
Dietary counselling alone
Advanced Therapy
Advanced therapy as standard dose and schedule
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Prof. Vineet Ahuja
Professor
Principal Investigators
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Prof Vineet Ahuja, DM Gastroenterology
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, AIIMS, New Delhi
Locations
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Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research,
Chandigarh, Punjab/Haryana, India
Department of Gastroenterology, Institute of Medical Sciences
Varanasi, Uttar Pradesh, India
Countries
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Central Contacts
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Facility Contacts
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Dr Mathew Philip, DM Gastroenterology
Role: primary
Other Identifiers
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EMDR/CARE/12/2023-0000572
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AIIMSA2987/03.01.2025
Identifier Type: -
Identifier Source: org_study_id
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