A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis (ALTER-UC)

April 1, 2025 updated by: Prof. Vineet Ahuja, All India Institute of Medical Sciences, New Delhi

Efficacy of Microbiome Manipulation Strategies (fecAL Microbial Transplantation OR Anti-inflammatory diEt OR Both) in Combination With 5-aminosalicylic Acid for Induction and Maintenance of Remission in Patients With Mild to Moderate tReatment Naive Active Ulcerative Colitis: a Multicentre Double-blind Factorial Randomized Controlled Trial(ALTER-UC)

Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum, characterized by mucosal inflammation and symptomslike diarrhea, abdominal pain, and rectal bleeding. It is a subtype of inflammatory bowel disease (IBD) and results from a combination of genetic predisposition, environmental factors, and immune dysregulation. UC is associated with significant gut microbiota dysbiosis, marked by reduced beneficial bacteria and increased harmful taxa. With rising prevalence in developing countries like India, effective and accessible treatments remain a critical need. This multi-center randomized factorial double blind placebo controlled treat through trial will utilize a 2x 2 factorial design to randomize patients of mild to moderate (modified Mayo score 3-6) endoscopically active (Mayo endoscopic score: >1) treatment naÃive UC in 1:1:1:1 ratio to fecal microbiota transplantation (FMT) + anti-inflammatory diet (AID) +5-aminisalicylic acid (5-ASA) (Intervention, Group A) vs fecal microbiota transplantation + sham diet +5-aminisalicylic acid(Intervention, Group B) vs sham transplantation + anti-inflammatory diet +5-aminisalicylic acid(Intervention, Group C) vs sham transplantation

+ sham diet +5-aminisalicylic acid(Control, Group D). In the induction phase patients will receive FMT/sham transplantation at 0, 2 and 6 weeks along with AID/Sham diet and 5-ASA for 10 weeks. Outcome will be assessed at 10 weeks, Treatment failure will be out of trial. Patients with clinical response at 10 weeks will continue in the maintenance phase and will receive FMT/sham transplantation at 10, 18, 26, 34, and 42 weeks along with AID/Sham diet and 5-ASA till48 weeks. Outcome will be assessed at 48 weeks. Treatment failure will be out of trial. The primary efficacy outcome will evaluate fecal microbial transplantation or anti- inflammatory diet or combination of both vs placebo. The primary outcomes are proportion of patients having clinical remission and endoscopic response at week 10 and proportion of patients having clinical remission and endoscopic remission at week 48. Modified intention to treat analysis will be done and patients who receive at least 1 dose of intervention will be included for outcome assessment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center, double-blind, 2 × 2 factorial, randomized sham-controlled trial designed to evaluate the effects of fecal microbiota transplantation (FMT) and dietary modification in treatment-naïve patients with mild to moderate active ulcerative colitis (UC). The trial consists of four treatment arms:

FMT + Anti-inflammatory Diet (AID) + 5-ASA (Group A) FMT + Sham Diet + 5-ASA (Group B) Sham Transplantation + AID + 5-ASA (Group C) Sham Transplantation + Sham Diet + 5-ASA (Group D) All groups receive 5-aminosalicylic acid (5-ASA) as the standard medical therapy.

Study Setting

The trial is conducted at six FMT centers across India, with one additional center dedicated to microbiome analysis:

AIIMS, New Delhi, India Dayanand Medical College, Ludhiana, India PGIMER, Chandigarh, India Lisie Hospital, Kochi, India IMS, BHU, Varanasi, India Lokmanya Tilak Municipal Medical College, Mumbai, India IIIT-Delhi, India (for microbiome analysis)

Intervention Details Fecal Microbiota Transplantation (FMT) Patients receive three FMT sessions (weeks 0, 2, 6) during induction and additional 8-weekly maintenance sessions (weeks 10, 18, 26, 34, 42) for responders.

FMT is delivered via colonoscopy; at week 0, it is instilled into the right colon/terminal ileum (post bowel preparation), while for maintenance sessions, it is instilled in the left colon without bowel preparation.

Each FMT dose is 50 g stool, freshly prepared within 4 hours of collection. Multiple donors are used to ensure microbiome diversity

Anti-Inflammatory Diet (AID) Patients assigned to AID receive a nutritionally tailored diet that promotes T-regulatory cell expansion, microbiome stability, and gut barrier integrity.

The diet excludes gluten-based grains, dairy products, and pro-inflammatory foods while including fermented foods, cruciferous vegetables, and polyphenols.

Patients are provided diet charts, receive dietary counseling, and are monitored via diet app named IBDNutricare.

Sham Interventions Sham FMT: Instead of donor stool, patients receive sterile water infusions via colonoscopy at the same time points as FMT.

Sham Diet: Patients receive dietary counselling without specific modifications

Randomization and Blinding Central randomization is conducted via REDCap. Block randomization will be done in which blocks of 8 will be created for the randomization. Further, stratified randomization will also be done in which <25% Proctitis involving Ulcerative Colitis patients.

Blinding:

Patients, investigators collecting clinical data, and those assessing endoscopic images are blinded. The endoscopist administering FMT and the dietitian providing dietary counseling are unblinded

Data Collection and Assessments Baseline Assessments (Week 0) Clinical Evaluation: Patient-reported outcomes (PRO-2), stool frequency, rectal bleeding assessments.

Laboratory Tests: Hemogram, renal/liver function, CRP, ESR, fecal calprotectin, and microbiome profiling.

Endoscopy: Mayo Endoscopic Score (MES) assessment with high-definition recordings.

Histology: Biopsy samples assessed using Robarts Histologic Index (RHI) and Distribution Chronicity and Activity (DCA) score

Follow-up Assessments Week 10 (Induction phase endpoint): Endoscopy, histology, laboratory tests. Week 48 (Maintenance phase endpoint): Same assessments as baseline. Microbiome Analysis: Fecal samples collected at baseline, 10 weeks, and 48 weeks for metagenomics and metabolomics

Safety Monitoring Adverse events graded using CTCAE criteria (Grade 1-5). Serious adverse events (SAEs) include hospitalization, disability, or life-threatening conditions

Data Management Data is collected using paper Case Report Forms (CRF's) and then data will be entered in REDCap.

Endoscopic images and videos are securely stored and centrally reviewed.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr Himanshu Narang, DM Gastroenterology
  • Phone Number: +91-8800316504
  • Email: h92narang@gmail.com

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Recruiting
        • Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
        • Contact:
        • Contact:
          • Dr Himanshu Narang, DM Gastroentrology
          • Phone Number: +91-8800316504
          • Email: h92narang@gmail.com
        • Contact:
          • Prof Vineet Ahuja, DM Gastroenterology
        • Contact:
          • Prof Govind Makharia, DM Gastroenterology
        • Contact:
          • Dr Purva Mathur, MD Microbiology
        • Contact:
          • Dr Prasenjit Das, MD Pathology
    • Kerala
      • Kochi, Kerala, India
        • Not yet recruiting
        • Department of Gastroenterology, Lisie Hospital
        • Contact:
        • Contact:
        • Contact:
          • Dr Mathew Philip, DM Gastroenterology
        • Contact:
          • Dr Kiran Josy, DM Gastroenterology
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Not yet recruiting
        • Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
        • Contact:
          • Dr Sanjay Chandnani, DM Gasteroentrology
          • Phone Number: +91-9049708800
          • Email: sanjy.med@gmail.com
        • Contact:
          • Dr Sanjay Chandnani, DM Gastroenterology
    • Punjab
      • Ludhiana, Punjab, India
        • Not yet recruiting
        • Department of Gastroenterology, Dayanand Medical College
        • Contact:
        • Contact:
        • Contact:
          • Prof Ajit Sood, DM Gastroenterology
        • Contact:
          • Dr Arshdeep Singh, DM Gastroenterology
    • Punjab/Haryana
      • Chandigarh, Punjab/Haryana, India
        • Not yet recruiting
        • Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
        • Contact:
        • Contact:
          • Dr Vishal Sharma, DM Gastroenterology
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India
        • Not yet recruiting
        • Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University
        • Contact:
        • Contact:
          • Dr Devesh Prakash Yadav, DM Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients.
  2. Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).
  3. Aged between 18-75 years.
  4. Patients giving consent for FMT.
  5. Patients who agree to adhere to the diet schedule.
  6. Patients on oral or topical ASA for less than 4 weeks.
  7. Patients on oral steroids/ topical steroids for less than 1 week.
  8. Infective colitis should be ruled out by histologic appearance of crypt architecture distortion/basal plasmacytosis, or two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity.

Exclusion Criteria:

  1. Patients with severe disease (mMS equal to 7-9)
  2. Clinical signs of fulminant colitis or toxic megacolon
  3. Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.
  4. Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than 2 weeks
  5. Patients requiring hospitalization
  6. Pregnant or lactating women
  7. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
  8. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
  9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham transplantation with sham diet
  1. Oral placebo 1 BD for 3 days before first FMT
  2. Sham transplantation with instillation of clean water at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 42 weeks
  3. Sham diet for 48 weeks 4. 5-ASA for 48 weeks
Other: Sham diet
Dietary counselling alone
Other: Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Experimental: Fecal Microbiota Transplant(FMT) and Sham diet
  1. Oral vancomycin 500 mg BD for 3 days before the 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. Sham diet for 48 weeks 4. 5-ASA for 48 weeks
Other: Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Other: Sham diet
Dietary counselling alone
Experimental: Anti-inflammatory diet and sham transplantation
  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. Anti-inflammatory diet for 48 weeks 4. 5-ASA for 48 weeks
Other: Sham transplantation
Sham FMT will involve saline infusion via colonoscopy
Other: Anti inflammatory diet
The modified diet plan will be given to each study participant
Experimental: Fecal Microbiota Transplant(FMT) and Anti inflammatory diet
  1. Oral vancomycin 500 mg BD for 3 days before the 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. Anti-inflammatory diet for 48 weeks
  4. 5-ASA for 48 weeks
Other: Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Other: Anti inflammatory diet
The modified diet plan will be given to each study participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients having clinical remission and endoscopic response at week 10
Time Frame: 10 weeks

Proportion of patients having-

  1. Clinical remission which is defined as the Modified Mayo Score (mMS) < 2 mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
  2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
10 weeks
Proportion of patients having clinical remission and endoscopic response at week 48
Time Frame: 48 weeks

Proportion of patients having-

  1. Clinical remission which is defined as the Modified Mayo Score (mMS) < 2 mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
  2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients having clinical response at week 10
Time Frame: 10 weeks
Proportion of patients having clinical response (Defined as a decrease from baseline in the mMS of greater than or equal to 2 points and at least a 30 percent reduction from baseline) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
10 weeks
Proportion of patients having clinical remission at week 10
Time Frame: 10 weeks
Proportion of patients having clinical remission which is defined as an mMS of 0 to 2, including the following three components: 1) Stool frequency sub score = 0 (or = 1 with a ≥ 1-point decrease from baseline), 2) Rectal bleeding sub score = 0 3) Centrally read endoscopy sub score = 0 or 1 (score of 1 modified to exclude friability) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
10 weeks
Proportion of Patients achieving Symptomatic Response at Week 10
Time Frame: 10 weeks

Proportion of Patients Achieving Symptomatic Response which is defined as Decrease from baseline ≥ 30% in composite Rectal Bleeding sub score and Stool Frequency sub score and a ≥ 1-point decrease from baseline in RB sub score or an absolute RB sub score ≤ 1)

Stool Frequency Subscore:

Range: 0 to 3 (typically; the exact range may vary depending on the scale used) Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.)

Rectal Bleeding Subscore:

Range: 0 to 3 (typically; range may vary depending on the version used) Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
10 weeks
Proportion of Patients achieving Symptomatic Remission at week 10
Time Frame: 10 weeks

Proportion of Patients achieving Symptomatic Remission which is defined as Stool Frequency subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and Rectal Bleeding subscore = 0

Stool Frequency Subscore:

Range: 0 to 3 (typically; the exact range may vary depending on the scale used) Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.)

Rectal Bleeding Subscore:

Range: 0 to 3 (typically; range may vary depending on the version used) Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
10 weeks
Proportion of Patients Achieving Endoscopic Response at Week 10
Time Frame: 10 weeks
Proportion of Patients Achieving Endoscopic Response which is defined as decrease in Modified Endoscopic Score ≥1 points MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
10 weeks
Proportion of Patients Achieving Endoscopic Remission at Week 10
Time Frame: 10 weeks
Proportion of Patients achieving Endoscopic Remission which is defined as Modified Endoscopy Score=0 MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
10 weeks
Proportion of Patients Achieving Histologic Remission at Week 10
Time Frame: 10 weeks

Proportion of Patients Achieving Histologic Remission (Robarts histopathology index score <3 with lamina propria neutrophils score = 0 and neutrophil in epithelium score=0; DCA (Distribution/ chronicity/ activity) score, A=0)

Robarts Histopathology Index (RHI):

Full Title: Robarts Histopathology Index Range: 0 to 16 (varies depending on the specific version used, but typically it is in this range) Lower Scores = Better Outcome (A lower score indicates less histologic damage or inflammation.)

Lamina Propria Neutrophils Score:

Range: 0 to 3 Lower Scores = Better Outcome (A score of 0 indicates no neutrophils present, which is a sign of histologic remission.)

Neutrophils in Epithelium Score:

Range: 0 to 3 Lower Scores = Better Outcome (A score of 0 indicates no neutrophils in the epithelium, which is also a sign of histologic remission.)

DCA Score:

Full Title: Distribution/Chronicity/Activity Score Range: 0 to 3 Lower Scores = Better Outcome (score of 0 =no activity
10 weeks
Proportion of Patients Achieving Biomarker Remission at Week 10
Time Frame: 10 weeks
Proportion of Patients Achieving Biomarker Remission (Defined as fecal calprotectin ≤150 mcg/g)
10 weeks
Proportion of Patients Experiencing Adverse Events at Week 10
Time Frame: 10 weeks
Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows: Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death.
10 weeks
Fecal Microbiome and Metabolite Signature at Week 10
Time Frame: 10 weeks
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
10 weeks
Dynamics of microbiome engraftment at week 10
Time Frame: 10 weeks

It involves capturing donor-to-recipient microbiome transfer/shift at species and strain-level will be performed as an investigation of 'FMT events', where in each event will include triad of samples: the donor, the Pre-FMT and the Post-FMT sample from the recipient patient. Species-level donor-to-recipient shifts will be investigated by computing the Bray-Curtis and Kendall distances between all three sample-pairs of the triad.

Kendall distances capture the variations and similarities amongst samples in terms of the relative hierarchical ranking of different taxa within a community, Bray-Curtis distances capture the differences in the abundances of different taxa across two communities. Both these distance measure-based approaches will be utilized the fraction of recipient microbiome that is modulated by the donor microbiome in terms of both composition and species-level hierarchy.
10 weeks
Proportion of patients having clinical response at week 48
Time Frame: 48 weeks
Proportion of patients having clinical response (Defined as a decrease from baseline in the mMS of greater than or equal to 2 points and at least a 30 percent reduction from baseline) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
48 weeks
Proportion of patients having clinical remission at week 48
Time Frame: 48 weeks
Proportion of patients having clinical remission which is defined as an modified mayo score of 0 to 2, including the following three components: 1) Stool frequency sub score = 0 (or = 1 with a ≥ 1-point decrease from baseline), 2) Rectal bleeding sub score = 0 3) Centrally read endoscopy sub score = 0 or 1 (score of 1 modified to exclude friability) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
48 weeks
Proportion of Patients Achieving Symptomatic Response at Week 48
Time Frame: 48 weeks
Proportion of Patients Achieving Symptomatic Response which is defined as Decrease from baseline ≥ 30% in composite Rectal Bleeding sub score and Stool Frequency sub score and a ≥ 1-point decrease from baseline in RB sub score or an absolute RB sub score ≤ 1) Stool Frequency Subscore: Range: 0 to 3 (typically; the exact range may vary depending on the scale used) Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.) Rectal Bleeding Subscore: Range: 0 to 3 (typically; range may vary depending on the version used) Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
48 weeks
Proportion of Patients achieving Symptomatic Remission at Week 48
Time Frame: 48 weeks
Proportion of Patients achieving Symptomatic Remission which is defined as Stool Frequency subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and Rectal Bleeding subscore = 0 Stool Frequency Subscore: Range: 0 to 3 (typically; the exact range may vary depending on the scale used) Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.) Rectal Bleeding Subscore: Range: 0 to 3 (typically; range may vary depending on the version used) Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
48 weeks
Proportion of Patients achieving Endoscopic Response at Week 48
Time Frame: 48 weeks
Proportion of Patients Achieving Endoscopic Response which is defined as decrease in Modified Endoscopic Score ≥1 points MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
48 weeks
Proportion of Patients achieving Endoscopic Remission at Week 48
Time Frame: 48 weeks
Proportion of Patients achieving Endoscopic Remission which is defined as Modified Endoscopy Score=0 MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
48 weeks
Proportion of Patients achieving Histologic Remission at Week 48
Time Frame: 48 weeks
Proportion of Patients Achieving Histologic Remission (Robarts histopathology index score <3 with lamina propria neutrophils score = 0 and neutrophil in epithelium score=0; DCA (Distribution/ chronicity/ activity) score, A=0)
48 weeks
Proportion of Patients Achieving Biomarker Remission at Week 48
Time Frame: 48 weeks
Proportion of Patients Achieving Biomarker Remission (Defined as fecal calprotectin ≤150 mcg/g)
48 weeks
Fecal Microbiome and Metabolite Signature at Week 48
Time Frame: 48 weeks
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
48 weeks
Dynamics of microbiome engraftment at week 48
Time Frame: 48 weeks

It involves capturing donor-to-recipient microbiome transfer/shift at species and strain-level will be performed as an investigation of 'FMT events', where in each event will include triad of samples: the donor, the Pre-FMT and the Post-FMT sample from the recipient patient. Species-level donor-to-recipient shifts will be investigated by computing the Bray-Curtis and Kendall distances between all three sample-pairs of the triad.

Kendall distances capture the variations and similarities amongst samples in terms of the relative hierarchical ranking of different taxa within a community, Bray-Curtis distances capture the differences in the abundances of different taxa across two communities. Both these distance measure-based approaches will be utilized the fraction of recipient microbiome that is modulated by the donor microbiome in terms of both composition and species-level hierarchy.
48 weeks
Proportion of Patients Experiencing Adverse Events at Week 48
Time Frame: 48 weeks
Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows: Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death
48 weeks
Proportion of patients having adverse events at week 6
Time Frame: 6 weeks

Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows:

Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death.
6 weeks
Proportion of patients having adverse events at week 26
Time Frame: 26 weeks
Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows: Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Collaborators

Indian Council of Medical Research
Lokmanya Tilak Municipal Medical College and Hospital
Dayanand Medical College and Hospital
Post Graduate Institute of Medical Education and Research, Chandigarh
Institute of Medical Sciences of the Banaras Hindu University (BHU),India
Indraprastha Institute of Information Technology Delhi
Lisie Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2028

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIIMSA2990/03.01.2025
  • EMDR/CARE/12/2023-0000572 (Other Grant/Funding Number: Indian Council of Medical Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis (UC)

Clinical Trials on Fecal Microbial Transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe