| CTRI Number |
CTRI/2026/01/101559 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Fecal Microbiota Transplant] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety And Efficacy Of Fecal Microbiota Transplant (stool transplant) In Gastrointestinal Graft versus Host Disease after an Allogeneic stem cell transplant: A Multicentric Phase 2 Single-Arm Trial In India |
|
Scientific Title of Study
|
Safety And Efficacy Of Fecal Microbiota Transplant In Gastrointestinal GVHD: A Multicentric Phase 2 Single-Arm Trial In India: SAFE-FMT Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shouriyo Ghosh |
| Designation |
Consultant, Clinical Haematology and Cellular Therapies |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Room number 112,
LDU building
Tata Medical Center
14, MAR (E-W), New Town, Kolkata
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
03366057891 |
| Fax |
|
| Email |
shouriyo.ghosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shouriyo Ghosh |
| Designation |
Consultant, Clinical Haematology and Cellular Therapies |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Room 112
LDU Building
Tata Medical Center
14, MAR (E-W), New Town, Kolkata
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
03366057891 |
| Fax |
|
| Email |
shouriyo.ghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shouriyo Ghosh |
| Designation |
Consultant, Clinical Haematology and Cellular Therapies |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Room 112
LDU Building
Tata Medical Center
14, MAR (E-W), New Town, Kolkata
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
03366057891 |
| Fax |
|
| Email |
shouriyo.ghosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, |
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sameer Melinkeri |
Deenanath Mangeshkar Hospital, Pune |
Department of Haematology
Deenanath Mangeshkar Hospital Road, near Mhatre Bridge, Vakil Nagar, Erandwane, Pune, Maharashtra 411004
Pune
MAHARASHTRA |
02040151000
docmelinkeri@yahoo.com |
| Dr Shouriyo Ghosh |
Tata Medical Center |
Room 112
LDU building
Tata Medical Center
14 MAR (E-W), New Town, Kolkata
North Twentyfour Parganas
WEST BENGAL |
03366057891
shouriyo.ghosh@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMC IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z948||Other transplanted organ and tissue status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fecal Microbiota Transplant |
1 to 3 administrations of third-party fresh stools as per protocol delivered endoscopically. This will be combined with Standard of care (SOC) treatment. Duration of intervention and follow up will be 3 months from date of inclusion into the trial |
| Comparator Agent |
Ruxolitinib alone |
This will be a matched cohort of retrospective patients who received ruxolitinib alone for the treatment of SR-GVHD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than or equal to 18 years old
Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
Classic onset Gastro-Intestinal Acute GVHD, fulfilling all the 4 requirements
Less than 100 days from allo-HSCT
GI aGVHD Grade II to IV (MAGIC Criteria)
Gut predominance, if other organs involved: MAGIC grading for lower GI GVHD must be higher than the grading of any other organ involved.
Histopathological evidence of diagnosis (probable, possible or definite evidence of gut GVHD)
iOne of the 2 following statuses:
Corticosteroid-refractory GI-aGVHD, defined as: Progression within 3 days of therapy onset with 1-2 mg/kg/day of methylprednisolone OR Failure to improve within 5-7 days of treatment initiation.
Corticosteroid-dependent GI-aGVHD, defined as: Recurrence of aGVHD activity during steroid taper
Controlled hematological malignant disease.
Signed informed and written consent by the subject or by the subject’s legally acceptable representative
Patients are able to have a minimum of 12 hours discontinuation of systemic antibiotics to perform FMT. For patients who require antibiotics, using antibiotics that have limited impact on the gut microbiota should be prioritized. The complete list of recommended and not recommended antibiotics is in Appendix 1.
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years old,
Acute GVHD occurring after Donor Lymphocyte Infusion.
Active uncontrolled infection according to the physician (except for minor infections such as skin and mucosal mycoses).
Not able to discontinue antibiotics more than 12 hours before FMT.
Known or past history of toxic megacolon, bowel obstruction or gastro-intestinal perforation, short bowel syndrome
Absolute Neutrophil Count less than 0.5x106/ml.
Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
Other ongoing interventional studies that might interfere with the current study’s primary endpoint
Evidence/risk of chronic aspiration
Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess safety of FMT as a treatment modality in adult patients developing steroid refractory or dependent acute gut GVHD |
7 days, 14 days, 28 days, 3 months from inclusion into the trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of the study cohort (FMT + ruxolitinib) in comparison to ruxolitinib alone at 28 days and 3 months after inclusion into the trial |
The secondary outcome measure will be gastrointestinal response (GI) response at 28 days after inclusion. GI response will be categorized as the sum of complete response (CR) and very good partial response (VGPR) rates. The efficacy analysis will be done by comparing this group with a matched cohort of retrospective patients from both participating centers, treated with ruxolitinib alone. |
| Overall Response |
Overall response at 3 months [Overall gut GVHD response - Sum of CR, VGPR and partial response (PR) rates] |
| Duration of response (DOR) |
End of study |
| 3. Exploratory objective: Assessment of a microbiota signature to study the impact of FMT on the reconstitution of the gut flora. This will be analyzed by next generation sequencing of the stool samples of the donor and the recipient at the following time points: prior to FMT, 7 days after each FMT procedure and at 3 months after the initial FMT procedure |
After each FMT and at 3 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 2 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - to personally contact the principal investigator
- For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Rationale/Gaps in existing knowledge: Allogeneic hematopoietic stem cell transplant (alloHSCT) is an important therapeutic modality for multiple hematologicalconditions. Gastrointestinal Graft-versus-host-disease (gut GVHD) is an important life-threatening complication leading to significant morbidity and mortality (50-60%) in patients undergoing allo-HSCT. Survival outcomes of steroid refractory gut GVHD (SR-GVHD) and steroid dependent gut GVHD (SD-GVHD) continue to be dismal (20-30%). Novelty of this study: Anecdotal reports indicate that FMT may be a potential treatment that is safe and effective in these conditions with response rates varying from 38-58%. Combination of FMT and ruxolitinib, which is the only approved second line therapy for SR-GVHD has produced overall responses of up to 71% (in a prospective single arm study). Objectives: We now aim to investigate the safety of FMT systematically in SR-GVHD and SD-GVHD, through a multicenter phase 2 open-label single-arm trial, assessing safety (primary objective) and efficacy (secondary objective) of FMT combined with ruxolitinib. Methods: Fifteen patients meeting the inclusion criteria of the study will berecruited after consenting. One to 3 administrations of third-party fresh stools as per protocol will be delivered endoscopically. This will be combined with ruxolitinib which is the standard of care (SOC) treatment. We shall also be evaluating the change in gut microbiome (exploratory outcome) before and after FMT by performing next generation sequencing on the stool samples before and after the procedure. Expected outcome: FMT is a safe modality of treatment in SR and SD gut GVHD. This study has been approved by the ICMR in the small grant category (2025) |