| CTRI Number |
CTRI/2026/03/106371 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Faecal Microbiota Transplantation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
esting Whether Healthy Gut Bacteria Transfer Can Improve Blood Sugar Control and Immunity in Type 1 Diabetes |
|
Scientific Title of Study
|
Investigating the Role of Fecal Microbiota Transplantation in Immune and Metabolic Alterations in Type 1 Diabetes: A Randomized Control 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 |
Priyam Batra |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Microbiology, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
7065226016 |
| Fax |
|
| Email |
dr.priyambatra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyam Batra |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Microbiology, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
7065226016 |
| Fax |
|
| Email |
dr.priyambatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyam Batra |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Microbiology, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
7065226016 |
| Fax |
|
| Email |
dr.priyambatra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Microbiology and Department of Endocrinology, Metabolism & Diabetes, All India Institute of Medical Sciences, New Delhi-110029 |
| ICMR New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research Delhi |
| Address |
Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyam Batra |
AIIMS, New Delhi |
Department of Microbiology, AIIMS, New Delhi
South West
DELHI |
7065226016
dr.priyambatra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
as control group |
| Patients |
(1) ICD-10 Condition: E108||Type 1 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Allogenic Fecal Microbiota Transplantation |
FMT is delivered via colonoscopy into the caecum or terminal ileum. In this study, two sessions (as per protocol) will be planned. |
| Comparator Agent |
Autologous Feacal Microbiota Transplantation |
patient’s own baseline stool will be delivered via colonoscopy into the caecum or terminal ileum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with T1D duration less than 5 years with detectable C-peptide level
No antibiotic use in the last 3 months
No history of gastrointestinal diseases or recent infections
|
|
| ExclusionCriteria |
| Details |
Inability to provide written informed consent
Evidence for absent residual beta cell function undetectable C-peptide
Antibiotics use in the last 3 months and proton pump inhibitor use
Presence of other autoimmune disorders
Use of immunosuppressive medications
Pregnancy or with a pregnancy plan
Severe diabetic complications or active infections
severe organ dysfunction (including decompensated cirrhosis, malignant tumors etc.)
History of any probiotic supplement drug and no history of any probiotic supplement drug intake in last 8 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in gut microbial and metabolites composition from baseline to 12 months post-FMT (including microbial diversity indices and relative abundance of key taxa). |
Baseline, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in frequency of regulatory T cells (CD4+CD25+FoxP3+) and level of pro and anti-inflammatory markers from baseline to 12 months post-FMT |
Baseline, 3 months, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the impact of faecal microbiota transplantation on gut microbial diversity, microbial metabolites, immune modulation, and glycemic control in patients with Type 1 Diabetes. Participants with recent-onset T1D (less than or equal to 5 years, with detectable C-peptide) will be randomized to receive either allogenic FMT (from healthy donors) or autologous FMT (own stool). The intervention will be followed over 12 months. Key endpoints include changes in gut microbiota composition, stool short-chain fatty acids (SCFAs), frequency of regulatory T cells, cytokine levels, HbA1c, and C-peptide. The study will use multi-omics integration of microbiome, metabolomics, and immunological data to understand how FMT can potentially preserve beta-cell function and modulate autoimmune progression in T1D. This is the first trial in India to explore immunological endpoints of FMT in T1D. |