| CTRI Number |
CTRI/2024/06/069390 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Other (Specify) [Fecal Microbiota Transplantation] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Improving Gut Health: Using Faecal Microbiota Transplantation (FMT) to Treat Digestive and Mental Health in Functional Bowel Disorder(FBD) Patients |
|
Scientific Title of Study
|
Gut-Brain-Microbiome interaction: modulation of the Gut Microbiome by Faecal Microbiota Transplantation (FMT) in patients of Functional Bowel Disorder with psychiatric comorbidity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayeeta Bhowmick |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences(AIIMS), Kalyani |
| Address |
All India Institute of Medical Sciences(AIIMS), Kalyani.
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
919432100747 |
| Fax |
|
| Email |
jayeeta.gastro@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayeeta Bhowmick |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences(AIIMS), Kalyani |
| Address |
All India Institute of Medical Sciences(AIIMS), Kalyani.
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
919432100747 |
| Fax |
|
| Email |
jayeeta.gastro@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayantan Banerjee |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences(AIIMS), Kalyani |
| Address |
All India Institute of Medical Sciences(AIIMS), Kalyani.
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
918697477033 |
| Fax |
|
| Email |
sayantan.micro@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research(ICMR), Department of Health Research (Ministry of Health and Family Welfare), Government Of India. V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Dr Jayeeta Bhowmick |
| Address |
All India Institute of Medical Sciences(AIIMS), Kalyani. NH - 34 Connector,
Basantapur, Saguna
West Bengal - 741245 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jayeeta Bhowmick |
All India Institute of Medical Sciences(AIIMS) |
AIIMS Kalyani Department of Gastroenterology, Department of Medicine, Department of Psychiatry, Endoscopy Suite , AIIMS hospital campus, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL |
9432100747
jayeeta.gastro@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fecal microbiota transplantation (FMT) in patients with Functional Bowel Disorder (FBD) with psychiatric co-moribidity. |
After obtaining written informed consent standard guidelines to include patients will be followed. Patient will be given 200-300mL of processed fecal microbiota via endoscopic or colonoscopic route. Fecal microbiota will be given 3 times at an interval of 15 days for a particular subject. |
| Comparator Agent |
Healthy control group |
After obtaining written informed consent healthy person will be included to donate their stool for gut microbiota analysis. Comparison between the gut-microbiota of Healthy controls and patients will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients more than 18 years
History of chronic gastrointestinal disorder
Associated psychiatric co-morbidity
|
|
| ExclusionCriteria |
| Details |
Patient with age less than 18 years or more than 70 years
Current, active or past inflammatory bowel disease
Refusal to give consent
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement of gut microbiota post FMT
2. Compare modulation of gut microbiota pre and post FMT by microbiome analysis.
3.Coparison of IBS-SSS, IBS-QOL and GSRS scores as well as PHQ9, BAI and MDQ scores to determine improvement. |
1. At baseline and total 12 months post FMT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Whether FMT works in IBS-D patients with psychiatric co-morbidity or not.
2. Observation & interpretation on mode of FMT to the effect.
3.Evaluation of whether there is any difference in effects of allogenic & autogenic FMT.
4.Time duration the altered gut microbiota stays healthy within recipients gut.
5.Statistical analysis will be performed using SPSS 16.0 |
1. Blood & stool monitoring after 7 days.
2. Gut microbiome monitoring after 1 month, 3 months, 6 months & 12 months.
3. Mean score improvement of IBS-SSS, IBS-QOL & GSRS scale at 3 months, 6 months & 12 months.
4. Mean score improvement of BAI, PHQ9 & MDQ scales |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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) |
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
|
Some evidence exists that Faecal Microbiota transplantation (FMT) can improve symptoms in patients with Functional Bowel Disorder (FBD) and may have some beneficial effects in patients with depression and anxiety. To the best of our knowledge, no study has investigated the effects of FMT on both enteric and psychiatric symptoms in patients with FBD and psychiatric comorbidity. Objectives- 1. To compare the pattern of gut microbiota between FBD patients with psychiatric illness and that of healthy controls. 2. To develop a Faecal Microbiota Storage and Transplantation facility and conduct transplantation from healthy controls to FBD patients with psychiatric illness. 3. To assess whether FMT from healthy donors can alleviate the enteric and psychiatric symptoms of FBD patients with psychiatric illness. 4. To determine the temporal and constitutional dynamics of the transplanted microbiota in the recipient’s gut under various conditions. Methodology- 1. We shall utilise state-of-the-art shotgun sequencing-based faecal metagenomics for assessing gut microbiota of the cases, controls and healthy donors at the baseline. 2. We shall conduct a pilot randomised controlled trial for our objectives 2 and 3 and follow up with our participants for one year. Expected Outcomes among patients of FBD with psychiatric comorbidity after FMT- 1. Significant and sustained improvement of symptoms related to FBD and psychiatric conditions. 2. Significant and sustained modulation of Gut Microbiome composition. 3. The study will contribute to the knowledge base on the gut-brain-microbiome axis and the potential therapeutic use of FMT in patients with FBD and psychiatric comorbidity. |