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CTRI Number  CTRI/2022/07/043847 [Registered on: 08/07/2022] Trial Registered Prospectively
Last Modified On: 07/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Fecal microbiota transplantation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Decreasing the multidrug resistant organisms in feces by fecal microbial transplantation 
Scientific Title of Study   To evaluate the role of phage transfer through fecal microbiota transplantation in causing anti-microbial gene depletion and intestinal decolonization from multidrug resistant organisms 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 3111, Office of Department of Gastroenterology and HNU, 3rd floor, Teaching block, AIIMS, New Delhi
All India Institute of Medical Sciences, Ansari Nagar (East), New Delhi
New Delhi
DELHI
110029
India 
Phone  9810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 3111, Office of Department of Gastroenterology and HNU, 3rd floor, Teaching block, AIIMS, New Delhi
All India Institute of Medical Sciences, Ansari Nagar (East), New Delhi
New Delhi
DELHI
110029
India 
Phone  9810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vineet Ahuja 
Designation  Professor 
Affiliation  Department of Gastroenterology and HNU, All India Institute of Medical Sciences 
Address  Room 3111, Office of Department of Gastroenterology and HNU, 3rd floor, Teaching block, AIIMS, New Delhi
All India Institute of Medical Sciences, Ansari Nagar (East), New Delhi
New Delhi
DELHI
110029
India 
Phone  9810707170  
Fax    
Email  vineet.aiims@gmail.com  
 
Source of Monetary or Material Support  
Department of Health Research, Government of India 
 
Primary Sponsor  
Name  Department of Health Research 
Address  2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Ahuja  AB2 ward, Department of Gastroenterology, 2nd floor, ward block, AIIMS  All India Institute of Medical Sciences, Ansari Nagar (East), AIIMS Campus, New Delhi-110029
New Delhi
DELHI 		 9810707170

vineet.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, (2) ICD-10 Condition: K509||Crohns disease, unspecified, (3) ICD-10 Condition: K839||Disease of biliary tract, unspecified, (4) ICD-10 Condition: K869||Disease of pancreas, unspecified, (5) ICD-10 Condition: K740||Hepatic fibrosis, (6) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fecal microbiota transplantation  Involves colonoscopic insertion of feces from donors into patients  
Comparator Agent  Sigmoidoscopy   After Peglec preparation as in colonoscopy, sigmoidoscopy (endoscopic visualisation of distal colon and rectum) and normal saline injection will be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients aged 18-75 years
Patients positive for target MDR organisms by culture-based tests, at the time of discharge.
No clinical evidence of active infection,
Patients who agree for FMT and subsequent follow-up.
Able to provide informed consent
 
 
ExclusionCriteria 
Details  Patients on concomitant antibiotics or likely to receive at the time of FMT
Patients who are immunocompromised (post bone marrow transplant, solid organ transplant recipients, HIV positive patients with CD4 count < 200 cells/cumm)
Patients unable to undergo colonoscopy due to comorbidity
Cirrhosis with CTP score more than or equal to 9
Pregnancy
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Detection of MDR organism in stool at 4 weeks after FMT or standard medical treatment  4 weeks or prior, as indicated 
 
Secondary Outcome  
Outcome  TimePoints 
Detection of change in stool microbiota after FMT
 		 4 weeks or prior, as indicated 
Detection of change in stool virome after FMT
 		 4 weeks or prior, as indicated 
Occurrence of any adverse event  4 weeks or prior, as indicated 
Infection with MDR organism
 		 4 weeks or prior, as indicated 
Need for antibiotics
 		 4 weeks or prior, as indicated 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/07/2022 
Date of Study Completion (India) 31/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/07/2024 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In this study, we wish to conduct a randomized controlled trial to study the impact of fecal microbiota transplant in reducing the load of antimicrobial resistant genes in the gut microbiome of patients who were previously hospitalized and admitted in our gastroenterology intensive care unit (ICU) and ward. Admitted patients will be tested for MDR organism colonisation in stool via culture and PCR methods. Those who are positive for MDR colonisation in gut, will be offered recruitement in our RCT. Recruited patients, after hospital discharge, will be randomised into FMT arm (fecal microbiota transplant) or sham intervention arm (sigmoidoscopy with normal saline injection). After 4 weeks, stool will again be tested for MDR organism colonisation. Also, stool metagenomics analysis will also be done to look for association with clearance of MDR organism post FMT. 

 
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