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CTRI Number  CTRI/2018/02/012148 [Registered on: 26/02/2018] Trial Registered Retrospectively
Last Modified On: 28/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Fecal Microbiota Therapy]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Stool transplant as treatment in ulcerative colitis 
Scientific Title of Study   The Role of Fecal Microbiota Transplantation for maintenance of remission in patients with ulcerative colitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arshdeep Singh 
Designation  Senior Resident 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana
Tagore Nagar, Civil Lines
Ludhiana
PUNJAB
141001
India 
Phone    
Fax    
Email  drarshdeepsingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajit Sood 
Designation  Professor and Head 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana
Tagore Nagar, Civil Lines
Ludhiana
PUNJAB
141001
India 
Phone    
Fax    
Email  ajitsood10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arshdeep Singh 
Designation  Senior Resident 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana
Tagore Nagar, Civil Lines
Ludhiana
PUNJAB
141001
India 
Phone    
Fax    
Email  drarshdeepsingh@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Ludhiana 
 
Primary Sponsor
Modification(s)  
Name  Arshdeep Singh 
Address  Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana 
Type of Sponsor  Other [Self] 
 
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 
Arshdeep Singh  Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana   Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB 		 9815337764

drarshdeepsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dayanand Medical College and Hospital, Ludhiana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K51||Ulcerative colitis, Ulcerative Colitis in Remission,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fecal Microbiota Transplant  Patients suffering from Ulcerative Colitis who are in clinical remission will be enrolled after obtaining informed consent. Donor faeces (80 gm) will be diluted in 200-300 ml normal saline. After proper blending, the slurry will be filtered and particulate matter will be removed. The resultant solution will be administered to the patient through colonoscopy, within 6 hours of preparation. Patient will be encouraged to retain the solution for as long as possible. These FMTs will be done once every two months for a total duration of 6 months (i.e. three sessions of FMT). High fiber diet will be advised to stimulate proliferation of infused bacteria. The subjects will be continued on their standard of care pharmacological maintenance regimen with 5-ASA compounds/ immunomodulators. 
Comparator Agent  Placebo  Subjects in this group will receive placebo through colonoscopy. The standard of care pharmacological maintenance regimen with 5-ASA compounds/immunomodulators will be continued. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Confirmed Ulcerative Colitis patients who are in clinical remission (defined as complete resolution of symptoms) for a minimum duration of 6 months.
2. Patients must be on stable medication regimen for at least 6 months prior to enrollment.
3. Able to give informed consent and/or assent as appropriate 
 
ExclusionCriteria 
Details  1. Patients with active disease
2. Patients having toxic megacolon
3. Treatment naïve patients
4. Pregnant and lactating ladies
5. Prior colectomy
6. Positive stool test for any of the following: Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, E. coli by standard stool culture.
7. Regular probiotic supplement use within prior 4 weeks to enrollment
8. Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
9. Patients unwilling or unable to give consent or participate in all study requirements
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of clinical response in two groups  One Year 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of Endoscopic activity of Ulcerative Colitis  1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/04/2016 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 Pilot Study Published Sood A, Mahajan R, Singh A, et al. Role of Faecal Microbiota Transplantation for Maintenance of Remission in Patients With Ulcerative Colitis: A Pilot Study. J Crohns Colitis. 2019;13(10):1311–1317. doi:10.1093/ecco-jcc/jjz060 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The role of gut microbiome in health and inflammation has gained international attention in recent times. The success of fecal microbiota transplantation (FMT) (a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with the goal being to introduce or restore a stable microbial community in the gut) in treatment of Clostridium difficile infection led to the hypothesis that it may play an important role in Inflammatory Bowel Disease (IBD) as well. Randomized controlled trials have demonstrated efficacy of FMT in induction of remission in mild-moderate Ulcerative Colitis (UC). However there is paucity of data which looks into the role of FMT in maintenance of remission in Ulcerative Colitis. This study aims to study the role of fecal microbiota transplantation in maintenance of remission in UC. Patients will receive retention enemas or through colonoscopy and will be looked for remission/response at 6 months and 1 year.

 
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