| CTRI Number |
CTRI/2024/01/062063 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Fecal Microbiota Transplant] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Fecal microbiota transplant capsules as a treatment in patients with ulcerative colitis |
|
Scientific Title of Study
|
Efficacy and Safety Of Oral Lyophilized Fecal Microbiome Capsules For Induction And Maintenance Of Remission In Moderately Severe Ulcerative Colitis |
| Trial Acronym |
FLORAL-UC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajit Sood |
| Designation |
Professor and Head |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Gastroenterology
Third floor
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajit Sood |
| Designation |
Professor and Head |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Gastroenterology
Third floor
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajit Sood |
| Designation |
Professor and Head |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Gastroenterology
Third floor
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana |
| Digestive Diseases Care Foundation, Ludhiana |
| Vardhman Textiles Limited, Ludhiana |
|
|
Primary Sponsor
|
| Name |
Vardhman Textiles Limited |
| Address |
Vardhman Premises, Chandigarh Road, Ludhiana, Punjab 141010 |
| Type of Sponsor |
Other [Corporate House] |
|
|
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 Ajit Sood |
Dayanand Medical College and Hospital |
Department of Gastroenterology, Third Floor, Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana 141001
Ludhiana
PUNJAB |
9815400718
ajitsood10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee (DTEC) Dayanand Medical College and Hospital, Civil Lines, Ludhiana-141001 (Pb.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K51||Ulcerative colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FMT capsule |
Patients with moderately active ulcerative colitis will receive FMT capsules in addition to the standard of care for induction and maintenance of remission.
The duration of induction therapy will be for 8 weeks. From week 8 till week 48, the patients who achieve clinical remission will continue to receive the FMT capsules for maintenance of remission. Participants will be contacted weekly to check compliance and for further reminders. |
| Comparator Agent |
Placebo Capsule |
Patients with moderately active ulcerative colitis will receive placebo capsules in addition to the standard of care for induction and maintenance of remission. The duration of induction therapy will be for 8 weeks. From week 8 till week 48, the patients who achieve clinical remission will continue to receive the placebo capsules for maintenance of remission. Participants will be contacted weekly to check compliance and for further reminders. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of UC with active disease, defined as a total Mayo score of 6–9, and a Mayo endoscopic subscore of 1 or more.
2. Any disease extent : E1, E2 or E3
3. Diagnosis (endoscopic or radiographic and histological) of UC at least 6 months prior to
enrolment into the study
4. Subjects who are willing and able to comply with treatment plan, laboratory
tests.
5. Subjects who are willing to provide a written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Subjects without previous treatment for IBD (i.e. treatment-naïve).
2. Active or latent or inadequately treated
infections(includingClostridiodes difficile, Cytomegalovirus, Mycobacterium tuberculosis, etc.)
3. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
4. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
5. Subjects with current malignancies or a past history of malignancies.
6. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease.
7. Pregnant females. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical remission (defined as total Mayo score ≤2, with no individual sub-score exceeding 1 point) |
Week 8, Week 48 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical response (defined as decrease in total Mayo score by at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub-score of at least 1 point or absolute rectal bleeding sub-score of 0 or 1) |
Week 8, Week 48 |
| Endoscopic remission (defined as endoscopic Mayo sub-score of 0) |
Week 8, Week 48 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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 - NO
|
|
Brief Summary
|
Ulcerative colitis (UC) is a chronic, disabling immune mediated inflammatory condition affecting the large bowel, which is thought to be caused by an aberrant interaction between the immune system and a dysbiotic intestinal microbiome. There is emerging evidence that faecal microbiota transplantation (FMT) is effective in treating UC. This is a double blind, randomised, placebo-controlled trial of orally administered lyophilized FMT capsules in patients with chronic active UC. |