| CTRI Number |
CTRI/2026/02/102849 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The role of selenium in gut inflammation and Dysbiosis |
|
Scientific Title of Study
|
Effect of Selenium supplementation in modulating Sarcopenia outcomes
through Gut dysbiosis in Ulcerative Colitis patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gurseen Rakhra |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA
121004
India |
| Phone |
08368047368 |
| Fax |
|
| Email |
gurseen.fas@mriu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Gurseen Rakhra |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
HARYANA
121004
India |
| Phone |
08368047368 |
| Fax |
|
| Email |
gurseen.fas@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Gurseen Rakhra |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
HARYANA
121004
India |
| Phone |
08368047368 |
| Fax |
|
| Email |
gurseen.fas@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies. Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004. India |
|
|
Primary Sponsor
|
| Name |
Manav Rachna International Institute of Research and Studies |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gurseen Rakhra |
Dr. Ram Manohar Lohia Hospital |
IBD Clinic, Nursing Home Block, Dr. Ram Manohar Lohia Hospital Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi 110001
Central
DELHI |
08368047368
gurseen.fas@mriu.edu.in |
| Gurseen Rakhra |
Manav Rachna International Institute of Research and Studies |
Block Q, Department of Nutrition and Dietetics, Faculty of Allied Health Sciences. Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA |
08368047368
gurseen.fas@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Research Ethics Committee, MRIIRS, FARIDABAD |
Approved |
| RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo comprising of 200 microgram maltodextrin will be given per day for 3 months |
| Intervention |
Selenium supplementation |
selenium supplementation in the form of Selenomethionine will be given in the form of capsules
dosage- 200 microgram per day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with confirmed gut dysbiosis,
sarcopenia and selenium deficiency in Ulcerative colitis patients |
|
| ExclusionCriteria |
| Details |
Females, co-morbidities (heart failure, diabetes mellitus, kidney disease and
COPD) and patients on other diseases medications |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study aims to establish the role of Selenium supplementation in improving sarcopenia outcomes
by modulating the gut dysbiosis in UC patients |
baseline
endpoint after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved quality of Life |
baseline
endpoint after 3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/03/2026 |
| 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="1"
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
|
Inflammatory Bowel disease (IBD) has become a global health issue on national and international platforms. IBD shows two main types as per its location; one is Ulcerative Colitis (UC) and the second is Crohn’s disease (CD). UC has three stages mild, moderate, and severe. Patients suffering from UC have a great risk of malnutrition and micronutrient deficiency such as iron, zinc, copper, Manganese, and selenium. Selenium (Se) deficiency is a common micronutrient deficiency in UC patients. The deficiency arises due to the competitive demand of the human body and microbiota in UC patients for Se. Se has antioxidant properties that help reduce the severity in UC patients. Gut dysbiosis is one of the factors of UC that appears due to a disbalance in beneficial and harmful bacteria produced in the gut. Another hallmark of UC is sarcopenia which develops due to chronic inflammation. In addition, sarcopenia is caused due to gut dysbiosis and micronutrient deficiency. Se as an oral supplement can target gut dysbiosis, sarcopenia, and UC symptoms. In this study, Se as an oral supplement will be given to patients in the form of Selenomethionine to improve the symptoms and severity of sarcopenia by targeting gut dysbiosis in UC patients. |