| CTRI Number |
CTRI/2026/02/102862 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Probiotics and Exercise for Sleep Improvement in Undergraduates |
|
Scientific Title of Study
|
Investigation of the effects of Probiotics along with Exercise on the sleep quality among Indian Medical undergraduates. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirmiti Bhaven Mahadevia |
| Designation |
MBBS-UG Final Year Student |
| Affiliation |
MBBS Student, Jawaharlal Nehru Medical College, KAHER, Belagavi |
| Address |
Room no. A7, RC Ladies Hostel, Jawaharlal Nehru Medical College Nehru Nagar, Belagavi JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum KARNATAKA 590010 India |
| Phone |
9699633753 |
| Fax |
|
| Email |
nirmiti124@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Aarti Bhosale |
| Designation |
Assistant Professor, Department of Pharmacology |
| Affiliation |
Department of Pharmacology, Jawaharlal Nehru Medical College, KAHER, Belagavi |
| Address |
Department of Pharmacology Jawaharlal Nehru Medical College Campus, Nehru Nagar, Belagavi Jawaharlal Nehru Medical College, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum KARNATAKA 590010 India |
| Phone |
9632707766 |
| Fax |
|
| Email |
draartibhosale.mbbs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nirmiti Bhaven Mahadevia |
| Designation |
MBBS-UG Final Year |
| Affiliation |
MBBS Student, Jawaharlal Nehru Medical College, Belagavi |
| Address |
Room no. A7, RC Ladies Hostel, Jawaharlal Nehru Medical College Nehru Nagar, Belagavi JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum KARNATAKA 590010 India |
| Phone |
9699633753 |
| Fax |
|
| Email |
nirmiti124@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR Short Term Studentship 2024 grant |
|
|
Primary Sponsor
|
| Name |
ICMR Short Term Studentship Grant 2024 |
| Address |
Indian Council of Medical Research Headquarters, Ansari Nagar East, New Delhi - 110029 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Nirmiti Bhaven Mahadevia |
Jawaharlal Nehru Medical College, KAHER, Belagavi |
1st Floor, Department of Pharmacology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi Belgaum KARNATAKA |
9699633753
nirmiti124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE, JAWAHARLAL NEHRU MEDICAL COLLEGE, NEHRU NAGAR, BELAGAVI-590010 (KARNATAKA-INDIA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo control group |
Participants in the comparator group will receive the placebo along with daily exercise. |
| Intervention |
probiotic supplementation along with structured physical exercise |
Intervention group: Participants will receive oral probiotic supplementation along with a structured strength training program.
Comparator: Control group receiving no probiotic supplementation, only exercise.
Probiotic: Oral probiotic capsule containing Lactobacillus and Bifidobacterium species, administered once daily after meals.
Strength training component: Supervised or self-performed resistance/strength training exercises commonly used in gym-based workouts, targeting major muscle groups. Training sessions will include body-weight and/or resistance exercises performed at moderate intensity.
Frequency and duration: Approximately 30–45 minutes per session, 3–5 sessions per week.
Total intervention duration: 8 weeks.
Compliance monitoring: Self-reported workout log and periodic follow-up of blister packs
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
-Healthy medical undergraduate students who are willing to comply with study protocols
-Physically able to perform moderate exercise
-Baseline poor or suboptimal sleep quality (PSQI more than 5)
|
|
| ExclusionCriteria |
| Details |
-Diagnosed sleep disorders
-Current psychiatric illness or use of psychotropic medications
-GI impaired students already consuming probiotics
-Regular use of sleep altering substances and devices
-Chronic medical illnesses affecting sleep
-Autoimmune disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in sleep quality, assessed pre- and post- intervention using Pittsburg Sleep Quality Index (PSQI)
Secondary Outcome - Change in inflammatory markers (IL-10 and IL-6) measured using pre and post intervention blood samples
|
Pittsburg Sleep Quality Index (PSQI) Score- assessed at baseline, 4 weeks and 8 weeks
Inflammatory markers (IL-10 and IL-6) will be assessed at Baseline and at the end of 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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="0" Months="3" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Poor sleep quality is common among medical undergraduate students and is associated with stress, lifestyle factors, and impaired health. Regular physical exercise is known to improve sleep quality, while probiotics have been suggested to influence sleep and mental well-being through modulation of inflammatory and physiological processes. This interventional study aims to assess the effect of probiotic supplementation along with regular exercise on sleep quality among medical undergraduate students and to compare the outcomes with exercise alone. The study will be conducted among 60 undergraduate medical students aged 18–21 years at Jawaharlal Nehru Medical College, Belagavi, with impaired sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI). Participants will be randomly allocated into two groups: Control group will receive a standardized exercise regimen with placebo, and Experimental group will receive the same exercise regimen along with daily multi-strain probiotic supplementation for a period of eight weeks. Students with chronic medical illnesses, psychiatric conditions, or medication use affecting study outcomes will be excluded. Sleep quality will be assessed using PSQI at baseline and at the end of the intervention. Blood samples will be collected at baseline and after eight weeks to assess inflammatory markers including TNF-alpha, IL-6, and IL-10. Pre- and post-intervention outcomes will be compared within and between the two groups to evaluate the effect of probiotics combined with exercise on sleep quality. This study aims to expand the existing knowledge about probiotics and their effects on psychological well-being (psychobiotics). This can provide insights into the potential of probiotics and exercise as non-pharmacological interventions for sleep disorders, contributing to a better understanding of the gut-brain axis and its role in sleep regulation.
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