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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  
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 
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  
Status 
Not Applicable 
 
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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