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CTRI Number  CTRI/2025/05/087286 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 17/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A prospective, parallel group, interventional and open label study to evaluate the effect of probiotics on glycemic control in prediabetic patients  
Scientific Title of Study   A prospective, parallel group, interventional and open label study to evaluate the effect of probiotics on glycemic control in prediabetic 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  Anjalika Brar 
Designation  Junior Resident 
Affiliation  Government Medical College Amritsar 
Address  Department of Pharmacology Government Medical College Circular Road Amritsar

Amritsar
PUNJAB
143001
India 
Phone  7986363187  
Fax    
Email  anjalika382@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navuyug Raj Singh 
Designation  Professor 
Affiliation  Government Medical College Amritsar 
Address  Department of Pharmacology Government Medical College Circular Road Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9878634358  
Fax    
Email  navyug69@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjalika Brar 
Designation  Junior Resident 
Affiliation  Government Medical College Amritsar 
Address  Department of Pharmacology Government Medical College Circular Road Amritsar

Amritsar
PUNJAB
143001
India 
Phone  7986363187  
Fax    
Email  anjalika382@gmail.com  
 
Source of Monetary or Material Support  
Governemnt Medical College Amritsar, Punjab, India Pin Code - 143001 
 
Primary Sponsor  
Name  Governemnt Medical College Amritsar 
Address  Governemnt Medical College Amritsar, Punjab, India Pin Code - 143001 
Type of Sponsor  Government medical college 
 
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 
Anjalika Brar  Government Medical College & Hospital Amritsar  Department of Pharmacology and Department of Medicine, Government Medical College Circular Road Amritsar, Punjab, India Pin Code - 143001
Amritsar
PUNJAB 
7986363187

anjalika382@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Medical College Amritsar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R730||Abnormal glucose,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diet control  Diet control according to American Diabetes Association recommended Medical Nutrition Therapy for 90 days 
Intervention  Probiotic  One Probiotic capsule OD with 2.5 billion CFU containing four probiotics strains Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardi for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1. Prediabetic patients visiting the Medicine Out Patient Department.
2. Both male and female patients of age more than 18 years.
3. Patients willing to join the study after giving the informed consent.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Patient not willing to provide a written consent for the study.
2. Patients who are currently on any lipid lowering agents.
3. Pregnant and lactating females.
4. Seriously and chronically ill patients.
5. Conditions of Inflammatory Bowel Disease and malabsorption.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary objective is to compare the levels of Fasting Plasma Glucose (FPG), Post Prandial Plasma Glucose (2h PG) and HbA1c in prediabetic patients on probiotic along with dietary control versus those on dietary control only.  Day 0
Day 42
Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective is to assess the effect of probiotic on Body Weight, BMI, Total serum cholesterol, LDL cholesterol, HDL cholesterol, & Triglycerides of prediabetic patients with dyslipidemia recruited in the study.  Day 0
Day 42
Day 90 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/05/2025 
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  

Prediabetes is a state of hyperglycemia with blood sugar levels below the cut-off levels for diabetes. Genetic, environmental, and metabolic risk factors contribute to the development of type 2 diabetes mellitus and an important role of nutritional factors and gut microbiota has been shown in the development of diabetes. Some of the recent studies indicate that changes in gut microbiota can promote insulin resistance and lead to diabetes. Understanding the involvement of gut microbiome in Diabetes Mellitus is a relatively new field and requires further research. Also, probiotics have been shown to improve or alter the gut microbiome as a useful intervention in various pathological states. The present study aims to evaluate the effect of probiotics on glycemic control in prediabetic patients. It will be prospective, parallel group, interventional and open label study of 90 days. It will comprise 70 prediabetic patients of either sex above the age of 18 years from the OPD of Department of Medicine, Guru Nanak Dev Hospital attached to Government Medical College, Amritsar. Patients will be randomly divided into two groups – A and B of 35 patients each. Group A will be prescribed 1 capsule (2.5 billion CFU) of probiotic OD along with diet control. Group B will be put on diet control only. Follow up will be done at day 42 and day 90. Patients will undergo assessment of Fasting plasma glucose, Post prandial plasma glucose, HbA1c, Total lipid profile and any adverse effects during the course of the study. Data will be compiled, tabulated and analyzed statistically.

 
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