| 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
|
|
|
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
|
|
|
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. |