| CTRI Number |
CTRI/2025/10/096239 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
19/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
usefulnessof probiotic lactobacillus tablet in improvig insulin action among early diabetic obese individual |
|
Scientific Title of Study
|
Effectiveness of Probiotics on improving Insulin Sensitivity among Prediabetic Obese South Indian Adult Population in teritary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moulisbabu |
| Designation |
Post graduate student |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
Pondicherry Institute of Medical SCiences,ganapathichettikulam,kalapet,puducherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7094260902 |
| Fax |
|
| Email |
drmoulisbabu10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vasanthi |
| Designation |
Professor & consultant |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
Pondicherry Institute of Medical SCiences,ganapathichettikulam,kalapet,puducherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9677861288 |
| Fax |
|
| Email |
vasanthikavitha2004@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Moulisbabu |
| Designation |
Post graduate student |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
Pondicherry Institute of Medical SCiences,ganapathichettikulam,kalapet,puducherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7094260902 |
| Fax |
|
| Email |
drmoulisbabu10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences,ganapathichettikulam,kalapet,puducherry-605014 |
|
|
Primary Sponsor
|
| Name |
DrMoulisbabu |
| Address |
Pondicherry Institute of Medical SCiences ganapathichettikulam kalapet puducherry 605014 |
| Type of Sponsor |
Other [funded by myself] |
|
|
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 |
| Dr Moulisbabu |
Pondicherry Institute of Medical SCiences |
Ganapathichettikulam,Kalapet,Puducherry-605014
Pondicherry
PONDICHERRY |
7094260902
drmoulisbabu10@gmail.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
stable volunteers with
Prediabetes (defined as Fasting Blood Glucose 100–125 mg/Dl or Post prandial glucose 140-200mg/dl or HbA1c 5.7–6.4%). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo |
b complex capsules will be used as placebo, given per orally BD dose for 3 months |
| Intervention |
probitics capsules (brand name:prebo) |
each capsule contains probiotics bacteria of
1.bifidobacterium bifidum 150 million
2.bifidobacterium longum 150 million
3.streptococcus thermophilus 150 million
4.lactobacillus acidophilus 300 million
patient will receive one capsules per orally as BD dosage for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged more than or equal to 18 years.
BMI more than or equal 25 (obese as per Asian criteria) or waist circumference more than 102cm in male,more than 88cm in female.
Prediabetes (defined as Fasting Blood Glucose 100–125 milligram per decilitre or Post prandial glucose 140-200milligram per decilitre or HbA1c 5.7–6.4. |
|
| ExclusionCriteria |
| Details |
1.Patient on steroids, OCP, antibiotic intake (1 week).
2.Current or recent (past 3 months) probiotic/prebiotic supplementation.
3.Chronic diarhoea.
4.Pregnancy or lactation.
5.Severe hepatic, renal, or cardiac illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in insulin sensitivity as measured by HOMA-IR index. |
fasting insulin level checked at begining of the study ie sample collected at day 0 and at the end of the study ie once the patiet complete 90 days of probiotic course |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)fasting blood glucose
2)serum insulin level
3)lipid profile |
checked at begining of the study and at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="2"
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
|
Title Effectiveness of Probiotics on Improving Insulin Sensitivity Among Prediabetic Obese South Indian Adults in a Tertiary Care Hospital A Randomized Controlled Trial
Background
India has rising rates of obesity, prediabetes, and diabetes.
The gut microbiome plays an important role in metabolism.
Probiotics, especially Lactobacillus strains, may improve insulin sensitivity and prevent progression from prediabetes to diabetes.
Indian data, especially from South India, is limited.
Objectives
Primary: To evaluate the effect of probiotic supplementation on insulin sensitivity (measured by HOMA-IR).
Secondary: To assess changes in fasting glucose, serum insulin, HbA1c, lipid profile, and to check safety/tolerability of probiotics.
Methods:
Design: Randomized, open-label, placebo-controlled clinical trial.
Setting: Puducherry tertiary care hospital.
Duration: 2 years (June 2025 – June 2027).
Participants: 150 obese (BMI more than or equal to 25 kg/m²), prediabetic adults aged more than 18 years.
Intervention:
Group A: Probiotic capsules (containing Bacillus mesentricus, Lactobacillus acidophilus, Streptococcus thermophilus) twice daily for 12 weeks.
Group B: Placebo capsules for 12 weeks.
Assessments: Baseline, 6 weeks, and 12 weeks – anthropometry, fasting glucose, insulin, HbA1c, lipid profile.
Outcome: HOMA-IR calculation before and after intervention.
Sample Size: 150 (75 per group), based on previous trial data.
Ethics & Safety:
IEC approval and informed consent obtained.
Minimal risk, probiotics considered safe.
Monitoring for adverse events.
Expected Outcomes:
Improved insulin sensitivity (lower HOMA-IR).
Reduction in fasting glucose, insulin, HbA1c, and better lipid profile.
Data to support inclusion of probiotics in prediabetes management.
Budget: Rs.1.22 lakh (self-funded by investigator) |