| CTRI Number |
CTRI/2024/08/072837 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of probiotics in prediabetic patients |
|
Scientific Title of Study
|
A randomized double blinded placebo controlled comparative clinical
study to evaluate the safety and efficacy of probiotics in the management
of pre-diabetic patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: PROBIOTICS/16/24 Version: 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant |
| Affiliation |
Ki3 Private Limited |
| Address |
Room 2, Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant |
| Affiliation |
Ki3 Private Limited |
| Address |
Room 2, Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 Private Limited |
| Address |
Room No 1, Ki3 Private Limited, Regus Centre Level 2 Altius Block, No 1, SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| SA Pharmachem Pvt. Ltd., India. |
|
|
Primary Sponsor
|
| Name |
SA Pharmachem Pvt. Ltd., India. |
| Address |
220, Udyog Bhavan, Sonawala Road, Goregaon East, Mumbai – 400063 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Sakthi Balan |
DK Elite Health Care Center |
Room no. 1,First Floor, No.370, Cuddalore main Road,Nainarmandapam, Puducherry
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
| Dr M Venkatram MBBS MD |
East Coast Hospitals |
Room 1, General Medicine, 1, Paris Nager, Moolakulam, Puducherry-605010
Pondicherry
PONDICHERRY |
9042846842
labservices@eastcoasthospitals.com |
| Dr Anandakumar |
Oxymed Hospital and Research Institute |
No 14/1 2nd street, 3rd main road, Nandhanam, Chennai 600035
Chennai
TAMIL NADU |
9840036723
Srmc91@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethique De La Nature Association |
Approved |
| Ethique De La Nature Association |
Approved |
| Oxymed Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R739||Hyperglycemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One capsule twice daily orally for 90 days. |
| Intervention |
Probiotics |
One capsule twice daily orally for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Prediabetic participants with HbA1c 5.7 – 6.4
2. Willing and able to provide written informed consent prior to
performing study procedures.
3. Patients between the age of 18-65 years.
4. Males or females; females must be non-pregnant / non-lactating and
practicing adequate birth control measures if not menopausal.
5. Patient should have not participated in any other clinical trial during the
past 3 months. |
|
| ExclusionCriteria |
| Details |
1. Type 1 and type 2 diabetes mellitus
2. Concomitant gastrointestinal disorders (i.e., irritable bowel syndrome,
inflammatory bowel disease and coeliac disease)
3. Recent use (within the previous 4 weeks) of antibiotics and dietary
supplements (fish oil, probiotics, prebiotics, multivitamins, minerals,
nutraceuticals and herbal preparations)
4. K/C/o cardiovascular or renal complications.
5. Patients who are on immunomodulatory or immunosuppressants for any
other illness.
6. History of allergy to probiotics.
7. History of drug or alcohol abuse. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fasting and post prandial blood sugar levels. (Time points: Day 0,
Day 30, Day 60 and Day 90)
2. HbA1c levels (Time points: Day 0 and Day 90)
3. Overall global status of improvement and quality of life (Time
points: Day 0 and Day 90)
4. Change in the anthropometrics and blood pressure measurements
from baseline to post study (Time points: Day 0 and Day 90)
5. Change in lipid profile from baseline to post study (Time points:
Day 0 and Day 90) |
Day 0, Day 30, Day 60 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
â— Each patient will undergo a complete physical examination, blood
sugar level assessment before enrolment in the study.
â— Other blood parameters like CBC, RFT, LFT and lipid profile will
be done on Day 0 and Day 90 for safety purpose.
â— ADR monitoring |
Day 0 and 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2024 |
| 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="6"
Days="0" |
|
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
|
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 70 participants will be randomized into two groups. Dosing will be done twice daily orally for 90 days. Subjects will be asked to visit facility for their follow up on day 30, day 60 and day 90 and any other additional visits if needed.
Primary Outcome 1. Fasting and post prandial blood sugar levels. (Time points: Day 0, Day 30, Day 60 and Day 90) 2. HbA1c levels (Time points: Day 0 and Day 90) 3. Overall global status of improvement and quality of life (Time points: Day 0 and Day 90) 4. Change in the anthropometrics and blood pressure measurements from baseline to post study (Time points: Day 0 and Day 90) 5. Change in lipid profile from baseline to post study (Time points: Day 0 and Day 90) |