| CTRI Number |
CTRI/2025/07/091085 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on a Healthy Food Supplement Containing Good Bacteria to Improve Gut Health and Control Blood Sugar in People with Type 2 Diabetes |
|
Scientific Title of Study
|
Development and Evaluation of a Probiotic-Enriched Prebiotic Supplement on Gut Microbiota in Individuals with Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithiya SL |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Vidya Sudha Block (3rd floor), Department of Clinical Nutrition, Room No. 03, Sri Ramachandra Institute of Higher Education and Research,
No.1, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
6383226862 |
| Fax |
|
| Email |
u022401113@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Preetha |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Vidya Sudha block (3rd floor), Department of Clinical Nutrition, Room No. 03, Sri Ramachandra Institute of Higher Education and Research
No.1, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840980947 |
| Fax |
|
| Email |
preetha.n@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Preetha |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Vidya Sudha block (3rd floor), Department of Clinical Nutrition, Room No. 03, Sri Ramachandra Institute of Higher Education and Research
No.1, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840980947 |
| Fax |
|
| Email |
preetha.n@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research NPV Ramaswamy Udayar Fellowship |
| Address |
Sri Ramachandra Institute of Higher Education and Research
(Deemed to be University)
No.1 Ramachandra Nagar
Porur Chennai 600 116
Tamil Nadu India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 N Preetha |
Sri Ramachandra Medical Centre |
Sri Ramachandra Institute of Higher Education and Research,
No.1, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9840980947
preetha.n@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra University, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Diet counselling and diet chart will be provided |
| Intervention |
Probiotic enriched Prebiotic supplement |
Duration of the supplement: 15 weeks. Developed product needed to be consumed by study participants for the entire study duration of 15 weeks will be delivered once in a week by carefully labelling with instructions. The adherence to the supplement will be monitored through phone calls and during their visit to the diabetic OPD.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects will be included based on the following criteria: The study participants include people above 18 years with uncontrolled Type 2 diabetes has HbA1c (10-14%), and CBG (250-400mg/dl). Willing to participate in the study, who are getting treatment at Sri Ramachandra Medical Centre and SRH.
|
|
| ExclusionCriteria |
| Details |
To exclude gestational and other diabetes types (maturity-onset diabetes of the young (MODY), type 1 diabetes, and Latent Autoimmune Diabetes in Adults (LADA). To exclude subjects with any chronic illness and immunocompromised state (Chronic Kidney Disease, Chronic Liver Disease, oncological condition, and AIDS). People who are allergic to the prescribed product. On antibiotic supplements and steroid treatment. |
|
|
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 |
OUTCOME PARAMETERS:
HbA1c, CBG, FBS, PPBS- Baseline, midline, and endline supplementation.
HOMA IR- Baseline, midline, and endline supplementation.
C-REACTIVE PROTEIN- Baseline, midline, and endline supplementation. |
Baseline (0 week): HbA1c, CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN
Midline (8th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN
Endline (15th week): CBG, FBS, PPBS, HOMA IR, C-REACTIVE PROTEIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fecal DNA extraction:
The gut microbiota is commonly measured through the fecal DNA extraction method. The fecal DNA extraction method will be measured to the randomly selected group after supplementation.
Fecal sample collection
After 15 weeks of supplementation, the fecal samples of randomly selected 5 individuals from each experimental & control group will be collected for DNA extraction experiments.
The fecal samples will be collected within 3-4 hours in sterile containers, will be promptly transported to the laboratory, & stored at a suitable temperature until DNA extraction for further analysis.
|
Endline 15th week |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2 |
|
Date of First Enrollment (India)
|
08/10/2025 |
| 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="0"
Months="3"
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
|
This randomized controlled clinical trial aims to assess the influence of a probiotic-enriched prebiotic supplement on gut microbiota and glycemic parameters in individuals with uncontrolled Type 2 Diabetes Mellitus. The supplement will be developed using millet and pulses as prebiotic sources, and Lactobacillus acidophilus and Bacillus coagulans as probiotic strains. A total of 52 participants aged above 18 years with HbA1c levels between 10–14% and capillary blood glucose (CBG) levels of 250–400 mg/dl will be randomly assigned to an experimental or control group. The experimental group will receive the developed supplement along with standard dietary management for 15 weeks, while the control group will receive only dietary management. Outcomes will include changes in gut microbiota (via fecal DNA extraction and 16S rRNA sequencing) and glycemic indicators such as HbA1c, CBG, FBS, PPBS, HOMA-IR, and CRP at baseline, midline, and endline. The study also includes product formulation, sensory evaluation, nutrient, microbial, and shelf-life analysis. Ethical clearance has been obtained, and informed consent will be taken from all participants. Study duration: 3 years Funding: Shri. N.P.V Udayar Research Fellowship Location: Sri Ramachandra Medical Centre and SRH, SRIHER (DU), Chennai
|