| CTRI Number |
CTRI/2024/07/071576 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Probiotic Supplementation on Metabolic profile and Inflammatory parameters in Prediabetic Obese Patients in A Tertiary Care Hospital: A Double Blind, Randomized, Placebo Controlled Trial |
|
Scientific Title of Study
|
Effect of Probiotic Supplementation on Metabolic Inflammation in Prediabetic Obese Patients in A Tertiary Care Hospital: A Double Blind, Randomized, Placebo Controlled
Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunkumar R |
| Designation |
Postgraduate Resident Doctor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Pharmacology, SRM Medical College Hospital and Research Centre, Kattankulathur
SRM Medical College Hospital and Research Centre, Kattankulathur, 603211
Chennai
TAMIL NADU
603211
India |
| Phone |
8072097730 |
| Fax |
|
| Email |
drarun094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sathyanarayanan V |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Pharmacology, SRM Medical College Hospital and Research Centre, Kattankulathur
SRM Medical College Hospital and Research Centre, Kattankulathur, 603211
Chennai
TAMIL NADU
603211
India |
| Phone |
9384633405 |
| Fax |
|
| Email |
sathyanv@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sathyanarayanan V |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Pharmacology, SRM Medical College Hospital and Research Centre, Kattankulathur
SRM Medical College Hospital and Research Centre, Kattankulathur, 603211
Chennai
TAMIL NADU
603211
India |
| Phone |
9384633405 |
| Fax |
|
| Email |
sathyanv@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre,Potheri,SRM Nagar,Kattankulathur, Tamilnadu -603211 |
|
|
Primary Sponsor
|
| Name |
Arunkumar R |
| Address |
Department of Pharmacology, SRM Medical College Hospital and Research Centre, Kattankulathur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrArunkumar R |
SRM Medical College Hospital and Research Centre |
Department of Pharmacology, SRM Medical College Hospital and Research Centre, Kattankulathur
Chennai
TAMIL NADU |
8072097370
drarun094@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Students,SRM Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lactic acid bacillus capsule 120 million spores |
1 capsule, once daily in the morning, after food, for 12 weeks |
| Comparator Agent |
Placebo Capsule |
1 capsule, once daily in the morning, after food, for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Prediabetic patients
Obesity patients |
|
| ExclusionCriteria |
| Details |
Known history of gastrointestinal malabsorption, chronic diarrhoea.
Antibiotic consumption or intestinal infection in 3 months
Pregnancy, lactation, psychiatric patients |
|
|
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 |
| Improvement in prediabetic state by estimating FBS, PPBS and HbA1c |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in insulin resistance by estimating TyG index, TG/HDL C ratio
2.Improvement in inflammation – TNF alpha, Malondialdehyde (MDA)
3.Improvement in Quality of life assessed by questionnaire (Shortform Health Survey) SF-36 |
12 weeks |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="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
|
This MD thesis proposal aims to assess the impact of probiotic supplementation on metabolic inflammation in prediabetic obese patients. The study, with a sample size of 70, will evaluate glycemic control, insulin resistance, oxidative stress, and gut permeability. Participants will be randomized into probiotic and placebo groups, receiving treatment for 12 weeks, with regular follow-ups to monitor compliance and adverse effects. The study’s outcomes may contribute valuable insights to the limited body of randomized control trials on the gut microbiome’s role in prediabetes and obesity. |