| CTRI Number |
CTRI/2022/09/045812 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Trial on pro-biotic health supplement for high altitude areas |
|
Scientific Title of Study
|
Study of human microbiome and probiotic supplementation under extreme environmental conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lilly Ganju |
| Designation |
Scientist G and Associate Director |
| Affiliation |
Defence Institute of Physiology and Allied Sciences |
| Address |
Room No 108, Division of Immunomodulation, Simulation Chamber Block, DIPAS, Lucknow Road, Timarpur, Delhi
HOD, Division of Immunomodulation, DIPAS, Lucknow Road, Timarpur, Delhi, 54
North
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
lganju@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chand Meena |
| Designation |
Scientist E and Co-PI |
| Affiliation |
Defence Institute of Physiology and Allied Sciences |
| Address |
Room No 112, Department of Molecular Biology, Simulation Chamber Block, DIPAS, Lucknow Road, Timarpur, Delhi
Department of Molecular Biology, DIPAS, Lucknow Road, Timarpur, Delhi, 54
North
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
rcmeena.dipas@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipti Prasad |
| Designation |
Scientist F and Head Tech Coord |
| Affiliation |
Defence Institute of Physiology and Allied Sciences |
| Address |
Room No 110, Main Building, DIPAS, Lucknow Road, Timarpur, Delhi
Room No 110, Main Building, DIPAS, Lucknow Road, Timarpur, Delhi
North
DELHI
110054
India |
| Phone |
|
| Fax |
01123932896 |
| Email |
dnprasad.dipas@gov.in |
|
|
Source of Monetary or Material Support
|
| Defence Research and Development Organization, Rajaji Marg, New Delhi 110011 |
|
|
Primary Sponsor
|
| Name |
Defence Institute of Physiology and Allied Sciences |
| Address |
Lucknow Road, Timarpur, Delhi, 54 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Defence Institute of High Altitude Research |
Leh, Ladakh, 901205 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Som Nath Singh |
Defence Institute of Physiology and Allied Sciences |
Lucknow Road, Timarpur, Delhi-110054
North West
DELHI |
011-23883112
9811664006
techcoord.dipas@gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (IHEC), DIPAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Digestion and Homeostasis of gut and oral microbiota at high altitude |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo formulation |
Sorbitol, Xylitol, Maltodextrine powder without microbial consortium and with similar visual and dissolving properties in water. 1 gm daily p.o. for 60 days. |
| Intervention |
Probiotic composition |
Sorbitol, Xylitol, Maltodextrine, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii, Bacillus coagulans at a dose of 1gm daily p.o. as health supplement for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
BMI: 18-27
No antibiotic treatment in last 3 months
No history of gastro-intestinal disease
Maintenance of oral hygiene |
|
| ExclusionCriteria |
| Details |
Subjects with pre-existing clinically identified digestive and GI tract disease including Chrones.
History of Bariatric surgery or intestinal injury |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Homeostasis of gut and oral microbiota ascertained through sequencing analysis |
Baseline at o months and monthly follow up for 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on physiological and biochemical parameters that are reported previously to be influenced by gut microbiota in scientific literature. Viz., Immunological: Cytokine, Chemokine, Immunoglobulin and complement factor profiling, Metabolic: Glucose, Hb1 Ac, Cortisol, Lipid Profile, Vitamin Profile. |
Same as primary outcome |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
15/02/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - either through email to director.dipas@gov.in or through published findings
- For how long will this data be available start date provided 31-07-2023 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The trial on probiotic health supplement is to evaluate its efficacy in maintaining homeostasis of gut and oral microbiota in hypobaric hypoxia and cold conditions prevalent in high altitude areas. Considering the burgeoning literature on effect of gut and oral microbiota on immunity and metabolism in human body, the study will also evaluate the effect of the supplementation of the probiotic on these related parameters. Study Design: Randomized double blind longitudinal interventional study will be conducted. The study will comprise of Placebo and Probiotic intervention group and will be conducted in the high altitude conditions of Ladakh. Baseline data will be acquired prior to administration of FSSAI approved probiotic supplement and follow up data will be acquired at intervals of 01 month for a total duration of 06 months. Study parameters: Microbial Profiling: DNA sequencing for microbial composition from stool and saliva samples General Physiology viz., Blood Pressure, BMI, HRV Biochemical Parameters: Lipid, Glucose, Vitamin, Stress Hormone profile from blood samples. Immunological Parameters: Cytokine, Chemokine, Immunoglobulin and complement factor profiling |