| CTRI Number |
CTRI/2024/02/062721 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Probiotics safety study on healthy human volunteers |
|
Scientific Title of Study
|
A randomized doubleblind placebocontrolled three arm parallel study to evaluate the safety of FructoSpore in healthy human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CW/123/FTS_SFTY/I/JAN/24Ver1.0 22Jan2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMeghana Murthy |
| Designation |
Consultant General Medicine |
| Affiliation |
VegusSuper Speciality Hospital |
| Address |
No6 7 8 18th Cross4th Main Malleshwaram Bangalore
India
No 6 7 8 18th Cross4th Main Malleshwaram Bangalore
India
Bangalore
KARNATAKA
560055
India |
| Phone |
7259214727 |
| Fax |
|
| Email |
meggydoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami-Sabinsa Group limited |
| Address |
19 1 & 19 2 I Main II Phase Peenya Industrial AreaBangalore.
Bangalore
KARNATAKA
560058
India
Bangalore
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami-Sabinsa Group limited |
| Address |
19 1 19 2 I Main II Phase Peenya Industrial Area Bangalore
KARNATAKA
560058
India
19 1 19 2 I Main II Phase Peenya Industrial Area Bangalore
KARNATAKA
560058
India
Bangalore
KARNATAKA
560058
India |
| Phone |
08068527777 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami Sabinsa Group Limited 19 1 & 19 2 I Main II Phase Peenya Industrial Area, Bangalore
Karnataka 560058 |
|
|
Primary Sponsor
|
| Name |
Sami Sabinsa Group Limited |
| Address |
19 1 & 19 2 I Main II Phase Peenya Industrial Area Bangalore
Karnataka 560058 |
| Type of Sponsor |
Other [[Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parashuram |
Dr. BR AmbedkarMedical Collegeand Hospital |
48Indrajit Swamy Layout Shampur Main Road KG Halli Ambedkar Medical College Bengaluru Karnataka
Bangalore
KARNATAKA |
9986311450
drbhavimani@gmail.com |
| Dr Meghana Murthy |
Vegus Super Speciality Hospital |
No 6 7 8 18th ross4th Main MalleshwaramBangalore 560055
Bangalore
KARNATAKA |
7259214727
meggydoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committeeDr. BR Ambedkar Medical collegeInstitutional Ethics Committee |
Approved |
| VagusInstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Safety study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FructoSpore
1. Arm 1 10 Billion spores
2. Arm 2 20 Billion spores |
1. One capsule Once a day after dinner
2. One capsule Once a day after dinner for 30 days |
| Comparator Agent |
Placebo
Maltodextrin Capsule 200mg |
One capsule Once a day after dinner for 30 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1.1. Healthy male and female participants whose age 18 and 49 years and having Body Mass Index BMI 29.9
2.2. Participants must provide a written and signed informed consent and comply with requirements of the study.
3.
3.3. Must be able to swallow oral medications for 30 days on a daily basis and comply with
4.4. Absence of any clinically significant disease or abnormal laboratory values as decided by the PI
5. 5. Participant must consume Investigational Products only during the study. He or She must refrain from consuming any prebiotic, postbiotic, vitamins, minerals & any other supplements during the study
6. 6. Female participant of childbearing potential must use an approved method of contraception and must be willing to continue its use throughout the study duration or female participant of non-childbearing potential |
|
| ExclusionCriteria |
| Details |
1. Females who are planning to become pregnant in the next three months or had a positive pregnancy test at the time of screening and study period.
2. Participants with a prior history of clinically significant diseases disorders allergy.
3. Participant with any of the following shall be excluded from the study- inflammatory, autoimmune diseases, diabetes, lactose intolerance, immune deficiency, hyperthyroidism or hypothyroidism, history of GERD, gastric ulcer, and irritable bowel disease.
4. Participant with a prior history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease.
5. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any food items, medicines, investigational product or its excipients.
6. History of organ transplantation.
7. Participants had undergone any surgery during the last six months.
8. Use of any medications within 1 month before the start of the study.
9. Use of systemic corticosteroids within 1 month before the start of the study.
10. Use of prebiotics postbiotics vitamins minerals dietary or herbal supplements within 15 days before the start of the study and not willing to refrain from the use of any new vitamins and or minerals and or dietary and or herbal supplements during the study.
11. History of difficulty in swallowing food and medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the safety of FructoSpore in Healthy Human Volunteers
2. Safety is determined through changes in lab test results and incidence of adverse events |
1. Randomization day to Day to 31
Safety Follow-up at the end of the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the changes in Gastrointestinal Symptom Rating Scale and Bristol Stool Score compared to placebo.
2.o Mean change in the Bristol Stool Score |
1.Randomization Day to Day 31
2.Randomization Day to Day 31 |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
02/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is A randomized, double-blind, placebo-controlled, three-arm, parallel study to evaluate the safety of 10 Billion , 20 Billion Spores of FructoSpore in comparison with placebo in healthy human volunteers. The study involves 31 days, i.e., from the beginning till the end of the treatment. A screening test will be conducted 5 days prior to the enrollment into the study. During the study period, the study participants must visit the study site 3 times in-person and connect with the study investigator once remotely over the phone for a telephonic discussion which will be conducted after 7 days from the date of last visit |