| CTRI Number |
CTRI/2022/06/043239 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
12/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Bacillus coagulans MTCC 5856 in management of acute diarrhea in children |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of Bacillus coagulans MTCC 5856 in management of acute diarrhea in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CW/97/BCG_ADRH/II/MAR/21 Ver.No.1.0 date 24-03-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Thumjaa |
| Designation |
Professor, Dept of Paediatrics |
| Affiliation |
Aarupadai Veedu medical College & Hospital |
| Address |
Aarupadai Veedu medical College & Hospital
Cuddalore Main Road, Kirumampakkam,
Puducherry-607403
Cuddalore Main Road, Kirumampakkam,
Puducherry-607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9841573725 |
| Fax |
|
| Email |
thumjaa.annamalai@avmc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaji Paulose |
| Designation |
General Manager |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
Sami-Sabinsa Group Limited
19/1 & 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
19/1 & 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
shaji@clinworld.net |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alphons Philips |
| Designation |
Vice President |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
Sami-Sabinsa Group Limited
19/1 & 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
19/1 & 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
alphons@clinworld.net |
|
|
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, Peenya II Phase, Bengaluru, Karnataka
|
| 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Thumjaa |
Aarupadai Veedu medical College & Hospital |
Aarupadai Veedu medical College & Hospital
Cuddalore Main Road, Kirumampakkam,
Puducherry-607403
Pondicherry
PONDICHERRY |
9841573725
thumjaa.annamalai@avmc.edu.in |
| Dr Chadalavada Nagarjuna |
Aditya Multi Speciality Hospital |
13-3-52, 3rd Line, Gunturivari Thota, Kothapet Beside Peoples Trauma
Guntur
ANDHRA PRADESH |
8500454689
08632220395
naanichadalavada@gmail.com |
| Dr Jyotsna Seepana |
Government Medical college & Government General Hospital (Old RIMSGGH) |
Department of Paediatrics,
Government Medical college & Government General Hospital,
Srikakulam - 532001
Srikakulam
ANDHRA PRADESH |
9966612126
08942-279033
drjyotsnaggh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Aarupadai veedu Medical College & Hospital |
Approved |
| IEC Aditya Multispeciality Hospital |
Approved |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
acute diarrhea in children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactospore® (Bacillus coagulans MTCC 5856 Spores) |
4 Hundred Million Bacillus coagulans MTCC 5856 CFU + ORS + Zinc, twice daily for 5days |
| Comparator Agent |
Placebo (Maltodextrin) |
Placebo + ORS + Zinc, twice daily for 5days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 1 to 10 years diagnosed with acute diarrhea.
2.Children who experienced more than 3 watery stools within last 24 hours.
3.Signed informed consent from one of the parents/legal guardians.
4.Children aged above 7 years willing to provide verbal assent will be counter signed by Parents.
5.Parents’/legal guardians’ willing to comply with all its procedures.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who require antibiotics treatment.
2.Subject who require intravenous fluid therapy.
3.Severe diarrhea which requires treatment other than ORS.
4.Severe dehydration as per WHO dehydration scale.
5.Immunodeficiency.
6.Malnourished (weight for height < 3 SD of WHO charts).
7.Surgery within one month prior to inclusion.
8.Children suffering from severe chronic illness.
9.Chronic pathologies (e.g.: cardiopathies, nephropathies, chronic gastrointestinal pathologies, endocrinopathies).
10.No consumption of commercial products containing probiotics including Yakult, during the study period.
11.Participation in any other clinical trial within 4 weeks prior to entry into the study.
12.Children Hospitalized for Pneumonia and acute gastroenteritis.
13.Children having bilious vomiting, hematochezia, pancreatic dysfunction or insufficiency judged by medical history.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a)Mean duration of diarrhea (expressed in hours), as counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score a score 5 is described as normalization of stool)
b)Mean diarrhea frequency per day after initiation of treatment
|
1 Day 3 & Day 5
2 Day 3 & Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Perceived efficacy among caregivers per perceived efficacy scale.
b)Dehydration status evaluated as per WHO classification.
c)Occurrence of adverse events.
|
Day 3 & Day 5 |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
At screening visit, demographics, vital signs, physical examination, medical and medication history will be done to assess the eligibility criteria by the Pediatrician. The eligibility criteria will be verified. If the subject is found eligible, he/she will be randomized, and Investigational product will be dispensed to the parents or legal guardian to administer orally twice daily to the children. Stool sample will be collected for rotavirus and adenovirus screening. Children will be under observation of study team for six hours post 1st dose. Parents will be given subject diary and will be instructed to record diarrhea frequency and duration of diarrhea as well as investigational product compliance on daily basis. Information regarding the reporting of adverse events will be provided to the parents and will be instructed to visit site on day 3 and day 5. On day 3 and 5, vitals, physical examination, concomitant medication will be recorded. Duration and frequency of the diarrhea will be recorded in diary for all 5 days. Bristol stool chart will be assessed for all the episodes for all 5 days in a diary. Perceived efficacy scale of caregivers will be assessed on day 3 and day 5. Investigational product accountability will be done on day 5. The subject diary will be collected on day 5. |