| CTRI Number |
CTRI/2017/08/009543 [Registered on: 29/08/2017] Trial Registered Prospectively |
| Last Modified On: |
28/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of probiotic Bacillus clausii UBBC07 in children with Acute Diarrhoea |
|
Scientific Title of Study
|
A Multi-Center, Double Blind, Randomized, Parallel-Group, Two-Arm Study to Evaluate the Safety and Efficacy of Bacillus Clausii UBBC07 Suspension (BACIPRO) for the Treatment of Acute Diarrhoea in Children of Age 6 Months to 5 Years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: BC-UBBC07/PMS/2017/07 Version 1.0, 18 Jul 2017 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D C Pandey |
| Designation |
Pediatrician |
| Affiliation |
M V Hospital and Research Centre |
| Address |
M V Hospital and Research Centre
Department of Pediatrics
First Floor, Room No 01
314/30 Mirza Mandi Chowk
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415156419 |
| Fax |
|
| Email |
mvhrclko@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pawan Bhusari |
| Designation |
CEO |
| Affiliation |
Abiogensis Clinpharm Pvt Ltd |
| Address |
Abiogensis Clinpharm Pvt Ltd
8-2-596A and B/1 Road No 10
Banjara Hills
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
04038117077 |
| Fax |
04038117078 |
| Email |
pawanbhusari@abiogenesisclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Jayanthi |
| Designation |
Manager Business Development |
| Affiliation |
Unique Biotech Ltd |
| Address |
Unique Biotech Limited
Plot No 2 Phase-II
Alexandria Knowledge Park
Kolthur Village Shameerpet Mandal
Ranga Reddy Dist
Hyderabad
ANDHRA PRADESH
500078
India |
| Phone |
04023751346 |
| Fax |
|
| Email |
jayanthi@uniquebiotech.com |
|
|
Source of Monetary or Material Support
|
| Unique Biotech Limited
Plot No. 2, Phase-II,
Alexandria Knowledge Park
Kolthur Village, Shameerpet Mandal
Ranga Reddy Dist
Hyderabad-500 078
India.
|
|
|
Primary Sponsor
|
| Name |
Unique Biotech Ltd |
| Address |
Unique Biotech Limited
Plot No. 2, Phase-II,
Alexandria Knowledge Park
Kolthur Village, Shameerpet Mandal
Ranga Reddy Dist
Hyderabad-500 078
India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 A K Verma |
KRM Hospital & Research Centre |
Department of Pediatrics
First Floor, Room No 01
3/92-93
Vijayant Khand
Lucknow
Lucknow
UTTAR PRADESH |
9839089844
krmhrclko@gmail.com |
| Dr D C Pandey |
M V Hospital and Research Centre |
Department of Pediatrics
First Floor, Room No 01
314/30 Mirza Mandi Chowk
Lucknow
Lucknow
UTTAR PRADESH |
9415156419
mvhrclko@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Commitee at KRM Hospital |
Approved |
| Institutional Ethics Committee for MV Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Diarrhoea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus clausii UBBC07 ( BACIPRO) Oral Suspension |
Bacillus clausii ( BACIPRO) Oral Suspension containing
Bacillus clausii UBBC07 - 2 billion cfu/ 5ml suspension
Dosage: 5ml twice daily for 5 days
|
| Comparator Agent |
PLACEBO suspension |
PLACEBO suspension without active ingredient Bacillus clausii UBBC07
Dosage: Placebo suspension 5ml twice daily for 5 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged between ≥6 months and ≤5 years
2.Subjects with clinical diagnosis of acute
diarrhoea.
3.Subjects who experienced more than 3 loose stools in the last 24 hours
4.Subjects with no major illness.
5.Parents of the subjects willing to give written informed Consent & willing to follow study procedures.
6.Informed Consent form signed by the subject’s parent/Legally Acceptable Representative or an impartial witness
|
|
| ExclusionCriteria |
| Details |
1.Children with severe malnutrition (weight for height < 3 SD of WHO charts).
2.Subjects requiring antibiotics during the study period.
3.Presence of severe diarrhoea which, in the opinion of the investigator, requires treatment other than investigational product and ORS.
4. Presence of visible blood in the stool.
5.Use of probiotics in the previous three weeks, use of antibiotics or any antidiarrhoeal medication in the previous three weeks.
6.Participated in any clinical trial or used any investigational product in the past 90 days.
7.Known or expected hypersensitivity to any of the active substances or excipients.
8.Previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Number and Frequency of diarrhoea episodes post-therapy.
2) Duration of diarrhoea episodes post-therapy
1) Number and Frequency of diarrhoea episodes post-therapy.
2) Duration of diarrhoea episodes post-therapy.
3) Consistency of stool
|
Baseline, 5th day, 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Clinical Global Impression-Improvement (CGI-I) by Investigator.
2) Number, frequency and duration of vomiting episodes
3) Number of Fever episodes.
4)Assessment of gut microbiota before and after treatment with probiotic
5)Number and frequency of hospital admissions required
|
Baseline, 5th day, 10th day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "119"
Final Enrollment numbers achieved (India)="119" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/09/2017 |
| Date of Study Completion (India) |
09/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective,
double-blind, multicentric, randomized, parallel-group study to evaluate the
comparable safety and efficacy of Bacillus
clausii UBBC07 suspension (2 billion cfu/5 mL)
over placebo for treatment of acute diarrhoea in children of age six months to
five years. In all, 120 subjects will be randomized by block
randomization technique in order to enroll subjects in a targeted ratio of 1:1
(test: placebo). Test group and placebo group will have approximately equal
number of subjects in the age groups of 6 months to 5 years. Subjects who had
experienced >3 loose stools in last 24 hours will be randomized to receive
either test or placebo product. The IP will be administered for a period of
five days.
Subjects will be evaluated
for the frequency and duration of diarrhoea,
consistency of stools (primary efficacy parameters), vomiting, fever and any
hospital admissions required and on Clinical Global
Impression-Improvement (CGI-I) scale by the investigator and assessment of gut
microbiota before and after treatment with probiotic (secondary parameters).
Stool consistency will be
assessed by Bristol Stool Form scale which categorizes the stool in to seven
types. CGI-I will be evaluated on the 7-point scale. |