| CTRI Number |
CTRI/2020/03/023936 [Registered on: 13/03/2020] Trial Registered Prospectively |
| Last Modified On: |
24/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii (probiotic) in the Treatment of Antibiotic Associated Diarrhoea |
|
Scientific Title of Study
|
A Prospective, interventional, randomized, double blind, parallel, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii 088AE in the Treatment of Antibiotic-Associated Diarrhoea. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/AETL/1022/98 version 01 dated 22 Oct 2019 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Giriraja K V |
| Designation |
General physician |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Lakshmipura main road, Vidyaranyapura bengalore 560097
Bangalore
KARNATAKA
560097
India |
| Phone |
9738877298 |
| Fax |
|
| Email |
drgirirajkv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd |
| Address |
#16 & 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore 560 097
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd |
| Address |
#16 & 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore 560 097
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Advanced Enzyme Technologies Ltd |
|
|
Primary Sponsor
|
| Name |
Advanced Enzyme Technologies Ltd |
| Address |
A 135 Road No. 23 Wagle Industrial estate
Thane W 400 604
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Giriraja K V |
Rajalakshmi Hospital |
Lakshmipura main road, Vidyaranyapura
bengalore 560097
Bangalore
KARNATAKA |
9738877298
drgirirajkv@gmail.com |
| Dr Prashant Sadashiv Deshmukh |
Sai hospital pune |
Near Hanuman Mandir, Gangai Chamber, Main Road Akurdi, Pune - 411035.
Pune
MAHARASHTRA |
8805986199
Saihospitalpcmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital instituational ethics committee |
Approved |
| ROYAL PUNE INDEPENDEPENT ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Bacillus clausii 088AE |
6 Billion colony forming unit per day
2 Billion CFU per sachet daily three times
Infants and Children 2 sachet per day
Adults 3 sachet per day
Method of administration Oral
Treatment duration will be 7 days |
| Comparator Agent |
Placebo |
6 Billion colony forming unit per day 2 Billion CFU per sachet daily three times Infants and Children 2 sachet per day Adults 3 sachet per day Method of administration Ora. Treatment duration will be 7 days |
|
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Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and females aged >2 and <65 years completed years (both inclusive) with symptoms of antibiotic treatment induced diarrhea manifesting within at least 48 hours or more than prior to entering the trial
2.Patients having experienced at least three incidences of unformed stool (Type 7 by Bristol Stool form scale) within at least 48 hours or more than prior to entering the trial
3.Patients with diarrhea induced due to ongoing antibiotic therapy (Patients should be on the initial 4 days of antibiotic therapy which is given for at least for 14 days
4.Patient must have complaints of related gastrointestinal disorders caused by various abdominal discomforts within the last hour
5.Willing to give written informed consent or assent form by study participants or parent wherever applicable.
|
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| ExclusionCriteria |
| Details |
1.Patients with bloody or purulent stool, with pus or mucus.
2.Severe dehydration needing hospitalization.
3.An axillary temperature greater than (>) 38.2°C or an oral temperature > 38.6°C
4.Symptoms of septicemia (Fever, shivering, or feeling cold, fast heart rate, fast breathing and shortness of breath, sweaty or clammy skin, etc.)
5.Unable to take medication orally or tolerate oral rehydration.
6.Taken probiotics prior to study (2 weeks) or during study other than interventional product.
7.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.
8.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations within 1 week before initiating study IP therapy.
9.Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.
10.History of intubations for co-morbidities (chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders.
11.Use of any investigational drug currently or within 30 days prior to study entry.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time to Last Unformed Stool (TTLUS) – At 24 h, 72 h, 120 h, 168 h & End.
2.Number of unformed stools at time points - At 24 h, 72 h, 120 h, 168 h & End – starting from first IP administration.
3.Time to complete resolution of functional gastrointestinal discomforts- At 24 h, 72 h, 120 h, 168 h & End
4.% responders as defined by the number of subjects with complete remission of diarrhea within 24 h, 72 h, 120 h, 168 h & End
|
screening to end of treatment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the changes of the severity of AAD related symptoms
2.To evaluate the changes in VAS score of AAD at 24 h, 72 h, 120 h, 168 h & End
3.Tolerance
4.Assessment of safety of the Investigational products
5.Adverse event
6.Physical examination
7. Biomarker of systemic safety
|
screening to end of treatment |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2020 |
| Date of Study Completion (India) |
07/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="17" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Prospective, Interventional, Randomized, Double blind, Parallel, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii 088AE in the Treatment of Antibiotic-Associated Diarrhoea.
Total 120 subjects 1. Placebo Pediatric AAD (n=30 randomized)
[Pediatric; Age group: 2-10 Years]
2. Test Pediatric AAD (n=30 randomized)
[Pediatric; Age group: 2-10 Years]
3. Placebo adolescent & Adult AAD (n=30 randomized)
[Adolescent & adult; Age group: 11-up to 65 Years]
4. Test adolescent & Adult AAD (n=30 randomized)
[Adolescent & adult; Age group: 11-up to 65 Years]
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