| CTRI Number |
CTRI/2018/01/011635 [Registered on: 31/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effectiveness of Bacillus coagulans LBSC in the Treatment of Acute Diarrhea with Abdominal Discomfort and Flatulence. |
|
Scientific Title of Study
|
“A Prospective, Interventional, Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus coagulans LBSC in the Treatment of Acute Diarrhea with Abdominal Discomfort and Flatulence.’’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/AETL/1117/78 Version: 01 Dated: 07 Dec 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadanand CD |
| Designation |
General Physician |
| Affiliation |
Rajalakshmi Multispeciality Hospital |
| Address |
Department of General Medicine 21/1, Lakshmipura Main Road, Vidyaranyapura.
Bangalore
KARNATAKA
560097
India |
| Phone |
09895183173 |
| Fax |
|
| Email |
drsadanand6@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
KARNATAKA
560097
India |
| Phone |
9900111997 |
| 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
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Advanced Enzymes Technologies Ltd 5TH Floor, A-Wing, Sun Magnetica, LIC Service Road Louiswadi, Thane (W) - 400 604, India |
|
|
Primary Sponsor
|
| Name |
Advanced Enzymes Technologies Ltd |
| Address |
5TH Floor, A-Wing, Sun Magnetica, LIC Service Road
Louiswadi, Thane (W) - 400 604, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadanand CD |
Rajalakshmi Multispeciality Hospital |
General medicine Department 21/1, Lakshmipura Main Road, Vidyaranyapura
Bangalore
KARNATAKA |
09895183173
drsadanand6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Instiutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, , Acute Diarrhea with Abdominal Discomfort and Flatulence., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactic Acid Bacillus |
Pharmaceutical form: Powder
Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water; twice-thrice daily prior to meal. |
| Comparator Agent |
Placebo |
Pharmaceutical form:Powder, Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water; twice-thrice daily prior to meal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and females aged more than 18 and less than 65 years completed years (both inclusive) with symptoms of acute diarrhea manifesting within 48 hours prior to entering the trial.
2. Subject having experienced at least three incidences of unformed stool (Type 7 by Bristol Stool form scale) within 48 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container)
3. Subjects must have complaints of abdominal discomfort caused by gastrointestinal gas accumulation within the last hour
4. Written informed consent by study participants
|
|
| ExclusionCriteria |
| Details |
1. Subjects requiring hospitalization for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis
2. Subjects with bloody or purulent stool
3. Subjects having erythrocytes or leukocytes in the stool at more than 3 per high power field
4. Subjects having an axillary temperature greater than 38.2 degrees Celsius (C) or an oral temperature more than 38.6 degrees C
5. Subjects having other symptoms of septicemia.
6. Subjects unable to take medication orally or tolerate oral rehydration
7. Participant having a systolic blood pressure less than 90 millimeter of mercury (mmHg) and or diastolic blood pressure less than 60 mmHg in sitting posture
8. Subjects have gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding and GERD.
9. Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations within 1 week before initiating study IP therapy;
10. Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy
11. Autoimmune gastritis
12.History of intubations for co morbidities (Chronic Lung Disease (CLD), Congenital Heart Defects (CHD), or neurologic disorders)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time To Last Unformed Stool (TTLUS)
2. Number of unformed stools produced from first IP administration to the end of treatment.
3. Change in severity of abdominal pain within 24 hours of starting the IP
4. Time to complete resolution of abdominal discomfort
5.Percentage change responders as defined by the number of subjects with complete remission of diarrhea within 48 hours
6. Number of subjects reporting reoccurrence of diarrhea symptoms within 120 hours
|
Screening to End of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Quality of life
2. Assessment for safety
3. Assessment of rate of incidence of AE and SAE’s
|
Screening to End of Treatment |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/01/2018 |
| Date of Study Completion (India) |
11/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A prospective Interventional Randomised Double Bl;ind Placebo controlled Clinical Study to Evaluate the Efficacy and safety of Bacillus coagulans LBSC in the treatment of Acute Diarrhea with Abdominal Discomfort and Flatulence.
Total Number of 72 Subjects.
Purpose of the study : To evaluate the efficacy and Safety of Bacillus coagulans LBSC in the treatment of Acute Diarrhea with Abdominal Discomfort and Flautlence.
|