Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000384954
Ethics application status
Approved
Date submitted
12/04/2011
Date registered
13/04/2011
Date last updated
13/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Providac techsules for prevention of Antibiotic-Associated Diarrhea
Scientific title
Randomized placebo-controlled, double blind, Multicentric Trial on Efficacy and Safety of Providac techsules (Lactobacillus acidophilus LA-5 and Bifidobacterium BB -12) for prevention of Antibiotic-Associated Diarrhea in Indian patients
Secondary ID [1] 259987 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antibiotic-Associated Diarrhea 265611 0
Condition category
Condition code
Oral and Gastrointestinal 265762 265762 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Orally administered Providac capsules (Lactobacillus acidophilus LA5, 500 million Colony Forming Units & Bifidobacterium BB12, 500 million Colony Forming Units) twice daily or placebo treatment, taken twice daily (alongwith antibiotic therapy commencement) after food for 14 days and followed up during this period of 14 days (at day 7 and day 14 following study medication commencement). A special name assigned to specially designed capsules-Techsules. These are Technologically innovated capsules that ensure targeted delivery of probiotics.
Intervention code [1] 264400 0
Prevention
Intervention code [2] 264402 0
Treatment: Drugs
Comparator / control treatment
Placebo-Glucose anhydrate and magnesium stearate
Control group
Placebo

Outcomes
Primary outcome [1] 266517 0
Incidence of antibiotic associated diarrhea in a subject symptom diary
Timepoint [1] 266517 0
14 days
Secondary outcome [1] 273938 0
Duration of diarrhea in a subject symptom diary
Timepoint [1] 273938 0
14 days

Eligibility
Key inclusion criteria
adult patients who received oral systemic oral antibiotic therapy [cefadroxil or amoxicillin] for at least 5 days
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who had completed a course of systemic antibiotic in the last 7 days prior to screening.
2. Severe infection requiring hospitalization or parenteral antibiotic therapy
3. Pregnancy and/or lactation.
4. Patients who were debilitated or seriously ill or immunocompromised
5. Patients with acute infective diarrhea, septicaemia, endocarditis, uncontrolled diabetes or any malignancy
6. Patients with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohn’s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhea and functional constipation.
7. Patients with hepatic and / or renal insufficiency.
8. Patients with unstable hyperthyroidism or hypothyroidism.
9. Patients who have undergone ileostomy, jejunostomy or colostomy.
10. Patient undergoing active radiotherapy or chemotherapy.
11. Current use of any drugs or treatments which is supposed to decrease the gastrointestinal motility or any other concomitant anti-diarrheal medication.
12. Patients with hypersensitivity to any ingredient in the formulation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 3381 0
India
State/province [1] 3381 0

Funding & Sponsors
Funding source category [1] 264865 0
Commercial sector/Industry
Name [1] 264865 0
Zydus Alidac,Cadila Healthcare Limited,
Country [1] 264865 0
India
Primary sponsor type
Commercial sector/Industry
Name
Zydus Alidac,Cadila Healthcare Limited,
Address
Zydus Tower, Satellite Cross Roads,Ahmedabad – 380015
Country
India
Secondary sponsor category [1] 263967 0
Commercial sector/Industry
Name [1] 263967 0
Chr.Hansen
Address [1] 263967 0
M/s Chr. Hansen, A/S, Avedoere,1-27, Jernholmen,2650 Hvidovre, Denmark
Country [1] 263967 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266830 0
IEC
Ethics committee address [1] 266830 0
Institute of Postgraduate Medical Education & Research and SSKM Hospital, Kolkata
Ethics committee country [1] 266830 0
India
Date submitted for ethics approval [1] 266830 0
Approval date [1] 266830 0
Ethics approval number [1] 266830 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32477 0
Address 32477 0
Country 32477 0
Phone 32477 0
Fax 32477 0
Email 32477 0
Contact person for public queries
Name 15724 0
Dr Amit Bhalla
Address 15724 0
Zydus Alidac,Cadila Healthcare Limited, Zydus Tower, Satellite Cross Roads,Ahmedabad – 380015
Country 15724 0
India
Phone 15724 0
+917926868543
Fax 15724 0
Email 15724 0
[email protected]
Contact person for scientific queries
Name 6652 0
Dr Amit Bhalla
Address 6652 0
Zydus Alidac,Cadila Healthcare Limited, Zydus Tower, Satellite Cross Roads,Ahmedabad – 380015
Country 6652 0
India
Phone 6652 0
+917926868543
Fax 6652 0
Email 6652 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.