- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01596829
Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea
January 21, 2016 updated by: Danisco
Antibiotic treatment disturbs the balance of the intestinal microbiota and predisposes to antibiotic associated diarrhea.
Previous studies have shown that the risk of developing diarrhea during a course of antibiotics may be reduced by simultaneous consumption of probiotics.
The aim of the present study is to assess the effect of a probiotic formula containing four strains on reducing the risk of antibiotic associated diarrhea.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to assess the effect of a probiotic formula on reducing the risk of antibiotic-associated diarrhea (AAD).
The study will be conducted as a two-arm, parallel groups, placebo-controlled, double-blind, randomized clinical trial, stratified by age, gender and number of days on antibiotics.
The duration of patient participation in the study will be up to 7 weeks (up to 3 weeks supplementation, 4 weeks follow-up).
The overall duration of the study is expected to be approximately 8 months.
Adult males and females that are prescribed antibiotic therapy for minimum of 3 and a maximum of 14 days will be included in the study.
The incidence of AAD will be evaluated as the primary end-point.
The stool from patients presenting diarrhea will be tested for the presence of Clostridium difficile and if negative for C. difficile, also for the presence of other common pathogens causing diarrhea.
The overall microbiota will be analyzed from fecal samples taken regularly during each phase of the study.
Study Type
Interventional
Enrollment (Actual)
258
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tampere, Finland
- Koskiklinikka
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females aged 18-65 years.
- Patients will be initiating antibiotic therapy.
- The antibiotic therapy consists of one of the following: broad spectrum penicillins, cephalosporins, doxycycline, clarithromycin, ciprofloxacin or isoxazolyl penicillin.
- The antibiotic therapy is expected to be 3 to 14 days in duration.
- Obtained his/her informed consent after verbal and written information.
- Have a high probability for compliance with and completion of the study.
- Patients having a telephone available.
- Body Mass Index between 19 and 30.
Exclusion Criteria:
- Participation in a clinical trial with an investigational product or drug within the 60 days prior to screening.
- Likeliness to be noncompliant with the protocol, or to be unsuitable to the study by the investigator for any reason.
- Pregnant or breastfeeding women; women planning to become pregnant during the study months.
- Presence of active diarrhea (3 or more loose or watery stools per 24 hour period).
- Daily consumption of probiotics, fermented milk and/or yogurt with probiotics.
- Known to have a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. on-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetable source), ascorbic acid, Colloidal silicon dioxide).
- Presence of an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis.
- Regular use of proton pump inhibitors.
- Bowel surgery, artificial heart valve, history of rheumatic heart disease or infective endocarditis.
- A previous documented C. difficile infection < 3 months prior to study initiation.
- Immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, AIDS).
- Ongoing or recent use of antibiotic therapy in the 3 months prior to the study product first administration.
- Planned administration of antibiotics other than broad spectrum penicillins, cephalosporins, doxycycline, ciprofloxacin or isoxazolyl penicillin for the treatment of an infection.
- History of drug or alcohol abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Probiotic
Probiotic consumption during and after course of antibiotic
|
Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Placebo consumed during and after course of antibiotic
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A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of AAD
Time Frame: Up to 21 days
|
Incidence of diarrhoea defined as three or more loose or watery stools per a 24 h period.
|
Up to 21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of diarrhoea
Time Frame: Up to 21 days
|
Number of continuous days of diarrhoea
|
Up to 21 days
|
Fecal microbiota
Time Frame: Up to 21 days
|
Analysis of overall microbiota from all samples and of causative diarrhoeal agent from samples taken during diarrhoeal episode
|
Up to 21 days
|
Safety profile
Time Frame: Up to 21 days
|
Evaluation of serious and non-serious adverse events
|
Up to 21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Toivo Piippo, MD, Koskiklinikka Tampereen Lääkärikeskus Oy
- Study Chair: Anneli Tarpila, PhD, Danisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
May 8, 2012
First Submitted That Met QC Criteria
May 9, 2012
First Posted (ESTIMATE)
May 11, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 22, 2016
Last Update Submitted That Met QC Criteria
January 21, 2016
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAD-EU2012
- 2012-001542-18 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Terminated prematurely.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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