Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Antibiotic-associated Diarrhoea |
Dietary Supplement: Probiotic Dietary Supplement: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea |
- Incidence of AAD [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]Incidence of diarrhoea defined as three or more loose or watery stools per a 24 h period.
- Duration of diarrhoea [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]Number of continuous days of diarrhoea
- Fecal microbiota [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]Analysis of overall microbiota from all samples and of causative diarrhoeal agent from samples taken during diarrhoeal episode
- Safety profile [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]Evaluation of serious and non-serious adverse events
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Probiotic
Probiotic consumption during and after course of antibiotic
|
Dietary Supplement: Probiotic
Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks
Other Name: Howaru Restore
|
|
Placebo Comparator: Placebo
Placebo consumed during and after course of antibiotic
|
Dietary Supplement: Placebo
A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator
Other Name: Microcrystalline cellulose as placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Anna-Mari Ahlfors | anna-mari.ahlfors@tfscro.com | |
| Contact: Anneli Tarpila, PhD | anneli.tarpila@danisco.com |
| Finland | |
| Koskiklinikka | Recruiting |
| Tampere, Finland | |
| Principal Investigator: Toivo Piippo, MD | |
| Principal Investigator: | Toivo Piippo, MD | Koskiklinikka Tampereen Lääkärikeskus Oy |
| Study Chair: | Anneli Tarpila, PhD | Danisco |
More Information
No publications provided
| Responsible Party: | Danisco |
| ClinicalTrials.gov Identifier: | NCT01596829 History of Changes |
| Other Study ID Numbers: | AAD-EU2012, 2012-001542-18 |
| Study First Received: | May 8, 2012 |
| Last Updated: | April 10, 2013 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Danisco:
|
antibiotic probiotic antibiotic-associated diarrhoea faecal microbiota |
Additional relevant MeSH terms:
|
Diarrhea Signs and Symptoms, Digestive Signs and Symptoms Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013