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Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Danisco
Sponsor:
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01596829
First received: May 8, 2012
Last updated: April 10, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Danisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Males and females aged 18-65 years.
  2. Patients will be initiating antibiotic therapy.
  3. The antibiotic therapy consists of one of the following: broad spectrum penicillins, cephalosporins, doxycycline, clarithromycin, ciprofloxacin or isoxazolyl penicillin.
  4. The antibiotic therapy is expected to be 3 to 14 days in duration.
  5. Obtained his/her informed consent after verbal and written information.
  6. Have a high probability for compliance with and completion of the study.
  7. Patients having a telephone available.
  8. Body Mass Index between 19 and 30.

Exclusion Criteria:

  1. Participation in a clinical trial with an investigational product or drug within the 60 days prior to screening.
  2. Likeliness to be noncompliant with the protocol, or to be unsuitable to the study by the investigator for any reason.
  3. Pregnant or breastfeeding women; women planning to become pregnant during the study months.
  4. Presence of active diarrhea (3 or more loose or watery stools per 24 hour period).
  5. Daily consumption of probiotics, fermented milk and/or yogurt with probiotics.
  6. 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).
  7. Presence of an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis.
  8. Regular use of proton pump inhibitors.
  9. Bowel surgery, artificial heart valve, history of rheumatic heart disease or infective endocarditis.
  10. A previous documented C. difficile infection < 3 months prior to study initiation.
  11. Immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, AIDS).
  12. Ongoing or recent use of antibiotic therapy in the 3 months prior to the study product first administration.
  13. Planned administration of antibiotics other than broad spectrum penicillins, cephalosporins, doxycycline, ciprofloxacin or isoxazolyl penicillin for the treatment of an infection.
  14. History of drug or alcohol abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596829

Contacts
Contact: Anna-Mari Ahlfors anna-mari.ahlfors@tfscro.com
Contact: Anneli Tarpila, PhD anneli.tarpila@danisco.com

Locations
Finland
Koskiklinikka Recruiting
Tampere, Finland
Principal Investigator: Toivo Piippo, MD         
Sponsors and Collaborators
Danisco
Investigators
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
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014