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

This study has been terminated.
(low incidence)
Information provided by (Responsible Party):
Danisco Identifier:
First received: May 8, 2012
Last updated: January 21, 2016
Last verified: December 2014
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
    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 ]
    Number of continuous days of diarrhoea

  • 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

  • Safety profile [ Time Frame: Up to 21 days ]
    Evaluation of serious and non-serious adverse events

Enrollment: 258
Study Start Date: December 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01596829

Tampere, Finland
Sponsors and Collaborators
Principal Investigator: Toivo Piippo, MD Koskiklinikka Tampereen Lääkärikeskus Oy
Study Chair: Anneli Tarpila, PhD Danisco
  More Information

Responsible Party: Danisco Identifier: NCT01596829     History of Changes
Other Study ID Numbers: AAD-EU2012
2012-001542-18 ( EudraCT Number )
Study First Received: May 8, 2012
Last Updated: January 21, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Terminated prematurely.

Keywords provided by Danisco:
antibiotic-associated diarrhoea
faecal microbiota

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on April 21, 2017