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

NCT ID: NCT01596829

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

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.

Conditions

Antibiotic-associated Diarrhoea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Probiotic consumption during and after course of antibiotic

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks

Placebo

Placebo consumed during and after course of antibiotic

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator

Interventions

Probiotic

Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Howaru Restore; Microcrystalline cellulose as placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danisco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toivo Piippo, MD

Role: PRINCIPAL_INVESTIGATOR

Koskiklinikka Tampereen Lääkärikeskus Oy

Anneli Tarpila, PhD

Role: STUDY_CHAIR

Danisco

Locations

Koskiklinikka

Tampere, , Finland

Countries

Finland

References

Forssten SD, Yeung N, Ouwehand AC. Fecal Recovery of Probiotics Administered as a Multi-Strain Formulation during Antibiotic Treatment. Biomedicines. 2020 Apr 9;8(4):83. doi: 10.3390/biomedicines8040083.

Reference Type: DERIVED

PMID: 32283645 (View on PubMed)

Other Identifiers

2012-001542-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AAD-EU2012

Identifier Type: -

Identifier Source: org_study_id