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

Primary Purpose

Antibiotic-associated Diarrhoea

Status

Terminated

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Probiotic

Placebo

About this trial

This is an interventional supportive care trial for Antibiotic-associated Diarrhoea focused on measuring antibiotic, probiotic, antibiotic-associated diarrhoea, faecal microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Koskiklinikka

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Probiotic consumption during and after course of antibiotic

Placebo consumed during and after course of antibiotic

Outcomes

Primary Outcome Measures

Incidence of AAD

Incidence of diarrhoea defined as three or more loose or watery stools per a 24 h period.

Secondary Outcome Measures

Duration of diarrhoea

Number of continuous days of diarrhoea

Fecal microbiota

Analysis of overall microbiota from all samples and of causative diarrhoeal agent from samples taken during diarrhoeal episode

Safety profile

Evaluation of serious and non-serious adverse events

Full Information

NCT ID

NCT01596829

First Posted

May 8, 2012

Last Updated

January 21, 2016

Sponsor

Danisco

1. Study Identification

Unique Protocol Identification Number

NCT01596829

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Why Stopped

low incidence

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antibiotic-associated Diarrhoea

Keywords

antibiotic, probiotic, antibiotic-associated diarrhoea, faecal microbiota

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

258 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Active Comparator

Arm Description

Probiotic consumption during and after course of antibiotic

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo consumed during and after course of antibiotic

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic

Other Intervention Name(s)

Howaru Restore

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Microcrystalline cellulose as placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of AAD

Description

Incidence of diarrhoea defined as three or more loose or watery stools per a 24 h period.

Time Frame

Up to 21 days

Secondary Outcome Measure Information:

Title

Duration of diarrhoea

Description

Number of continuous days of diarrhoea

Time Frame

Up to 21 days

Title

Fecal microbiota

Description

Analysis of overall microbiota from all samples and of causative diarrhoeal agent from samples taken during diarrhoeal episode

Time Frame

Up to 21 days

Title

Safety profile

Description

Evaluation of serious and non-serious adverse events

Time Frame

Up to 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toivo Piippo, MD

Organizational Affiliation

Koskiklinikka Tampereen Lääkärikeskus Oy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anneli Tarpila, PhD

Organizational Affiliation

Danisco

Official's Role

Study Chair

Facility Information:

Facility Name

Koskiklinikka

City

Tampere

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Terminated prematurely.

Citations:

PubMed Identifier

32283645

Citation

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.

Results Reference

derived

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

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