Antibiotic-associated DiarrhoeaPhase 2/3NCT01596829
Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea
A Phase 2/3 study testing Probiotic in people with Antibiotic-associated Diarrhoea, run by Danisco at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antibiotic-associated Diarrhoea
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Probiotic, Placebo
- Keywords
- antibiotic, probiotic, antibiotic-associated diarrhoea, faecal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Howaru Restore
Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks
PlaceboDietary supplement
Also called Microcrystalline cellulose as placebo
A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic consumption during and after course of antibiotic Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo consumed during and after course of antibiotic Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AAD
Incidence of diarrhoea defined as three or more loose or watery stools per a 24 h period.
Measured: Up to 21 days
Secondary outcomes (3)
Duration of diarrhoea
Number of continuous days of diarrhoea
Measured: Up to 21 days
Fecal microbiota
Analysis of overall microbiota from all samples and of causative diarrhoeal agent from samples taken during diarrhoeal episode
Measured: Up to 21 days
Safety profile
Evaluation of serious and non-serious adverse events
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: low incidence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic-associated DiarrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toivo Piippo, MD, Principal investigator, Koskiklinikka Tampereen Lääkärikeskus OyAnneli Tarpila, PhD, Study chair, Danisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596829
- Sponsor's protocol ID
- AAD-EU2012
- Other IDs
- 2012-001542-18
- Status last verified
- Dec 2014
- First submitted
- 8 May 2012
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Terminated prematurely.
Publications
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.
PubMed 32283645
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea
- ClinicalTrials.gov ID
- NCT01596829
- Acronym / sponsor ID
- AAD-EU2012
- Conditions
- Antibiotic-associated Diarrhoea
- Keywords
- antibiotic, probiotic, antibiotic-associated diarrhoea, faecal microbiota
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low incidence
- Enrolment
- 258 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticProbiotic consumption during and after course of antibiotic |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo consumed during and after course of antibiotic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Howaru RestoreProbiotic formula, 10 billion CFU in total once a day for up to 3 weeks | Dietary supplement | Probiotic |
| PlaceboAlso: Microcrystalline cellulose as placeboA capsule with microcrystalline cellulose matching the appearance and taste of the active comparator | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
Duration of diarrhoea
Time frame: Up to 21 days
Fecal microbiota
Time frame: Up to 21 days
Safety profile
Time frame: Up to 21 days
Results and safety
The study was stopped early (reason given: low incidence). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Derived from this study: PubMed 32283645Forssten 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.
- Individual participant dataSharing planned: No. Terminated prematurely.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toivo Piippo, MD principal investigator
Koskiklinikka Tampereen Lääkärikeskus Oy
Anneli Tarpila, PhD study chair
Danisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Probiotic in people with Antibiotic-associated Diarrhoea, run by Danisco at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low incidence). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AAD (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.