Antibiotic TherapyPhase 2NCT01667653
Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
A Phase 2 study testing Probiotic in people with Antibiotic Therapy, run by Danisco at 1 site in Canada.
Trial summary
This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Therapy
- 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
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Aug 2012
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 50 years.
- Healthy as determined by laboratory results, medical history and physical exam
- Willing to give voluntary, written, informed consent to participate in the study
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Body mass index ≥ 30 kg/m2
- Average number of formed bowel movements > 3 per day or < 3 per week
- Smokers
- Participation in a clinical research trial within 30 days prior to randomization
- Use of antibiotics within 60 days prior to randomization.
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- Habitual use of pro- and/or prebiotic products.
- Follows a vegetarian or vegan diet
- Unstable medical conditions
- Any evidence of acute or chronic gastrointestinal disorder
- Alcohol use > 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year
- Allergy or sensitivity to test product ingredients or antibiotic
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.
- Conditions
- Antibiotic Therapy
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic capsule once daily
PlaceboDietary supplement
Placebo capsule once daily
| Study group | Role | What they receive |
|---|---|---|
| Augmentin/Probiotic | Experimental | Participants are provided in double blinded fashion probiotic to take with antibiotics Receives: Dietary Supplement: Probiotic |
| Augmentin/placebo | Experimental | Participants are provided in double blinded fashion placebo to take with antibiotics Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg
Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR.
Measured: 3 weeks
Secondary outcomes (1)
The influence of probiotics on side effects associated with antibiotic use
Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects,
Measured: 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic TherapyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667653
- Sponsor's protocol ID
- 11PDHD
- Status last verified
- Aug 2012
- First submitted
- 23 Mar 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT01667653
- Acronym / sponsor ID
- 11PDHD
- Conditions
- Antibiotic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Aug 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.
This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmentin/Probiotic | Experimental | Dietary Supplement: ProbioticParticipants are provided in double blinded fashion probiotic to take with antibiotics |
| Augmentin/placebo | Experimental | Dietary Supplement: PlaceboParticipants are provided in double blinded fashion placebo to take with antibiotics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female aged 18 to 50 years.
- Healthy as determined by laboratory results, medical history and physical exam
- Willing to give voluntary, written, informed consent to participate in the study
Key exclusion criteria (13 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Body mass index ≥ 30 kg/m2
- Average number of formed bowel movements > 3 per day or < 3 per week
- Smokers
- Participation in a clinical research trial within 30 days prior to randomization
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 |
|---|---|---|
| ProbioticProbiotic capsule once daily | Dietary supplement | Augmentin/Probiotic |
| PlaceboPlacebo capsule once daily | Dietary supplement | Augmentin/placebo |
Primary outcome
Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg
Time frame: 3 weeks
Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR.
1 secondary outcome
The influence of probiotics on side effects associated with antibiotic use
Time frame: 3-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Antibiotic Therapy, run by Danisco at 1 site in Canada.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 17 Aug 2012. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2012.