Antibiotic-associated Loose/Watery StoolsPhase 2NCT01940913
Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.
A Phase 2 study testing Probiotic capsules in people with Antibiotic-associated Loose/Watery Stools, run by Probi AB at 1 site in Poland.
Trial summary
To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Antibiotic-associated Loose/Watery Stools
- What is being tested?
- Probiotic capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2013to May 2014
- 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 1 year to 11 years
- All sexes
- Child
Who may be able to join
- Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
- Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
- Children whose parents or legal caregivers have signed the informed consent to participate in the study.
Who cannot join
- Chronic intestinal disease.
- Current immunodeficiency or immunosuppressive treatment.
- Chronic or acute diarrhoeal disease.
- Use of laxatives the week before inclusion in the study.
- Antibiotic treatment for the last four weeks before inclusion in the study.
- Known hypersensitivity to any of the ingredients in the probiotic product or the placebo [potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture].
- Intake of any probiotic products for the last two weeks before inclusion in the study.
- Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.
- Being tested
- Probiotic capsules, Placebo capsules
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic capsulesDietary supplement
Placebo capsulesDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Not described Receives: Dietary Supplement: Probiotic capsules |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the incidence of loose/watery stools following antibiotic treatment in children.
Measured: 19-24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionMay 2014
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 Loose/Watery StoolsStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940913
- Sponsor's protocol ID
- ProAAD
- Status last verified
- May 2014
- First submitted
- 9 Sep 2013
- Last updated
- 9 May 2014
- Results posted
- No
Publications
Olek A, Woynarowski M, Ahren IL, Kierkus J, Socha P, Larsson N, Onning G. Efficacy and Safety of Lactobacillus plantarum DSM 9843 (LP299V) in the Prevention of Antibiotic-Associated Gastrointestinal Symptoms in Children-Randomized, Double-Blind, Placebo-Controlled Study. J Pediatr. 2017 Jul;186:82-86. doi: 10.1016/j.jpeds.2017.03.047. Epub 2017 Apr 21.
PubMed 28438377
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.
- ClinicalTrials.gov ID
- NCT01940913
- Acronym / sponsor ID
- ProAAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Sep 2013 (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.
To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.
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 |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: Probiotic capsules |
| Placebo | Placebo comparator | Dietary Supplement: Placebo capsules |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
- Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
- Children whose parents or legal caregivers have signed the informed consent to participate in the study.
Key exclusion criteria (8 listed)
- Chronic intestinal disease.
- Current immunodeficiency or immunosuppressive treatment.
- Chronic or acute diarrhoeal disease.
- Use of laxatives the week before inclusion in the study.
- Antibiotic treatment for the last four weeks before inclusion in the study.
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 |
|---|---|---|
| Probiotic capsules | Dietary supplement | Probiotics |
| Placebo capsules | Dietary supplement | Placebo |
Primary outcome
Reduction of the incidence of loose/watery stools following antibiotic treatment in children.
Time frame: 19-24 days
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 9 May 2014.
- Derived from this study: PubMed 28438377Olek A, Woynarowski M, Ahren IL, Kierkus J, Socha P, Larsson N, Onning G. Efficacy and Safety of Lactobacillus plantarum DSM 9843 (LP299V) in the Prevention of Antibiotic-Associated Gastrointestinal Symptoms in Children-Randomized, Double-Blind, Placebo-Controlled Study. J Pediatr. 2017 Jul;186:82-86. doi: 10.1016/j.jpeds.2017.03.047. Epub 2017 Apr 21.
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 capsules in people with Antibiotic-associated Loose/Watery Stools, run by Probi AB at 1 site in Poland.
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 8 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 9 May 2014. 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 Poland. 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 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?
Reduction of the incidence of loose/watery stools following antibiotic treatment in children. (time frame: 19-24 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 NCT01940913, 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 9 May 2014.