Antibiotic-associated DiarrheaNCT02722993
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
A study testing Probiotics in people with Antibiotic-associated Diarrhea, run by Probi AB at 1 site in Poland.
Trial summary
To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following 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 Diarrhea
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 sitePoland
- Study dates
- 3 Feb 2016to 8 May 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children at the age of 1-11 years that have been prescribed antibiotic treatment.
- Problems with loose stools during earlier antibiotic treatments.
- Children whose parents or legal caregivers have signed the informed consent to participate in the study.
Who cannot join
- Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
- Chronic or acute diarrheal disease.
- Use of laxatives the week before inclusion in the study.
- Antibiotic treatment for the last four weeks before inclusion in the study.
- Intake of probiotic products for the last two weeks before inclusion in the study.
- Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (potato starch ± bacterial culture that may contain traces of soy).
- Patient requiring hospitalisation.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- Probiotics, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Not described Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of loose/watery stools
Measured: 19-26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start3 Feb 2016
- Primary completion8 May 2017
- Study completion8 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-associated DiarrheaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Socha, Prof., Principal investigator, Children's Memorial Health Institute, Warzaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722993
- Sponsor's protocol ID
- ProGastro Kids 16
- Status last verified
- Sep 2018
- First submitted
- 16 Mar 2016
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT02722993
- Acronym / sponsor ID
- ProGastro Kids 16
- Conditions
- Antibiotic-associated Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 8 May 2017 (actual)
- First posted
- 30 Mar 2016 (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 effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following 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: Probiotics |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children at the age of 1-11 years that have been prescribed antibiotic treatment.
- Problems with loose stools during earlier antibiotic treatments.
- Children whose parents or legal caregivers have signed the informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
- Chronic or acute diarrheal disease.
- Use of laxatives the week before inclusion in the study.
- Antibiotic treatment for the last four weeks before inclusion in the study.
- Intake of probiotic products for the last two 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 |
|---|---|---|
| Probiotics | Dietary supplement | Probiotics |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Number of loose/watery stools
Time frame: 19-26 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 26 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Piotr Socha, Prof. principal investigator
Children's Memorial Health Institute, Warzaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Antibiotic-associated Diarrhea, 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 7 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 26 Sep 2018. 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.
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?
Number of loose/watery stools (time frame: 19-26 days). 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 26 Sep 2018.