Changes in the Gut Microbiota During an Antibiotic TreatmentNCT03523936
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
A study testing Prebiotic product in people with Changes in the Gut Microbiota During an Antibiotic Treatment, run by Turku University Hospital.
Trial summary
Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Changes in the Gut Microbiota During an Antibiotic Treatment
- What is being tested?
- Prebiotic product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 31 Dec 2019
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- An infection requiring antibiotic treatment assessed by a doctor
Who cannot join
- Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study
Trial locations and contacts
No sites are listed yet.
About this study
Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.
Read the detailed description
Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment.
The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.
- Being tested
- Prebiotic product, Placebo
- Keywords
- antibiotics, prebiotics, dysbiosis
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic productDietary supplement
Prebiotic product used during the course of antibiotic treatment
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Active comparator | Not described Receives: Dietary Supplement: Prebiotic product |
| 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.
Changes of gut microbiota during antibiotic treatment
Gut microbiota and antibiotics - Prevention of side effects by new prebiotics
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in the Gut Microbiota During an Antibiotic TreatmentStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Model description
- Double blind placebo controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- VTT Technical Research Centre of Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523936
- Sponsor's protocol ID
- T63/2018
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
- ClinicalTrials.gov ID
- NCT03523936
- Acronym / sponsor ID
- T63/2018
- Keywords
- antibiotics, prebiotics, dysbiosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- VTT Technical Research Centre of Finland
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 May 2018 (actual)
- 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.
Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.
Detailed description
Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment.
The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Double blind placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Active comparator | Dietary Supplement: Prebiotic product |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- An infection requiring antibiotic treatment assessed by a doctor
Key exclusion criteria (1 listed)
- Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during 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 |
|---|---|---|
| Prebiotic productPrebiotic product used during the course of antibiotic treatment | Dietary supplement | Prebiotic |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Changes of gut microbiota during antibiotic treatment
Time frame: One week
Gut microbiota and antibiotics - Prevention of side effects by new prebiotics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic product in people with Changes in the Gut Microbiota During an Antibiotic Treatment, run by Turku University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seppo salminen, PhD (+35823336880, sepsal@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of gut microbiota during antibiotic treatment (time frame: One week). 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 14 May 2018.