Infectious DiseaseNCT03457688
Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children
A study testing prebiotic inulin-type fructans in people with Infectious Disease and Children, Only, run by Beneo-Institute.
Trial summary
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician in children. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, Children, Only, Diet Modification
- What is being tested?
- prebiotic inulin-type fructans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- No sites listed yet
- Study dates
- 19 Sep 2016to 1 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is healthy at the time of pre-examination
- Subject is aged 3-6 years at the time of pre-examination
- Subject attends a kindergarten at the time of pre-examination
Who cannot join
- Suffering from current infection or has suffered from infection in previous 7 days
- Intake of antibiotics and/or laxatives in the previous 14 days prior to start of the intervention
- children with known gastrointestinal disease or malformation
- children with congenital or acquired immunodeficiency
- children with food intolerance, food allergy
- children that regularly consume (more than 3 times per week) probiotic products or a food supplement containing prebiotics
- children involved in any clinical or food study within the preceding 6 months
About this study
Official title: Double-blind, Randomized Placebo-controlled, Multi-center Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Infectious Incidence in Children Aged 3 to 6 Years
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician in children.
- Conditions
- Infectious Disease, Children, Only, Diet Modification
- Being tested
- prebiotic inulin-type fructans, placebo maltodextrin
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prebiotic inulin-type fructansDietary supplement
placebo maltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| prebiotic inulin-type fructans | Active comparator | Not described Receives: Dietary Supplement: prebiotic inulin-type fructans |
| placebo maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: placebo maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of febrile infectious episodes diagnosed by paediatrician
Measured: 6 months period
Secondary outcomes (15)
Number of any infectious episodes diagnosed by paediatrician
Measured: 6 months period
Number of episodes with symptoms of illnesses indicating a viral or bacterial infection
Measured: 6 months period
Duration of febrile infectious episodes diagnosed by the paediatrician
Measured: 6 months period
Duration of any infectious episode
Measured: 6 months period
Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection
Measured: 6 months period
Days of absence from day-care of the child due to infectious episodes and/or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
Measured: 6 months period
Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
Measured: 6 months period
Hospitalization days due to infectious disease and/or symptoms of dysbiosis
Measured: 6 months period
Number of days (parents questionnaire and diary) of caretaker´s absenteeism from work due to infectious episodes and/or symptoms of dysbiosis of the child
Measured: 6 months period
Number of episodes on antibiotic treatment
Measured: 6 months period
Number of days on antibiotic treatment
Measured: 6 months period
Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
Measured: 6 months period
Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
Measured: 6 months period
Quality of life reported by the parents according to standardized questionnaire
Parent Diary (scale: no, minor, moderate, significant changes, Not known)
Measured: 6 months period
Analysis of stool samples in a subset of children: microbiota changes
Measured: 6 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start19 Sep 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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 Infectious DiseaseStudies 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
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamás Decsi, Prof., Principal investigator, Department of Paediatrics, University of Pécs, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457688
- Sponsor's protocol ID
- 16002n_
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lohner S, Kullenberg D, Antes G, Decsi T, Meerpohl JJ. Prebiotics in healthy infants and children for prevention of acute infectious diseases: a systematic review and meta-analysis. Nutr Rev. 2014 Aug;72(8):523-31. doi: 10.1111/nure.12117. Epub 2014 Jun 5.
PubMed 24903007
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Placebo-controlled, Multi-center Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Infectious Incidence in Children Aged 3 to 6 Years
- ClinicalTrials.gov ID
- NCT03457688
- Acronym / sponsor ID
- 16002n_
- Conditions
- Infectious Disease, Children, Only, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 7 Mar 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.
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician 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 |
|---|---|---|
| prebiotic inulin-type fructans | Active comparator | Dietary Supplement: prebiotic inulin-type fructans |
| placebo maltodextrin | Placebo comparator | Dietary Supplement: placebo maltodextrin |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject is healthy at the time of pre-examination
- Subject is aged 3-6 years at the time of pre-examination
- Subject attends a kindergarten at the time of pre-examination
Key exclusion criteria (7 listed)
- Suffering from current infection or has suffered from infection in previous 7 days
- Intake of antibiotics and/or laxatives in the previous 14 days prior to start of the intervention
- children with known gastrointestinal disease or malformation
- children with congenital or acquired immunodeficiency
- children with food intolerance, food allergy
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 inulin-type fructans | Dietary supplement | prebiotic inulin-type fructans |
| placebo maltodextrin | Dietary supplement | placebo maltodextrin |
Primary outcome
Number of febrile infectious episodes diagnosed by paediatrician
Time frame: 6 months period
15 secondary outcomes
Number of any infectious episodes diagnosed by paediatrician
Time frame: 6 months period
Number of episodes with symptoms of illnesses indicating a viral or bacterial infection
Time frame: 6 months period
Duration of febrile infectious episodes diagnosed by the paediatrician
Time frame: 6 months period
Duration of any infectious episode
Time frame: 6 months period
Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection
Time frame: 6 months period
Days of absence from day-care of the child due to infectious episodes and/or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
Time frame: 6 months period
Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
Time frame: 6 months period
Hospitalization days due to infectious disease and/or symptoms of dysbiosis
Time frame: 6 months period
Number of days (parents questionnaire and diary) of caretaker´s absenteeism from work due to infectious episodes and/or symptoms of dysbiosis of the child
Time frame: 6 months period
Number of episodes on antibiotic treatment
Time frame: 6 months period
Number of days on antibiotic treatment
Time frame: 6 months period
Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
Time frame: 6 months period
Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
Time frame: 6 months period
Quality of life reported by the parents according to standardized questionnaire
Time frame: 6 months period
Analysis of stool samples in a subset of children: microbiota changes
Time frame: 6 months period
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 12 Mar 2018.
- Background: PubMed 24903007Lohner S, Kullenberg D, Antes G, Decsi T, Meerpohl JJ. Prebiotics in healthy infants and children for prevention of acute infectious diseases: a systematic review and meta-analysis. Nutr Rev. 2014 Aug;72(8):523-31. doi: 10.1111/nure.12117. Epub 2014 Jun 5.
- 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.
Tamás Decsi, Prof. principal investigator
Department of Paediatrics, University of Pécs, Hungary
Questions about this trial
What is this clinical trial studying?
A study testing prebiotic inulin-type fructans in people with Infectious Disease and Children, Only, run by Beneo-Institute.
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 12 Mar 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?
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 febrile infectious episodes diagnosed by paediatrician (time frame: 6 months period). 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 NCT03457688, 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 12 Mar 2018.