Infectious DiseaseNCT03241355
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
A study testing prebiotic inulin-type fructan in people with Infectious Disease and Children, Only, run by Beneo-Institute.
Trial summary
The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period. 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 fructan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2013to 28 Apr 2014
- 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
- congenital disease or malformation influencing the gastrointestinal System
- children with congenital or acquired immunodeficiency
- children with food intolerance, food allergy or metabolic disorder requiring special diet
- children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
- children who consumed antibiotics or laxatives within 14 days
- children who had any infectious disease within 14 days at the time of pre-examination
About this study
Official title: Double-blind, Parallel, Randomized, (Placebo-controlled) Explorative Study on the Effect of a Mixture of Prebiotic Oligosaccharides on the Composition of Intestinal Microbiota and Selected Health Outcomes in Children 3 to 6 Years of Age
The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.
- Conditions
- Infectious Disease, Children, Only, Diet Modification
- Being tested
- prebiotic inulin-type fructan, 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 fructanDietary supplement
Placebo maltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| prebiotic inulin-type fructan | Active comparator | Not described Receives: Dietary Supplement: prebiotic inulin-type fructan |
| 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.
Frequency of infectious disease episodes
Measured: 24 weeks period
Secondary outcomes (1)
microbiota composition
fecal microbiota composition (qPCR, illumina)
Measured: 24 weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start16 Sep 2013
- Primary completion28 Apr 2014
- Study completion28 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 258 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
- NCT03241355
- Sponsor's protocol ID
- 13004n_Fructan_Study
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2017
- Last updated
- 28 Aug 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 24903007Lohner S, Jakobik V, Mihalyi K, Soldi S, Vasileiadis S, Theis S, Sailer M, Sieland C, Berenyi K, Boehm G, Decsi T. Inulin-Type Fructan Supplementation of 3- to 6-Year-Old Children Is Associated with Higher Fecal Bifidobacterium Concentrations and Fewer Febrile Episodes Requiring Medical Attention. J Nutr. 2018 Aug 1;148(8):1300-1308. doi: 10.1093/jn/nxy120.
PubMed 29982534Soldi S, Vasileiadis S, Lohner S, Uggeri F, Puglisi E, Molinari P, Donner E, Sieland C, Decsi T, Sailer M, Theis S. Prebiotic supplementation over a cold season and during antibiotic treatment specifically modulates the gut microbiota composition of 3-6 year-old children. Benef Microbes. 2019 Apr 19;10(3):253-263. doi: 10.3920/BM2018.0116. Epub 2019 Feb 19.
PubMed 30776899
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Parallel, Randomized, (Placebo-controlled) Explorative Study on the Effect of a Mixture of Prebiotic Oligosaccharides on the Composition of Intestinal Microbiota and Selected Health Outcomes in Children 3 to 6 Years of Age
- ClinicalTrials.gov ID
- NCT03241355
- Acronym / sponsor ID
- 13004n_Fructan_Study
- Conditions
- Infectious Disease, Children, Only, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2013 (actual)
- Primary completion
- 28 Apr 2014 (actual)
- Study completion
- 28 Apr 2014 (actual)
- First posted
- 7 Aug 2017 (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 explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.
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 fructan | Active comparator | Dietary Supplement: prebiotic inulin-type fructan |
| 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 (6 listed)
- congenital disease or malformation influencing the gastrointestinal System
- children with congenital or acquired immunodeficiency
- children with food intolerance, food allergy or metabolic disorder requiring special diet
- children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
- children who consumed antibiotics or laxatives within 14 days
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 fructan | Dietary supplement | prebiotic inulin-type fructan |
| Placebo maltodextrin | Dietary supplement | placebo maltodextrin |
Primary outcome
Frequency of infectious disease episodes
Time frame: 24 weeks period
1 secondary outcome
microbiota composition
Time frame: 24 weeks 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 28 Aug 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.
- Results publication: PubMed 29982534Lohner S, Jakobik V, Mihalyi K, Soldi S, Vasileiadis S, Theis S, Sailer M, Sieland C, Berenyi K, Boehm G, Decsi T. Inulin-Type Fructan Supplementation of 3- to 6-Year-Old Children Is Associated with Higher Fecal Bifidobacterium Concentrations and Fewer Febrile Episodes Requiring Medical Attention. J Nutr. 2018 Aug 1;148(8):1300-1308. doi: 10.1093/jn/nxy120.
- Derived from this study: PubMed 30776899Soldi S, Vasileiadis S, Lohner S, Uggeri F, Puglisi E, Molinari P, Donner E, Sieland C, Decsi T, Sailer M, Theis S. Prebiotic supplementation over a cold season and during antibiotic treatment specifically modulates the gut microbiota composition of 3-6 year-old children. Benef Microbes. 2019 Apr 19;10(3):253-263. doi: 10.3920/BM2018.0116. Epub 2019 Feb 19.
- Individual participant dataSharing planned: No
Related trials for Infectious Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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 fructan 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 6 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 28 Aug 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?
Frequency of infectious disease episodes (time frame: 24 weeks 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 NCT03241355, which also lists 3 linked publications.
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 28 Aug 2018.