Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children

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.

Study Overview

• Status: Completed
• Conditions: Infectious Disease; Diet Modification; Children, Only
• Intervention / Treatment: Dietary supplement: prebiotic inulin-type fructans; Dietary supplement: placebo maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 850
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prebiotic inulin-type fructans	Dietary supplement: prebiotic inulin-type fructans
Placebo Comparator: placebo maltodextrin	Dietary supplement: placebo maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of febrile infectious episodes diagnosed by paediatrician	6 months period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of any infectious episodes diagnosed by paediatrician		6 months period
Number of episodes with symptoms of illnesses indicating a viral or bacterial infection		6 months period
Duration of febrile infectious episodes diagnosed by the paediatrician		6 months period
Duration of any infectious episode		6 months period
Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection		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		6 months period
Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment		6 months period
Hospitalization days due to infectious disease and/or symptoms of dysbiosis		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		6 months period
Number of episodes on antibiotic treatment		6 months period
Number of days on antibiotic treatment		6 months period
Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)		6 months period
Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)		6 months period
Quality of life reported by the parents according to standardized questionnaire	Parent Diary (scale: no, minor, moderate, significant changes, Not known)	6 months period
Analysis of stool samples in a subset of children: microbiota changes		6 months period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of gastrointestinal discomfort	Main Parameters of safety	6 months period
Body Weight	Main Parameters of safety	6 months period
Body Height	Main Parameters of safety	6 months period
Side effects (Questionnaire)	Main Parameters of safety	6 months period

Collaborators and Investigators

• Sponsor: Beneo-Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 16002n_

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No