Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-16

Study Completion Date

2014-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03457688

Infectious Disease Children, Only Diet Modification

COMPLETED NA

Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

NCT00826137

Antibiotic-Associated Diarrhea

COMPLETED PHASE3

Prebiotic EffecT InfanTs

NCT04791956

Infant Development Healthy Diet, Healthy

UNKNOWN NA

Effects of Fructan Prebiotics on the Intestinal Microbiota

NCT01277445

Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding

COMPLETED NA

Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

NCT04441359

Infection Microbial Colonization Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infectious Disease Children, Only Diet Modification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

prebiotic inulin-type fructan

Group Type ACTIVE_COMPARATOR

prebiotic inulin-type fructan

Intervention Type DIETARY_SUPPLEMENT

placebo maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prebiotic inulin-type fructan

Intervention Type DIETARY_SUPPLEMENT

Placebo maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes