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

Beneo

Status: Completed

Conditions: Children, Only; Infectious Disease; Diet Modification

Treatments: Dietary Supplement: placebo maltodextrin; Dietary Supplement: prebiotic inulin-type fructans

Study type: Interventional

Funder types: Industry

Identifiers

NCT03457688

16002n_

Details and patient eligibility

About

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.

Enrollment: 850 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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850 participants in 2 patient groups, including a placebo group

prebiotic inulin-type fructans

Active Comparator group

Treatment:

Dietary Supplement: prebiotic inulin-type fructans

placebo maltodextrin

Placebo Comparator group

Treatment:

Dietary Supplement: placebo maltodextrin