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Completed

NCT Number: NCT03457688

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

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.

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Key information

Conditions

Infectious Disease Children, Only Communicable Diseases Diet Modification Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prebiotic inulin-type fructans

Dietary Supplement

Placebo Maltodextrin

Dietary Supplement

Primary outcomes

  1. Number of febrile infectious episodes diagnosed by paediatrician

    Time frame: 6 months period

Secondary outcomes

  1. Number of any infectious episodes diagnosed by paediatrician

    Time frame: 6 months period

  2. Number of episodes with symptoms of illnesses indicating a viral or bacterial infection

    Time frame: 6 months period

  3. Duration of febrile infectious episodes diagnosed by the paediatrician

    Time frame: 6 months period

  4. Duration of any infectious episode

    Time frame: 6 months period

  5. Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection

    Time frame: 6 months period

  6. 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

  7. Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment

    Time frame: 6 months period

  8. Hospitalization days due to infectious disease and/or symptoms of dysbiosis

    Time frame: 6 months period

  9. 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

  10. Number of episodes on antibiotic treatment

    Time frame: 6 months period

  11. Number of days on antibiotic treatment

    Time frame: 6 months period

  12. Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)

    Time frame: 6 months period

  13. Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)

    Time frame: 6 months period

  14. Quality of life reported by the parents according to standardized questionnaire

    Time frame: 6 months period

    Parent Diary (scale: no, minor, moderate, significant changes, Not known)

  15. Analysis of stool samples in a subset of children: microbiota changes

    Time frame: 6 months period

Other outcomes

  1. Incidence of gastrointestinal discomfort

    Time frame: 6 months period

    Main Parameters of safety

  2. Body Weight

    Time frame: 6 months period

    Main Parameters of safety

  3. Body Height

    Time frame: 6 months period

    Main Parameters of safety

  4. Side effects (Questionnaire)

    Time frame: 6 months period

    Main Parameters of safety

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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