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

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ClinicalTrials.gov Identifier: NCT03457688
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Beneo-Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infectious Disease Children, Only Diet Modification Dietary Supplement: prebiotic inulin-type fructans Dietary Supplement: placebo maltodextrin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : September 19, 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Inulin

Arm Intervention/treatment
Active Comparator: prebiotic inulin-type fructans Dietary Supplement: prebiotic inulin-type fructans
Placebo Comparator: placebo maltodextrin Dietary Supplement: placebo maltodextrin



Primary Outcome Measures :
  1. Number of febrile infectious episodes diagnosed by paediatrician [ Time Frame: 6 months period ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457688


Sponsors and Collaborators
Beneo-Institute
Investigators
Principal Investigator: Tamás Decsi, Prof. Department of Paediatrics, University of Pécs, Hungary

Publications:
Responsible Party: Beneo-Institute
ClinicalTrials.gov Identifier: NCT03457688     History of Changes
Other Study ID Numbers: 16002n_
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Communicable Diseases
Infection
Levan
Antineoplastic Agents