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

Diet Modification Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457688
• Other study ID #: 16002n_
• Status: Completed
• Phase: N/A
• First received: February 21, 2018
• Last updated: March 8, 2018
• Start date: September 19, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: March 2018
• Source: Beneo-Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Communicable Diseases
• Diet Modification
• Infection
• Infectious Disease

Intervention

Dietary Supplement:
• prebiotic inulin-type fructans

• placebo maltodextrin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beneo-Institute

References & Publications (1)

Lohner S, Küllenberg 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of gastrointestinal discomfort	Main Parameters of safety	6 months period
Other	Body Weight	Main Parameters of safety	6 months period
Other	Body Height	Main Parameters of safety	6 months period
Other	Side effects (Questionnaire)	Main Parameters of safety	6 months period
Primary	Number of febrile infectious episodes diagnosed by paediatrician		6 months period
Secondary	Number of any infectious episodes diagnosed by paediatrician		6 months period
Secondary	Number of episodes with symptoms of illnesses indicating a viral or bacterial infection		6 months period
Secondary	Duration of febrile infectious episodes diagnosed by the paediatrician		6 months period
Secondary	Duration of any infectious episode		6 months period
Secondary	Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection		6 months period
Secondary	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
Secondary	Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment		6 months period
Secondary	Hospitalization days due to infectious disease and/or symptoms of dysbiosis		6 months period
Secondary	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
Secondary	Number of episodes on antibiotic treatment		6 months period
Secondary	Number of days on antibiotic treatment		6 months period
Secondary	Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)		6 months period
Secondary	Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)		6 months period
Secondary	Quality of life reported by the parents according to standardized questionnaire	Parent Diary (scale: no, minor, moderate, significant changes, Not known)	6 months period
Secondary	Analysis of stool samples in a subset of children: microbiota changes		6 months period