Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare

Allergy Clinical Trial

— ProbiComp  

Official title:

Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180581
• Other study ID #: H-4-2014-032
• Secondary ID: H-4-2014-032
• Status: Completed
• Phase: N/A
• First received: June 30, 2014
• Last updated: August 23, 2016
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The aim of the intervention is to examine the effect of a combination of the two bacterial strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic manifestations in small children, and how a combination of BB-12 and LGG affects the immune system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Months to 14 Months

Eligibility

Inclusion Criteria:

• Expected to start daycare between the age of 8-14 month

• Intervention start 0 days to 12 weeks before starting daycare

• Expected to start daycare from september to february (both month included)

• Single born

Exclusion Criteria:

• Exclusion Criteria:

• Children born before 37th gestational week

• Children with a birth weight < 2500 g

• Children suffering from severe chronic illness

• Children receiving regular medication

• Children who have received antibiotics within a month before intervention start

• Children whose parents do not speak Danish

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergy
• Communicable Diseases
• Days Absent From Daycare
• Gastrointestinal Infections
• Hypersensitivity
• Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Probiotic (2 * 10^9 cfu/day)
Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months
• Placebo
Placebo for 6 months

Locations

Country	Name	City	State
Denmark	Section of Paediatric and International Nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen	Frederiksberg

Sponsors (7)

Lead Sponsor	Collaborator
University of Copenhagen	Chr Hansen A/S, Odense University Hospital, Statens Serum Institut, Technical University of Denmark, The Danish Council for Strategic Research, University of Bergen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in biological markers for the immune system	Analysis of biological material investigating the effect on the immune system by biological markers .	At baseline and after 6 mo	No
Other	Change from baseline in biological markers for gastro-intestinal tract	Analysis of biological material investigating the effect on the gastrointestinal tract.	At baseline and after 6 mo	No
Other	Change from baseline in Biological markers of allergy	analysis of biological samples investigating the effect on allergy by biological markers at baseline and at 6 mo	At baseline and after 6 mo	No
Primary	Number of days absent from daycare due to respiratory and gastrointestinal infections	Recorded weekly by the parents using web-based questionnaires	up to 6 month	No
Secondary	Acute upper respiratory tract infections	Number of days with acute upper respiratory tract infections (URTI); Number of children with at least 1 episode of URTI; Number of children with at least 3 episodes of URTI; Number of URTI episodes/child/year; Duration of URTI episodes (days); Additionally,symptoms of cold (defined as 2 days with runny/stuffy nose or cough); Recorded by the parents daily/weekly using web-based questionnaires.	Up to 6 month	No
Secondary	Acute lower respiratory infections	Number of children with at least 1 episode of a lower respiratory tract infection (LRTI).; LRTI include bronchitis and pneumonia; Recorded by the parents weekly using web-based questionnaires.	Up to 6 month	No
Secondary	Gastrointestinal infections	Number of children with at least 1 episode of diarrhea; Duration of episodes with diarrhea(days); Number of episodes/child/year with diarrhea; Number of days with vomiting.; Recorded by the parents daily using web-based questionnaires	Up to 6 month	No
Secondary	Fever	Number of days with fever; Recorded by the parents using web-based questionnaires	Up to 6 month	No
Secondary	Antibiotic use	Number of treatments with antibiotics during the intervention period; Recorded weekly by the parents using web-based questionnaires	Up to 6 month	No
Secondary	Allergies	Number of children developing allergies during the intervention period (asthma, allergic rhinitis, atopic dermatitis, food allergies); Age for diagnosis of allergies; Use of medication due to allergies.; Recorded by the parents using web-based questionnaires	Up to 6 month	No
Secondary	Absence from day care due to illness other than infections	Number of days the child is absent from day care due to illness, which is not due to infections.; Recorded by the parents weekly using web-based questionnaires	Up to 6 month	No
Secondary	Parental absence from work due to illness of the child	Number of days a parent is absent from work due to illness of the child (infections and other illnesses, respectively); Recorded by the parents weekly using web-based questionnaires	Up to 6 month	No
Secondary	Medical visits	Number of visits to a doctor due to infections and other illnesses, respectively.; Recorded by the parents using web-based questionnaires	Up to 6 month	No
Secondary	Change from baseline in Thymus size	Change in thymic size during intervention period will be evaluated using ultrasound	At baseline and after 6 mo (end of intervention)	No