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Completed

NCT Number: NCT02180581

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

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.

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Key information

Conditions

Days Absent From Daycare Allergy Gastrointestinal Infections Hypersensitivity Immune System Diseases Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

8 month–14 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Section of Paediatric and International Nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Probiotic (2 * 10^9 cfu/day)

Dietary Supplement

Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months

Other names: bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, Lactobacillus Rhamnosus GG (LGG), 10^9 cfu/day

Placebo

Dietary Supplement

Placebo for 6 months

Primary outcomes

  1. Number of days absent from daycare due to respiratory and gastrointestinal infections

    Time frame: up to 6 month

    Recorded weekly by the parents using web-based questionnaires

Secondary outcomes

  1. Acute upper respiratory tract infections

    Time frame: Up to 6 month

    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.

  2. Acute lower respiratory infections

    Time frame: Up to 6 month

    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.

  3. Gastrointestinal infections

    Time frame: Up to 6 month

    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

  4. Fever

    Time frame: Up to 6 month

    Number of days with fever

    Recorded by the parents using web-based questionnaires

  5. Antibiotic use

    Time frame: Up to 6 month

    Number of treatments with antibiotics during the intervention period

    Recorded weekly by the parents using web-based questionnaires

  6. Allergies

    Time frame: Up to 6 month

    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

  7. Absence from day care due to illness other than infections

    Time frame: Up to 6 month

    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

  8. Parental absence from work due to illness of the child

    Time frame: Up to 6 month

    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

  9. Medical visits

    Time frame: Up to 6 month

    Number of visits to a doctor due to infections and other illnesses, respectively.

    Recorded by the parents using web-based questionnaires

  10. Change from baseline in Thymus size

    Time frame: At baseline and after 6 mo (end of intervention)

    Change in thymic size during intervention period will be evaluated using ultrasound

Other outcomes

  1. Change from baseline in biological markers for the immune system

    Time frame: At baseline and after 6 mo

    Analysis of biological material investigating the effect on the immune system by biological markers .

  2. Change from baseline in biological markers for gastro-intestinal tract

    Time frame: At baseline and after 6 mo

    Analysis of biological material investigating the effect on the gastrointestinal tract.

  3. Change from baseline in Biological markers of allergy

    Time frame: At baseline and after 6 mo

    analysis of biological samples investigating the effect on allergy by biological markers at baseline and at 6 mo

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Novonesis
  • Odense University Hospital
  • Statens Serum Institut
  • Technical University of Denmark
  • The Danish Council for Strategic Research
  • University of Bergen

Registry information

Acronym: ProbiComp

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2014
Registry last updated
Aug 24, 2016

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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