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Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period (ProbiComp)

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ClinicalTrials.gov Identifier: NCT02032056
Recruitment Status : Terminated (Changes in study design)
First Posted : January 9, 2014
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
The Danish Council for Strategic Research
Chr Hansen
Technical University of Denmark
University of Bergen
Odense University Hospital
Statens Serum Institut
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:
The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.

Condition or disease Intervention/treatment Phase
Days Absent From Day Care Respiratory Tract Infections Gastrointestinal Infections Allergy Dietary Supplement: Probiotic (10^9 CFU/day) Dietary Supplement: Probiotic (10^8 CFU/day) Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: probiotic (10^9 cfu/day)
Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, provided as powder in a sachet which can be added to food or drink.
Dietary Supplement: Probiotic (10^9 CFU/day)
Other Name: Bifidobacterium animalis ssp. Lactis (BB12)

Experimental: probiotic (10^8 cfu/day)
Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^8 cfu/day, provided as powder in a sachet which can be added to food or drink.
Dietary Supplement: Probiotic (10^8 CFU/day)
Other Name: Bifidobacterium animalis ssp. Lactis (BB12)

Placebo Comparator: Placebo
provided as powder in a sachet which can be added to food or drink.
Other: Placebo



Primary Outcome Measures :
  1. Number of days absent from day care due to respiratory and gastrointestinal infections [ Time Frame: Up to 6 month ]
    Recorded weekly by the parents using web-based questionnaires


Secondary Outcome Measures :
  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 questionnires


  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 monthly 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 ultraound


Other Outcome Measures:
  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



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Ages Eligible for Study:   9 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 9 - 12 1/2 month at intervention start
  • Start in daycare 4 +/- 2 weeks after intervention start
  • Single born

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

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): NCT02032056


Locations
Denmark
Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Danish Council for Strategic Research
Chr Hansen
Technical University of Denmark
University of Bergen
Odense University Hospital
Statens Serum Institut

Responsible Party: Arne Astrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02032056     History of Changes
Other Study ID Numbers: H-3-2013-064
H-3-2013-064 ( Other Grant/Funding Number: The Danish Council for Strategic Research )
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by Arne Astrup, University of Copenhagen:
Infections
Allergy
Immune function
Microbiota
infant

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hypersensitivity
Respiratory Tract Infections
Immune System Diseases
Respiratory Tract Diseases