Probiotics in Prevention of Allergies, Obesity and Caries

Study Overview
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Brief Summary
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During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age. The effects of LF19 on gut microbial composition, infections, allergies, immunological development, growth and blood lipids were monitored. Of 179 included infants, 171 completed the study. The study product was well tolerated with no observed side effects. Compliance was excellent. In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during weaning on allergies, immune programming, overweight, gut microbial composition and oral health in 8-year old children. The investigators' primary outcome will be to determine whether daily intake of LF19 during weaning results in less eczema at 8 years of age, and if the preventive effect encompasses also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects on gut microbial composition, overweight and metabolic markers will be investigated. Furthermore, the possible preventive effects of LF19 on caries will be assessed.

Official Title
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Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health

Conditions
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Eczema, Allergy, Asthma, Obesity, Dental Caries

Intervention / Treatment
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* Dietary Supplement: Lactobacillus F19
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants born at term (gestational age 37-42 weeks) Birth weight > 2500 g Vaginally delivered No atopic manifestation A normal diet for age No medication that could have affected the intestinal microbiota

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving | Dietary Supplement: Lactobacillus F19<br>* Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving<br>|
| Placebo Comparator: 2<br>Placebo (infant cereals without any additions) | Dietary Supplement: Placebo<br>* Infant cereals without any addition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema | Eczema including related allergic manifestations | 8 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory allergies | Allergic rhinitis and asthma | 8 years of age | 
| Sensitization | Assessed by skin prick test and specific IgE tests | 8 years of age | 
| Overweight/obesity | Assessed by BMI and DEXA-scan | 8 years of age | 
| Gut microbial composition | Assessed by Molecular biology techniques | 8 years of age | 
| Caries | Clinical evaluation and x-ray | 8 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Probiotics, Eczema, Allergy, Asthma, Obesity, Caries, Gut microbiota