Probiotics in Prevention of Allergies, Obesity and Caries (ELEFANT)

Umeå University

Status: Completed

Conditions: Dental Caries; Asthma; Obesity; Eczema; Allergy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus F19

Study type: Interventional

Funder types: Other

Identifiers

NCT00894816

ELEFANT

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 4 to 4 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

121 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving

Treatment:

Dietary Supplement: Lactobacillus F19

2

Placebo Comparator group

Description:

Placebo (infant cereals without any additions)

Treatment:

Dietary Supplement: Placebo