Probiotics in Prevention of Allergies, Obesity and Caries

NCT00894816 | Completed

• 1 other identifier: ELEFANT
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eczema; Allergy; Asthma; Obesity; Dental Caries

Keywords

Prevention; Probiotics; Eczema; Allergy; Asthma; Obesity; Caries; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Eczema

  Eczema including related allergic manifestations

  8 years of age

Secondary Outcomes (5)

• Respiratory allergies

  8 years of age

• Sensitization

  8 years of age

• Overweight/obesity

  8 years of age

• Gut microbial composition

  8 years of age

• Caries

  8 years of age

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: Lactobacillus F19

2

PLACEBO COMPARATOR

Placebo (infant cereals without any additions)

Dietary Supplement: Placebo

Interventions

Lactobacillus F19 DIETARY_SUPPLEMENT

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

1

Placebo DIETARY_SUPPLEMENT

Infant cereals without any addition

2

Eligibility Criteria

• Age: 4 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Karolinska Institutet: collaborator
• University of Helsinki: collaborator
• The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS): collaborator
• Medical Research Council: collaborator
• Ekhagastiftelsen: collaborator
• The county of Västerbotten: collaborator
• Oskar Foundation: collaborator

Study Sites (1)

Umeå University

Umeå, SE-901 87, Sweden

Location

Related Publications (6)

• Karlsson Videhult F, Ohlund I, Stenlund H, Hernell O, West CE. Probiotics during weaning: a follow-up study on effects on body composition and metabolic markers at school age. Eur J Nutr. 2015 Apr;54(3):355-63. doi: 10.1007/s00394-014-0715-y. Epub 2014 May 17.

  PMID: 24830782 BACKGROUND

• West CE, Gothefors L, Granstrom M, Kayhty H, Hammarstrom ML, Hernell O. Effects of feeding probiotics during weaning on infections and antibody responses to diphtheria, tetanus and Hib vaccines. Pediatr Allergy Immunol. 2008 Feb;19(1):53-60. doi: 10.1111/j.1399-3038.2007.00583.x. Epub 2007 Dec 11.

  PMID: 18086218 RESULT

• West CE, Hammarstrom ML, Hernell O. Probiotics during weaning reduce the incidence of eczema. Pediatr Allergy Immunol. 2009 Aug;20(5):430-7. doi: 10.1111/j.1399-3038.2009.00745.x. Epub 2009 Mar 9.

  PMID: 19298231 RESULT

• West CE, Hernell O, Andersson Y, Sjostedt M, Hammarstrom ML. Probiotic effects on T-cell maturation in infants during weaning. Clin Exp Allergy. 2012 Apr;42(4):540-9. doi: 10.1111/j.1365-2222.2011.03941.x.

  PMID: 22417212 RESULT

• West CE, Hammarstrom ML, Hernell O. Probiotics in primary prevention of allergic disease--follow-up at 8-9 years of age. Allergy. 2013 Aug;68(8):1015-20. doi: 10.1111/all.12191. Epub 2013 Jul 30.

  PMID: 23895631 RESULT

• Hasslof P, West CE, Videhult FK, Brandelius C, Stecksen-Blicks C. Early intervention with probiotic Lactobacillus paracasei F19 has no long-term effect on caries experience. Caries Res. 2013;47(6):559-65. doi: 10.1159/000350524. Epub 2013 Jul 4.

  PMID: 23838478 RESULT

MeSH Terms

Conditions

Eczema; Hypersensitivity; Asthma; Obesity; Dental Caries

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Christina E West, MD, PhD

  Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden

  PRINCIPAL INVESTIGATOR

• Olle Hernell, Professor

  Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: August 1, 2000
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

SE (1)