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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| University of Helsinki | OTHER |
| The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving |
|
| 2 | Placebo Comparator | Placebo (infant cereals without any additions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus F19 | Dietary Supplement | Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eczema | Eczema including related allergic manifestations | 8 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory allergies | Allergic rhinitis and asthma | 8 years of age |
| Sensitization | Assessed by skin prick test and specific IgE tests |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina E West, MD, PhD | Clinical Sciences, Pediatrics, UmeĂĄ University, SE-901 87 UmeĂĄ, Sweden | Principal Investigator |
| Olle Hernell, Professor | Clinical Sciences, Pediatrics, UmeĂĄ University, SE-901 87 UmeĂĄ, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UmeĂĄ University | UmeĂĄ | SE-901 87 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24830782 | Background | 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. | |
| 18086218 | Result | 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. |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D006967 | Hypersensitivity |
| D001249 | Asthma |
| D009765 | Obesity |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Medical Research Council |
| OTHER_GOV |
| Ekhagastiftelsen | OTHER |
| The county of Västerbotten | UNKNOWN |
| Oskar Foundation | OTHER |
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| Placebo | Dietary Supplement | Infant cereals without any addition |
|
| 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 |
| 19298231 | 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. |
| 22417212 | 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. |
| 23895631 | 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. |
| 23838478 | 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. |
| D007154 |
| Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |