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| Name | Class |
|---|---|
| Tine | INDUSTRY |
| St. Olavs Hospital | OTHER |
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A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo.
To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establishment and composition of the gut microflora in children from birth until two years of age.
At the same time to investigate the relationship between gut flora composition and the development of the immune system.
To investigate the relationship between supplement of probiotics to pregnant and breast-feeding women, the microbial composition of the gut flora in their children, the development of the childrens' immune system, and the prevalence of atopic sensitisation and atopic disease at two years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Atopic sensitization | 2 years | |
| Positive skin prick test (SPT), elevated total IgE and elevated specific IgE | 2 years | |
| Intestinal microflora |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Katarina Cartfjord, Director | Faculty of Medicine, NTNU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep of Public health and general Practice | Trondheim | 7489 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20545688 | Result | Dotterud CK, Storro O, Johnsen R, Oien T. Probiotics in pregnant women to prevent allergic disease: a randomized, double-blind trial. Br J Dermatol. 2010 Sep;163(3):616-23. doi: 10.1111/j.1365-2133.2010.09889.x. Epub 2010 Jun 9. | |
| 26232126 | Result | Simpson MR, Dotterud CK, Storro O, Johnsen R, Oien T. Perinatal probiotic supplementation in the prevention of allergy related disease: 6 year follow up of a randomised controlled trial. BMC Dermatol. 2015 Aug 1;15:13. doi: 10.1186/s12895-015-0030-1. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D003876 | Dermatitis, Atopic |
| D012221 | Rhinitis, Allergic, Perennial |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Biological |
|
| 2 years |
| Intestinal colonisation with LGG. | 2 years |
| Oral cavity colonisation with LGG. | 2 years |
| Immunomarkers | 2 years |
| TGF in breastmilk | 2 years |
| Cytokine profile from activated PBMC | 2 years |
| 37516841 | Derived | Zakiudin DP, Ro ADB, Videm V, Oien T, Simpson MR. Systemic inflammatory proteins in offspring following maternal probiotic supplementation for atopic dermatitis prevention. Clin Mol Allergy. 2023 Jul 29;21(1):5. doi: 10.1186/s12948-023-00186-3. |
| 33240830 | Derived | Schei K, Simpson MR, Avershina E, Rudi K, Oien T, Juliusson PB, Underhill D, Salamati S, Odegard RA. Early Gut Fungal and Bacterial Microbiota and Childhood Growth. Front Pediatr. 2020 Nov 9;8:572538. doi: 10.3389/fped.2020.572538. eCollection 2020. |
| 28837002 | Derived | Schei K, Avershina E, Oien T, Rudi K, Follestad T, Salamati S, Odegard RA. Early gut mycobiota and mother-offspring transfer. Microbiome. 2017 Aug 24;5(1):107. doi: 10.1186/s40168-017-0319-x. |
| 27453775 | Derived | Simpson MR, Ro AD, Grimstad O, Johnsen R, Storro O, Oien T. Atopic dermatitis prevention in children following maternal probiotic supplementation does not appear to be mediated by breast milk TSLP or TGF-beta. Clin Transl Allergy. 2016 Jul 22;6:27. doi: 10.1186/s13601-016-0119-6. eCollection 2016. |
| 26657066 | Derived | Simpson MR, Brede G, Johansen J, Johnsen R, Storro O, Saetrom P, Oien T. Human Breast Milk miRNA, Maternal Probiotic Supplementation and Atopic Dermatitis in Offspring. PLoS One. 2015 Dec 14;10(12):e0143496. doi: 10.1371/journal.pone.0143496. eCollection 2015. |
| 25782657 | Derived | Dotterud CK, Avershina E, Sekelja M, Simpson MR, Rudi K, Storro O, Johnsen R, Oien T. Does Maternal Perinatal Probiotic Supplementation Alter the Intestinal Microbiota of Mother and Child? J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):200-7. doi: 10.1097/MPG.0000000000000781. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D019602 |
| Food and Beverages |