Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
NCT ID: NCT00159523
Last Updated: 2016-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
416 participants
INTERVENTIONAL
2003-12-31
2007-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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probiotic
Probiotic
placebo
placebo
Interventions
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Probiotic
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inclusion must take place before week 36 in the pregnancy.
* The woman must plan to breast-feed the first 4 months after birth.
* She must live in Trondheim.
Exclusion Criteria
* Lactose intolerance
* Consumption of probiotics earlier in the pregnancy.
* Intention to move from Trondheim in the next 25 months.
* Pregnant women in risk of eclampsia, or other serious disease that can influence beast-feeding or care for the child.
30 Weeks
36 Weeks
ALL
Yes
Sponsors
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Tine
INDUSTRY
St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Anne Katarina Cartfjord, Director
Role: STUDY_DIRECTOR
Faculty of Medicine, NTNU
Locations
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Dep of Public health and general Practice
Trondheim, , Norway
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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097-03
Identifier Type: -
Identifier Source: org_study_id
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