Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
The Impact of Perinatal Daily Supplement of a Probiotic (Lactobacillus Rhamnosus GG), Given to Mothers, on Immunological Development, Atopic Sensitisation and Allergic Disease in Their Off-spring
1 other identifier
interventional
416
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Dec 2003
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFebruary 5, 2016
August 1, 2015
3.8 years
September 8, 2005
February 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
2 years
Secondary Outcomes (8)
Atopic sensitization
2 years
Positive skin prick test (SPT), elevated total IgE and elevated specific IgE
2 years
Intestinal microflora
2 years
Intestinal colonisation with LGG.
2 years
Oral cavity colonisation with LGG.
2 years
- +3 more secondary outcomes
Study Arms (2)
probiotic
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- All pregnant women understanding Norwegian language and who has signed an informed consent form, can be included.
- The woman must plan to breast-feed the first 4 months after birth.
- She must live in Trondheim.
You may not qualify if:
- Not being able to fill in the questionnaire in Norwegian language
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- Tinecollaborator
- St. Olavs Hospitalcollaborator
Study Sites (1)
Dep of Public health and general Practice
Trondheim, 7489, Norway
Related Publications (8)
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.
PMID: 20545688RESULTSimpson 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.
PMID: 26232126RESULTZakiudin 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.
PMID: 37516841DERIVEDSchei 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.
PMID: 33240830DERIVEDSchei 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.
PMID: 28837002DERIVEDSimpson 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.
PMID: 27453775DERIVEDSimpson 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.
PMID: 26657066DERIVEDDotterud 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.
PMID: 25782657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne Katarina Cartfjord, Director
Faculty of Medicine, NTNU
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
December 1, 2003
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
February 5, 2016
Record last verified: 2015-08