Clinical trial NCT00159523: Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Dermatitis, Atopic
Rhinitis, Allergic, Perennial
Keywords: Prevention
Probiotics
Allergy
Hypersensitivity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Tine
name: St. Olavs Hospital
First posted: 2005-09-12
Enrollment: 416
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All pregnant women understanding Norwegian language and who has signed an informed consent form, can be included.
* 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:

* 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.

Primary outcomes:
measure: Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
timeFrame: 2 years
Secondary outcomes:
measure: Atopic sensitization
timeFrame: 2 years
measure: Positive skin prick test (SPT), elevated total IgE and elevated specific IgE
timeFrame: 2 years
measure: Intestinal microflora
timeFrame: 2 years
measure: Intestinal colonisation with LGG.
timeFrame: 2 years
measure: Oral cavity colonisation with LGG.
timeFrame: 2 years
measure: Immunomarkers
timeFrame: 2 years
measure: TGF in breastmilk
timeFrame: 2 years
measure: Cytokine profile from activated PBMC
timeFrame: 2 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dep of Public health and general Practice
Study officials:
affiliation: Faculty of Medicine, NTNU
name: Anne Katarina Cartfjord, Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.