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CompletedNCT00159523Updated Feb 5, 2016

Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic

An interventional study of Probiotic and placebo in Asthma, Dermatitis, Atopic and Rhinitis, Allergic, Perennial, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 30 Weeks to 36 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-05.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
416
Allocation
Randomized
Ages
30 Weeks to 36 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma
  • Dermatitis, Atopic
  • Rhinitis, Allergic, Perennial

Keywords

  • Prevention
  • Probiotics
  • Allergy
  • Hypersensitivity
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 416 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Weeks to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
416 participants (actual)

Study arms

  • Experimental
    probiotic

    Dietary Supplement: Probiotic

  • Placebo comparator
    placebo

    Biological: placebo

Interventions

  • Dietary supplementProbiotic

    Also known as: Lactobacillus rhamnosus GG

  • Biologicalplacebo
06

What researchers measure

Primary outcomes

  1. Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age

    Time frame: 2 years

Secondary outcomes

  1. Atopic sensitization

    Time frame: 2 years

  2. Positive skin prick test (SPT), elevated total IgE and elevated specific IgE

    Time frame: 2 years

  3. Intestinal microflora

    Time frame: 2 years

  4. Intestinal colonisation with LGG.

    Time frame: 2 years

  5. Oral cavity colonisation with LGG.

    Time frame: 2 years

  6. Immunomarkers

    Time frame: 2 years

  7. TGF in breastmilk

    Time frame: 2 years

  8. Cytokine profile from activated PBMC

    Time frame: 2 years

07

Study locations

1 site
  • Dep of Public health and general Practice
    Trondheim, 7489, Norway
08

References and documents

Publications

  • 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. PubMed 20545688 ↗
  • 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. PubMed 26232126 ↗
  • 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. PubMed 33240830 ↗
  • 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. Erratum In: Microbiome. 2021 May 21;9(1):120. doi: 10.1186/s40168-021-01094-x. PubMed 28837002 ↗
  • 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. PubMed 27453775 ↗
  • 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. PubMed 26657066 ↗
  • 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. PubMed 25782657 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00159523
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Tine, St. Olavs Hospital
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Dec 2003
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Feb 5, 2016

Study contacts

Anne Katarina Cartfjord, Director
study director · Faculty of Medicine, NTNU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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