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

Primary Purpose

Asthma, Dermatitis, Atopic, Rhinitis, Allergic, Perennial

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Probiotic
placebo
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Prevention, Probiotics, Allergy, Hypersensitivity

Eligibility Criteria

30 Weeks - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dep of Public health and general Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

probiotic

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Atopic sensitization
Positive skin prick test (SPT), elevated total IgE and elevated specific IgE
Intestinal microflora
Intestinal colonisation with LGG.
Oral cavity colonisation with LGG.
Immunomarkers
TGF in breastmilk
Cytokine profile from activated PBMC

Full Information

First Posted
September 8, 2005
Last Updated
February 4, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
Tine, St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00159523
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Tine, St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Dermatitis, Atopic, Rhinitis, Allergic, Perennial
Keywords
Prevention, Probiotics, Allergy, Hypersensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
probiotic
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Lactobacillus rhamnosus GG
Intervention Type
Biological
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Atopic sensitization
Time Frame
2 years
Title
Positive skin prick test (SPT), elevated total IgE and elevated specific IgE
Time Frame
2 years
Title
Intestinal microflora
Time Frame
2 years
Title
Intestinal colonisation with LGG.
Time Frame
2 years
Title
Oral cavity colonisation with LGG.
Time Frame
2 years
Title
Immunomarkers
Time Frame
2 years
Title
TGF in breastmilk
Time Frame
2 years
Title
Cytokine profile from activated PBMC
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Katarina Cartfjord, Director
Organizational Affiliation
Faculty of Medicine, NTNU
Official's Role
Study Director
Facility Information:
Facility Name
Dep of Public health and general Practice
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20545688
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.
Results Reference
result
PubMed Identifier
26232126
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.
Results Reference
result
PubMed Identifier
33240830
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.
Results Reference
derived
PubMed Identifier
28837002
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. Erratum In: Microbiome. 2021 May 21;9(1):120.
Results Reference
derived
PubMed Identifier
27453775
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.
Results Reference
derived
PubMed Identifier
26657066
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.
Results Reference
derived
PubMed Identifier
25782657
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.
Results Reference
derived

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

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