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

N

Norwegian University of Science and Technology

Status

Completed

Conditions

Dermatitis, Atopic
Asthma
Rhinitis, Allergic, Perennial

Treatments

Biological: placebo
Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

416 patients

Sex

All

Ages

30 to 36 weeks old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

416 participants in 2 patient groups, including a placebo group

probiotic
Experimental group
Treatment:
Dietary Supplement: Probiotic
placebo
Placebo Comparator group
Treatment:
Biological: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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