Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics

This study has been completed.
Sponsor:
Collaborator:
UMC Utrecht
Information provided by:
The Netherlands Asthma Foundation
ClinicalTrials.gov Identifier:
NCT00200954
First received: September 12, 2005
Last updated: August 13, 2008
Last verified: May 2007
  Purpose

Administration of probiotics to pregnant women from an atopic family and subsequently to their high-risk newborns results in prevention of the incidence or in a decrease of the severity of atopic disease during infancy.


Condition Intervention
Food Allergy
Atopic Dermatitis
Asthma
Rhinitis
Dietary Supplement: Probiotic bacteria
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics.

Resource links provided by NLM:


Further study details as provided by The Netherlands Asthma Foundation:

Primary Outcome Measures:
  • Incidence and severity of atopic disease at the age of 2 years. Incidence and prevalence of eczema [ Time Frame: Follow-up at 3 months, 12 months, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum IgE, stool composition, cytokines produced by PBMNC's [ Time Frame: Follow-up at 3 months, 12 months and 24 months ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: January 2004
Study Completion Date: August 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo group
Dietary Supplement: Placebo
The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
Active Comparator: 2
Probiotic bacteria group
Dietary Supplement: Probiotic bacteria
3 x 10e9 CFU of a mixture of probiotic bacteria, once daily to the pregnant mothers last 6 weeks of pregnancy.To their offspring during the first year of life.

Detailed Description:

Background. Atopic diseases are increasing in countries with a Western lifestyle. The hygiene hypothesis states that the increase in atopic disease could be due to reduced exposure to microbial antigens in early in life. In search of new preventive therapies for atopic disease, exposure of pregnant women with previous or recent atopic disease, and their offspring to probiotics has been suggested. Probiotics are mono or mixed cultures of microbes which, when applied to animal or man, can beneficially affect the host, among others by inducing an immune response. Probiotics are generally accepted to be safe in children. Probiotics have shown to be effective in primary prevention of atopic disease in high-risk neonates in one study so far. However, it is still unclear by what mechanism probiotics work and which is the most immunopotent (combinations of) probiotic(s). It is likely that antigen-presenting cells (APC's) are involved, since these cells are important in the first line of defence in the gastrointestinal tract. It can be imagined that the immune response is the result of the interplay between probiotics and APC's. In particular, the match between pathogen-associated molecular patterns (PAMP's) on probiotics and their counterparts on APC's, the pathogen-recognition-receptors (PRR's) (like for instance Toll-like receptors) is decisive in this aspect.

Hypothesis. Administration of probiotics to pregnant women and their offspring may reduce the development of sensitization as well as the onset of atopic disease in their offspring.

Aim. To study the effect of probiotics on sensitisation and the prevalence of atopic disease, the severity of atopic disease, the intestinal flora and immune parameters in high-risk newborns.

Methods. To study this hypothesis, a randomised, double-blind placebo-controlled trial will be carried out by administration of probiotics to pregnant women with previous or recent atopic disease as well as to their offspring. Primary outcome parameters are firstly the prevalence and severity of sensitization and atopic disease in the offspring during a follow-up of two years. Secondary outcome parameters are the change in stool composition during treatment with probiotics and in-vitro production of cytokines by PBMCs collected at 3 months, 1 year and 2 years of age.

Expected results. Perinatal administration of probiotics to pregnant women and their offspring may hamper the development of sensitization and atopic disease in their offspring. This may be due to modulation of the intestinal microbiota composition, and modulation of the developing immune system

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant mothers were included if either they themselves or their husband plus one sibling suffered from present or past atopic disease

Exclusion Criteria:

  • Maternal use of immunomodulatory drugs during pregnancy, the use of probiotics prior to the start of the study.
  • Children were excluded from the study if their mother received antibiotic treatment during the last two weeks of pregnancy
  • When the child was born preterm, i.e. before 37 weeks of gestation
  • If the children received antibiotic treatment in the first two weeks of life
  • If ingestion of the study product was difficult due to vomiting or feeding problems in general for longer than 3 weeks from birth
  • If the children had other major medical problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200954

Locations
Netherlands
Wilhelmina Children's Hospital (UMCU)
Utrecht, Netherlands, 3508AB
Sponsors and Collaborators
The Netherlands Asthma Foundation
UMC Utrecht
Investigators
Principal Investigator: Maarten O Hoekstra, MD PhD Wilhelmina Children's Hospital Utrecht (UMCU)
  More Information

Additional Information:
No publications provided

Responsible Party: M.O. Hoekstra, M.D., PhD., University Medical Centre Utrecht, Wilhelmina Childrens' Hospital, The Netherlands
ClinicalTrials.gov Identifier: NCT00200954     History of Changes
Other Study ID Numbers: PANDA
Study First Received: September 12, 2005
Last Updated: August 13, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Asthma Foundation:
prospective
intervention
randomised
probiotics
atopy

Additional relevant MeSH terms:
Asthma
Dermatitis
Dermatitis, Atopic
Food Hypersensitivity
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014