MedDataX Logo

Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics

NCT ID: NCT00200954

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Food Allergy Atopic Dermatitis Asthma Rhinitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

prospective intervention randomised probiotics atopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran

2

Probiotic bacteria group

Group Type ACTIVE_COMPARATOR

Probiotic bacteria

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UMC Utrecht

OTHER

Sponsor Role collaborator

The Netherlands Asthma Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Medical Centre Utrecht, Wilhelmina Childrens' Hospital, The Netherlands

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maarten O Hoekstra, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Wilhelmina Children's Hospital Utrecht (UMCU)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wilhelmina Children's Hospital (UMCU)

Utrecht, Utrecht, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Related Links

Access external resources that provide additional context or updates about the study.

http://www.kinderallergologie.nl

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PANDA

Identifier Type: -

Identifier Source: org_study_id