Food AllergyNCT00200954
Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
A study testing Probiotic bacteria in people with Food Allergy and Atopic Dermatitis, run by The Netherlands Asthma Foundation at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Food Allergy, Atopic Dermatitis, Asthma
- What is being tested?
- Probiotic bacteria
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2004to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant mothers were included if either they themselves or their husband plus one sibling suffered from present or past atopic disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wilhelmina Children's Hospital (UMCU)
Utrecht, Utrecht, 3508AB
About this study
Official title: Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics.
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.
Read the 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
- Conditions
- Food Allergy, Atopic Dermatitis, Asthma, Rhinitis
- Being tested
- Probiotic bacteria, Placebo
- Keywords
- prospective, intervention, randomised, probiotics, atopy
- Medical subject headings
- Food Hypersensitivity, Dermatitis, Atopic, Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic bacteriaDietary 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.
PlaceboDietary supplement
The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo group Receives: Dietary Supplement: Placebo |
| 2 | Active comparator | Probiotic bacteria group Receives: Dietary Supplement: Probiotic bacteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of atopic disease at the age of 2 years. Incidence and prevalence of eczema
Measured: Follow-up at 3 months, 12 months, and 24 months
Secondary outcomes (1)
Serum IgE, stool composition, cytokines produced by PBMNC's
Measured: Follow-up at 3 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Asthma Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Investigators
- Maarten O Hoekstra, MD PhD, Principal investigator, Wilhelmina Children's Hospital Utrecht (UMCU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200954
- Sponsor's protocol ID
- PANDA
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 18 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics.
- ClinicalTrials.gov ID
- NCT00200954
- Acronym / sponsor ID
- PANDA
- Conditions
- Food Allergy, Atopic Dermatitis, Asthma, Rhinitis
- Keywords
- prospective, intervention, randomised, probiotics, atopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- The Netherlands Asthma FoundationUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placeboplacebo group |
| 2 | Active comparator | Dietary Supplement: Probiotic bacteriaProbiotic bacteria group |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant mothers were included if either they themselves or their husband plus one sibling suffered from present or past atopic disease
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic bacteria3 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. | Dietary supplement | 2 |
| PlaceboThe placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran | Dietary supplement | placebo |
Primary outcome
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
1 secondary outcome
Serum IgE, stool composition, cytokines produced by PBMNC's
Time frame: Follow-up at 3 months, 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
- click for more information: PANDA-onderzoekLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten O Hoekstra, MD PhD principal investigator
Wilhelmina Children's Hospital Utrecht (UMCU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic bacteria in people with Food Allergy and Atopic Dermatitis, run by The Netherlands Asthma Foundation at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2008.