Atopic DermatitisPhase 3NCT00325273
Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
A Phase 3 study testing Lactobacillus rhamnosus GG in people with Atopic Dermatitis and Allergic Rhinitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether childhood atopic disease decrease or not after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester, followed by infant intake for 6 months after birth. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Atopic Dermatitis, Allergic Rhinitis, Asthma
- What is being tested?
- Lactobacillus rhamnosus GG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2005to Apr 2010
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE > 100 kU/l and positive specific IgE
Who cannot join
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Niao-Sung, 833
About this study
Official title: Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
The purpose of this study is to determine whether childhood atopic disease decrease or not after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester, followed by infant intake for 6 months after birth.
Read the detailed description
The prevalence of atopy at Taiwan increased 8 times in past 20 years and also increased all over the world. In our previous study, maternal atopic history rather than paternal one is the major factor to effect infant eczema and IgE titers. This may be related to maternal inheritance and environments during pregnancy. Kalliomaki et al. (Lancet, vol.357, p1076-9, 2001) presented that Lactobacillus GG used 2-4 weeks prenatally to mothers and 6 months postnatally to infants was effective in prevention of early atopic disease in children at high risk.
We designed a double-blind randomized placebo-controlled study to evaluate whether cord blood IgE and childhood atopic disease decreased after allowing allergic mothers intake of Lactobacillus GG in second trimester, followed by infant intake of Lactobacillus GG for 6 months after birth.
Materials and Methods:
- Inclusion criteria: Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE > 100 kU/l and positive specific IgE.
- Case number: 100 cases were collected in both control and study groups.
- Study design: In a double blind randomized placebo-controlled study, eligible cases are allowed to take Lactobacillus GG or placebo daily from gestational age of 24 weeks until delivery in both groups. In study group, Lactobacillus GG is given prenatally from gestational age of 24 weeks to delivery for mothers and 6 months postnatally for infants. In control group, placebo starch is given prenatally from gestational age of 24 weeks for mothers to delivery and 6 months postnatally for infants.
- Schedule of follow-up: Infant/child clinical symptoms and sign are evaluated and IgE and specific IgE are tested in bloods from umbilical cords, infants in 1, 3 and 5 year old.
- Conditions
- Atopic Dermatitis, Allergic Rhinitis, Asthma
- Being tested
- Lactobacillus rhamnosus GG
- Keywords
- Lactobacillus rhamnosus, Atopic dermatitis, Allergic rhinitis, Asthma, Infant, Pregnancy
- Medical subject headings
- Dermatitis, Atopic, Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GGDietary supplement
Also called Brand names: Culturelle DS, Culturelle HS
use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months
| Study group | Role | What they receive |
|---|---|---|
| probiotics & allergy | Experimental | 1. To understand the preventive effect of probiotics in neonatal peroid
2. To investate the possible mechanism Receives: Dietary Supplement: Lactobacillus rhamnosus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of atopic disease in infant
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startApr 2005
- Primary completionApr 2008
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chia-yu Ou, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325273
- Sponsor's protocol ID
- CMRPG84025
- Status last verified
- Jun 2011
- First submitted
- 11 May 2006
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
PubMed 11297958Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71. doi: 10.1016/S0140-6736(03)13490-3.
PubMed 12788576Ou CY, Kuo HC, Wang L, Hsu TY, Chuang H, Liu CA, Chang JC, Yu HR, Yang KD. Prenatal and postnatal probiotics reduces maternal but not childhood allergic diseases: a randomized, double-blind, placebo-controlled trial. Clin Exp Allergy. 2012 Sep;42(9):1386-96. doi: 10.1111/j.1365-2222.2012.04037.x.
PubMed 22925325
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
- ClinicalTrials.gov ID
- NCT00325273
- Acronym / sponsor ID
- CMRPG84025
- Conditions
- Atopic Dermatitis, Allergic Rhinitis, Asthma
- Keywords
- Lactobacillus rhamnosus, Atopic dermatitis, Allergic rhinitis, Asthma, Infant, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 May 2006 (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.
The purpose of this study is to determine whether childhood atopic disease decrease or not after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester, followed by infant intake for 6 months after birth.
Detailed description
The prevalence of atopy at Taiwan increased 8 times in past 20 years and also increased all over the world. In our previous study, maternal atopic history rather than paternal one is the major factor to effect infant eczema and IgE titers. This may be related to maternal inheritance and environments during pregnancy. Kalliomaki et al. (Lancet, vol.357, p1076-9, 2001) presented that Lactobacillus GG used 2-4 weeks prenatally to mothers and 6 months postnatally to infants was effective in prevention of early atopic disease in children at high risk.
We designed a double-blind randomized placebo-controlled study to evaluate whether cord blood IgE and childhood atopic disease decreased after allowing allergic mothers intake of Lactobacillus GG in second trimester, followed by infant intake of Lactobacillus GG for 6 months after birth.
Materials and Methods:
- Inclusion criteria: Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE > 100 kU/l and positive specific IgE.
- Case number: 100 cases were collected in both control and study groups.
- Study design: In a double blind randomized placebo-controlled study, eligible cases are allowed to take Lactobacillus GG or placebo daily from gestational age of 24 weeks until delivery in both groups. In study group, Lactobacillus GG is given prenatally from gestational age of 24 weeks to delivery for mothers and 6 months postnatally for infants. In control group, placebo starch is given prenatally from gestational age of 24 weeks for mothers to delivery and 6 months postnatally for infants.
- Schedule of follow-up: Infant/child clinical symptoms and sign are evaluated and IgE and specific IgE are tested in bloods from umbilical cords, infants in 1, 3 and 5 year old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| probiotics & allergy | Experimental | Dietary Supplement: Lactobacillus rhamnosus GG1. To understand the preventive effect of probiotics in neonatal peroid 2. To investate the possible mechanism |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE > 100 kU/l and positive specific IgE
Key exclusion criteria (1 listed)
- Multiple pregnancy
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 |
|---|---|---|
| Lactobacillus rhamnosus GGAlso: Brand names: Culturelle DS, Culturelle HSuse Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months | Dietary supplement | probiotics & allergy |
Primary outcome
Prevalence of atopic disease in infant
Time frame: two years
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 17 Mar 2015.
- Background: PubMed 11297958Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
- Background: PubMed 12788576Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71. doi: 10.1016/S0140-6736(03)13490-3.
- Derived from this study: PubMed 22925325Ou CY, Kuo HC, Wang L, Hsu TY, Chuang H, Liu CA, Chang JC, Yu HR, Yang KD. Prenatal and postnatal probiotics reduces maternal but not childhood allergic diseases: a randomized, double-blind, placebo-controlled trial. Clin Exp Allergy. 2012 Sep;42(9):1386-96. doi: 10.1111/j.1365-2222.2012.04037.x.
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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.
Chia-yu Ou, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus rhamnosus GG in people with Atopic Dermatitis and Allergic Rhinitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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 17 Mar 2015. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevalence of atopic disease in infant (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325273, which also lists 3 linked publications.
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 17 Mar 2015.