Allergic DiseasesNCT03873792
Oral Probiotics to Allergic Pregnant Mother and Their Offspring to Prevent Allergic Disease
A study testing Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women in people with Allergic Diseases, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The aim of the study is first to detect the difference of the intestinal microbiome between allergic pregnant mother and the non-allergic pregnant mother using the next generation sequence, all postnatal infants will collect the first meconium and feces from one, two, six months to one year old for the same test. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Allergic Diseases
- What is being tested?
- Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 31 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- An adult pregnant mother who is over 20 years old and has a history of asthma or eczema or allergic rhinitis who is exercising autonomous consent.
- Pregnant women over 20 years old without allergies.
- Infants ≧ 37 weeks gestational age.
Who cannot join
- Under 20 years old.
- Pregnant mothers and babies with congenital immune diseases.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Pediatrics, Children Hospital, China Medical University
Taichung, 404
About this study
The aim of the study is first to detect the difference of the intestinal microbiome between allergic pregnant mother and the non-allergic pregnant mother using the next generation sequence, all postnatal infants will collect the first meconium and feces from one, two, six months to one year old for the same test. The second stage of the study is to restore the allergic pregnant mother abnormal intestinal microbiome with probiotics trying to reduce the incidence of allergic disease of their offspring.
Read the detailed description
Allergic diseases are the largest group of non-communicable diseases (NCD) with an increasing prevalence in both the developed and developing world. There are significant bodies of research trying to examine the use of probiotics to prevent allergic disease. Though clinical randomized controlled trials and meta-analyses shows benefits of using probiotic supplements during pregnancy and early infant life to prevent the development of atopic dermatitis ; however, Cochrane review found that the benefit is not significant for immunoglobulin E (IgE) associated atopy. The lack of effectiveness that probiotics supplement to prevent allergic offspring to the allergic pregnant mother might due to too late to give probiotics and not give the appropriate probiotics. Investigators speculate that intestinal microbiota of allergic pregnant mother is different from the non-allergic pregnant mother. According to the theory that intestinal microbiome of pregnant mother might affect the offprint's intestinal microbiota during labor and further induce the allergic status.
The aim of the study is first to detect the difference of the intestinal microbiome between allergic pregnant mother and the non-allergic pregnant mother using the next generation sequence, all postnatal infants will collect the first meconium and feces from one, two, six months to one year old for the same test. The second stage of the study is to restore the allergic pregnant mother abnormal intestinal microbiome with probiotics trying to reduce the incidence of allergic disease of their offspring.
Allergic pregnant women who intend to breast- feed their infant are eligible to be enrolled in the study if she has a history of asthma or eczema treated or allergic rhinitis treated by a doctor. All infants born in the study are eligible for inclusion in study outcomes. Study probiotics containing Lactobacillus and Bifidobacterium, and the placebo capsules are made from glucose, both are manufactured by Taiwan Company. After inform consent, probiotics will give to the allergic pregnant women till delivery and infants will have probiotics for 6 months after born. Primary outcome is the prevalence of physician diagnosis atopic eczema and frequency of wheezing attack at 24 month of age.
Randomization is managed by computer at pharmacy of CMUH and concealed from all study staff and participants. An intention-to-treat analysis will be used to assess the effect of probiotics on the 24 month cumulative prevalence of eczema and SCORAD ≥10 using hazard ratios from a Cox's proportional hazards model, and the point prevalence of atopy at age 24 months using relative rates and a chi- squared test. Chi-square test will also be used to compare the proportion in each study group with detectable levels of immunological markers in breast milk. If the data is not log-normally distributed a Wilcoxon Rank-Sum test will be used. Reasons for withdrawal from the study will be recorded and examined for differences between study groups. Adjustment will be made for differences in antibiotic use between study groups. SAS version 9.4 will be used.
- Conditions
- Allergic Diseases
- Being tested
- Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women
- Keywords
- Allergic diseases, Probiotics, Immunoglobulin E, Intestinal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant womenDiagnostic test
Physician diagnoses a history of asthma or eczema or allergic rhinitis
| Study group | Role | What they receive |
|---|---|---|
| Allergy pregnant women | Other | Not described Receives: Diagnostic Test: Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women |
| Health pregnant women | Other | Not described Receives: Diagnostic Test: Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from intestinal microbiome diversity between allergic pregnant mother and the non-allergic pregnant mother.
To detect the difference of the intestinal microbiome between allergic pregnant mother and the non-allergic pregnant mother using the next generation sequence (NGS).
Measured: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
Change from intestinal microbiome diversity between Infants born from allergic pregnant mothers or non-allergic pregnant mother.
To detect the difference of the intestinal microbiome between Infants born from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Measured: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
Change from intestinal microbiome diversity between Infants three months after birth from allergic pregnant mothers or non-allergic pregnant mother.
To detect the difference of the intestinal microbiome between Infants three months after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Measured: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
Change from intestinal microbiome diversity between Infants six months after birth from allergic pregnant mothers or non-allergic pregnant mother.
To detect the difference of the intestinal microbiome between Infants six months after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Measured: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
Change from intestinal microbiome diversity between Infants one year old after birth from allergic pregnant mothers or non-allergic pregnant mother.
To detect the difference of the intestinal microbiome between Infants one year old after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Measured: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
Change from intestinal microbiome diversity between Infants two year old after birth from allergic pregnant mothers or non-allergic pregnant mother.
To detect the difference of the intestinal microbiome between Infants two year old after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Measured: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Oct 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Difficulties in recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseasesStudies of the same condition, open and under way.
- More trials run by China Medical University 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Chih Lin, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873792
- Sponsor's protocol ID
- CMUH106-REC1-152
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Probiotics to Allergic Pregnant Mother and Their Offspring to Prevent Allergic Disease
- ClinicalTrials.gov ID
- NCT03873792
- Acronym / sponsor ID
- CMUH106-REC1-152
- Conditions
- Allergic Diseases
- Keywords
- Allergic diseases, Probiotics, Immunoglobulin E, Intestinal microbiota
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties in recruiting participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Mar 2019 (actual)
- 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 aim of the study is first to detect the difference of the intestinal microbiome between allergic pregnant mother and the non-allergic pregnant mother using the next generation sequence, all postnatal infants will collect the first meconium and feces from one, two, six months to one year old for the same test. The second stage of the study is to restore the allergic pregnant mother abnormal intestinal microbiome with probiotics trying to reduce the incidence of allergic disease of their offspring.
Detailed description
Allergic diseases are the largest group of non-communicable diseases (NCD) with an increasing prevalence in both the developed and developing world. There are significant bodies of research trying to examine the use of probiotics to prevent allergic disease. Though clinical randomized controlled trials and meta-analyses shows benefits of using probiotic supplements during pregnancy and early infant life to prevent the development of atopic dermatitis ; however, Cochrane review found that the benefit is not significant for immunoglobulin E (IgE) associated atopy. The lack of effectiveness that probiotics supplement to prevent allergic offspring to the allergic pregnant mother might due to too late to give probiotics and not give the appropriate probiotics. Investigators speculate that intestinal microbiota of allergic pregnant mother is different from the non-allergic pregnant mother. According to the theory that intestinal microbiome of pregnant mother might affect the offprint's intestinal microbiota during labor and further induce the allergic status.
The aim of the study is first to detect the difference of the intestinal microbiome between allergic pregnant mother and the non-allergic pregnant mother using the next generation sequence, all postnatal infants will collect the first meconium and feces from one, two, six months to one year old for the same test. The second stage of the study is to restore the allergic pregnant mother abnormal intestinal microbiome with probiotics trying to reduce the incidence of allergic disease of their offspring.
Allergic pregnant women who intend to breast- feed their infant are eligible to be enrolled in the study if she has a history of asthma or eczema treated or allergic rhinitis treated by a doctor. All infants born in the study are eligible for inclusion in study outcomes. Study probiotics containing Lactobacillus and Bifidobacterium, and the placebo capsules are made from glucose, both are manufactured by Taiwan Company. After inform consent, probiotics will give to the allergic pregnant women till delivery and infants will have probiotics for 6 months after born. Primary outcome is the prevalence of physician diagnosis atopic eczema and frequency of wheezing attack at 24 month of age.
Randomization is managed by computer at pharmacy of CMUH and concealed from all study staff and participants. An intention-to-treat analysis will be used to assess the effect of probiotics on the 24 month cumulative prevalence of eczema and SCORAD ≥10 using hazard ratios from a Cox's proportional hazards model, and the point prevalence of atopy at age 24 months using relative rates and a chi- squared test. Chi-square test will also be used to compare the proportion in each study group with detectable levels of immunological markers in breast milk. If the data is not log-normally distributed a Wilcoxon Rank-Sum test will be used. Reasons for withdrawal from the study will be recorded and examined for differences between study groups. Adjustment will be made for differences in antibiotic use between study groups. SAS version 9.4 will be used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergy pregnant women | Other | Diagnostic Test: Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women |
| Health pregnant women | Other | Diagnostic Test: Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- An adult pregnant mother who is over 20 years old and has a history of asthma or eczema or allergic rhinitis who is exercising autonomous consent.
- Pregnant women over 20 years old without allergies.
- Infants ≧ 37 weeks gestational age.
Key exclusion criteria (2 listed)
- Under 20 years old.
- Pregnant mothers and babies with congenital immune diseases.
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 |
|---|---|---|
| Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant womenPhysician diagnoses a history of asthma or eczema or allergic rhinitis | Diagnostic test | Allergy pregnant women, Health pregnant women |
Primary outcome
Change from intestinal microbiome diversity between allergic pregnant mother and the non-allergic pregnant mother.
Time frame: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
To detect the difference of the intestinal microbiome between allergic pregnant mother and the non-allergic pregnant mother using the next generation sequence (NGS).
Change from intestinal microbiome diversity between Infants born from allergic pregnant mothers or non-allergic pregnant mother.
Time frame: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
To detect the difference of the intestinal microbiome between Infants born from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Change from intestinal microbiome diversity between Infants three months after birth from allergic pregnant mothers or non-allergic pregnant mother.
Time frame: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
To detect the difference of the intestinal microbiome between Infants three months after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Change from intestinal microbiome diversity between Infants six months after birth from allergic pregnant mothers or non-allergic pregnant mother.
Time frame: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
To detect the difference of the intestinal microbiome between Infants six months after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Change from intestinal microbiome diversity between Infants one year old after birth from allergic pregnant mothers or non-allergic pregnant mother.
Time frame: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
To detect the difference of the intestinal microbiome between Infants one year old after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Change from intestinal microbiome diversity between Infants two year old after birth from allergic pregnant mothers or non-allergic pregnant mother.
Time frame: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
To detect the difference of the intestinal microbiome between Infants two year old after birth from allergic pregnant mothers or non-allergic pregnant mother using the NGS.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women in people with Allergic Diseases, run by China Medical University 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 21 Mar 2022. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from intestinal microbiome diversity between allergic pregnant mother and the non-allergic pregnant mother. (time frame: An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.). The study lists 6 primary outcomes in all. 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 21 Mar 2022.