- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03873792
Oral Probiotics to Allergic Pregnant Mother and Their Offspring to Prevent Allergic Disease
Study Overview
Status
Conditions
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan, 404
- Department of Pediatrics, Children Hospital, China Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Under 20 years old.
- Pregnant mothers and babies with congenital immune diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Allergy pregnant women
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Physician diagnoses a history of asthma or eczema or allergic rhinitis
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Other: Health pregnant women
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Physician diagnoses a history of asthma or eczema or allergic rhinitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
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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.
|
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.
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.
|
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.
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.
|
An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
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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.
|
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.
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.
|
An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMUH106-REC1-152
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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