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Oral Probiotics to Allergic Pregnant Mother and Their Offspring to Prevent Allergic Disease

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ClinicalTrials.gov Identifier: NCT03873792
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hung-Chih Lin, China Medical University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Allergic Diseases Diagnostic Test: Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Oral Probiotics to Allergic Pregnant Mother and Their Offspring to Prevent Allergic Disease
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Allergy pregnant women Diagnostic Test: Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women
Physician diagnoses a history of asthma or eczema or allergic rhinitis

Health pregnant women Diagnostic Test: Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women
Physician diagnoses a history of asthma or eczema or allergic rhinitis




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873792


Contacts
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Contact: Hung-chih Lin 886-4-22052121 ext 4640 d0373@mail.cmuh.org.tw

Locations
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Taiwan
Department of Pediatrics, Children Hospital, China Medical University Recruiting
Taichung, Taiwan, 404
Contact: Hung-chih Lin    886-4-22052121 ext 4640    d0373@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital

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Responsible Party: Hung-Chih Lin, Attending physician, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03873792     History of Changes
Other Study ID Numbers: CMUH106-REC1-152
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hung-Chih Lin, China Medical University Hospital:
Allergic diseases
Probiotics
Immunoglobulin E
Intestinal microbiota