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

NCT03873792 | Withdrawn

• 1 other identifier: CMUH106-REC1-152
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Diseases

Keywords

Allergic diseases; Probiotics; Immunoglobulin E; Intestinal microbiota

Outcome Measures

Primary Outcomes (6)

• 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).

  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.

  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.

  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.

  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.

  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.

  An average of 2 years for analysis of intestinal microbiome proportion such as Lactobacillus, Bifidobacterium and other genuses.

Study Arms (2)

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

Interventions

Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women DIAGNOSTIC_TEST

Physician diagnoses a history of asthma or eczema or allergic rhinitis

Allergy pregnant women; Health pregnant women

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Under 20 years old.
• Pregnant mothers and babies with congenital immune diseases.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Pediatrics, Children Hospital, China Medical University

Taichung, 404, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 13, 2019
• Study Start: October 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

TW (1)