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Vaginal Seeding for Allergies and Asthma in C-section Infants
Phase < 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up infants at 3 months and 12 months of age (=month 3 and -12 visits)
Awards & highlights
Study Summary
This trial is looking to see if it's effective to swab C-section babies with a gauze pad that has been dipped in the mother's vagina just after birth.
Who is the study for?
This trial is for pregnant women planning a C-section who understand the study and consent to participate. Their babies must have a relative with allergies or asthma, but can't join if there's labor before the C-section, water breaks early, high vaginal pH, or certain infections like HIV or hepatitis. Moms with serious health issues or on certain medications are also excluded.Check my eligibility
What is being tested?
The study tests whether exposing C-section newborns to their mother's vaginal bacteria (vaginal seeding) might reduce allergy and asthma risk compared to placebo seeding or standard care. It explores how this exposure could influence the baby’s immune system by comparing these three approaches.See study design
What are the potential side effects?
Potential side effects aren't specified for this trial since it involves natural bacterial exposure rather than drugs; however, there may be risks associated with handling and transferring maternal bacteria which will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ infants at 3 months and 12 months of age (=month 3 and -12 visits)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~infants at 3 months and 12 months of age (=month 3 and -12 visits)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence of Sensitization to at Least One Food Allergen at 12 months of age - by Treatment Group
Secondary outcome measures
Level of Allergen-Specific Atopy at 12 months of age - by Treatment Group
Level of Combined Allergen-Specific Atopy at 12 Months of Age - by Treatment Group
Number of Food Allergens and Aeroallergens Each Infant is Sensitized to at 12 Months of Age-by Treatment Group
+3 moreOther outcome measures
EXPLORATORY: Comparison by Treatment Group in Bacterial Composition of the Infant Microbiome
EXPLORATORY: Comparison by Treatment Group in Fungal Composition of the Infant Microbiome
EXPLORATORY: Comparison by Treatment Group in Immunomodulatory Influences of the Fecal Metabolome
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: C-section -Vaginal seedingExperimental Treatment1 Intervention
Pregnant women who undergo C-section and (neonate) vaginal seeding.
Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with gauze containing their mother's vaginal microbiota just after delivery.
Group II: C-section - Placebo SeedingExperimental Treatment1 Intervention
Pregnant women who undergo C-section and (neonate) placebo seeding.
Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with sterile gauze (placebo).
Group III: standard careActive Control1 Intervention
Pregnant women who undergo spontaneous vaginal delivery (of neonate) .
Pregnant women who undergo spontaneous vaginal delivery and (neonate) receives standard care.
Find a Location
Who is running the clinical trial?
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,798 Total Patients Enrolled
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191 Patients Enrolled for Asthma
Rho Federal Systems Division, Inc.Industry Sponsor
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13,489 Total Patients Enrolled
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1,217 Patients Enrolled for Asthma
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,348 Total Patients Enrolled
58 Trials studying Asthma
11,415 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby needed extra help beyond normal care after birth.I do not have an active STI, yeast infection, or vaginosis on the day of delivery.I have a history of inflammatory bowel disease.I am a mother with a serious long-term health condition during my pregnancy.I used experimental drugs in the last 3 months of my pregnancy.I used medication or a Foley catheter for labor induction.I have had diabetes or diabetes during pregnancy.I have taken antibiotics in the last trimester of my current pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: C-section - Placebo Seeding
- Group 2: C-section -Vaginal seeding
- Group 3: standard care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has this investigation recruited?
"Affirmative. The information on clinicaltrials.gov testifies that this research trial, which was first posted in November of 2018, is actively enrolling patients. Around 120 individuals are required to be recruited from two medical facilities."
Answered by AI
Is the age criterion for eligibility in this research trial set at 18 years or older?
"This research project is only enrolling individuals between the ages of 18 and 45. On the other hand, there are 116 studies available for minors and 198 trials that cater to older patients who exceed 65 years old."
Answered by AI
Are there any vacancies remaining for this research project?
"Indeed, the information available on clinicaltrials.gov confirms that this trial is still recruiting participants. It was initially posted to the website on November 28th 2018 and its most recent edit took place on September 28th 2022. Two distinct medical centres are in need of 120 patients for this study."
Answered by AI
What kind of individuals are appropriate candidates for this experiment?
"This research trial is seeking 120 individuals aged 18 to 45 who are diagnosed with asthma. Prospective participants must meet the following criteria: Atopic disease (e.g., asthma, allergic rhinoconjunctivitis or atopic dermatitis) and/or a food allergy in their immediate family; exceptions will be made for pregnant women carrying singleton pregnancies of an appropriately-grown fetus."
Answered by AI
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