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Probiotic
Probiotics for Preventing Asthma in Infants
N/A
Waitlist Available
Led By Michael D. Cabana, MD, MPH
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from birth to 3 years of age
Awards & highlights
Study Summary
This trial will test whether daily supplementation of Lactobacillus GG protects against the development of asthma.
Who is the study for?
This trial is for newborns with at least one parent who has asthma. Parents must be willing to give their baby a daily probiotic supplement or placebo for the first six months of life. Babies with siblings in the study, those involved in other studies, from multiple births, or with birth defects or illnesses affecting food intake can't participate.Check my eligibility
What is being tested?
Researchers are testing if giving babies Lactobacillus GG (a probiotic) every day for six months helps prevent asthma by influencing their immune system development. This is done through a randomized controlled study where half get the probiotic and half get a fake pill without knowing which one they received.See study design
What are the potential side effects?
Probiotics are generally considered safe but may cause digestive upset like gas or bloating, especially when first starting them. In rare cases, people might experience allergic reactions or infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured from birth to 3 years of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from birth to 3 years of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Development of atopic dermatitis
Secondary outcome measures
Early clinical markers of asthma, including frequent wheezing, wheezing without upper or lower respiratory tract infections, allergic rhinitis, atopic dermatitis, serum IgE, and eosinophilia
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: 1Active Control1 Intervention
Participants in this arm will receive Lactobacillus GG.
Group II: 2Placebo Group1 Intervention
Participants in this arm will receive a placebo.
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,293 Total Patients Enrolled
276 Trials studying Asthma
112,348 Patients Enrolled for Asthma
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
581,993 Total Patients Enrolled
15 Trials studying Asthma
2,797 Patients Enrolled for Asthma
Michael D. Cabana, MD, MPHPrincipal InvestigatorAlbert Einstein College of Medicine
2 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Asthma
64 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to add a probiotic or placebo to my child's daily feeding for 6 months.I do not have birth defects, recent severe illnesses, or chronic conditions affecting my eating or metabolism.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
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.
Are clinical opportunities still available for individuals interested in participating?
"The current status posted on clinicaltrials.gov indicates that this trial is not recruiting patients; it was initially announced in June of 2005, and the latest update to its information occurred May 3rd 2022. Despite being closed for recruitment, there are 325 other trials taking participants at present time."
Answered by AI
May adults over the age of 30 participate in this clinical examination?
"This medical trial is only open to neonates aged between 1 Day and 4 Days. Those younger than 18 are eligible for 119 other studies, while those over 65 can take part in 199 different clinical trials."
Answered by AI
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