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Probiotics
Probiotics for Obese Asthmatics with Insulin Resistance
N/A
Waitlist Available
Led By Jessy Deshane, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
All patients will be obese asthmatics with a body mass index >30 and insulin resistance >5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test if oral probiotics help improve asthma symptoms in obese insulin resistant people.
Who is the study for?
This trial is for obese adults over 18 with asthma and insulin resistance. Participants must have a BMI >30, stable asthma without medication changes for 3 months, and an insulin resistance score >5. It's not open to pregnant individuals or those who can't consent, have had recent severe asthma attacks or other lung diseases.Check my eligibility
What is being tested?
The study tests if oral probiotics can change the airway microbiome/metabolome in these patients, reduce leptin and insulin resistance levels, lead to weight loss, and improve asthma outcomes compared to a placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, probiotics are generally considered safe but may cause digestive discomfort such as gas or bloating in some people.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I am obese with a BMI over 30 and have insulin resistance greater than 5.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine if microbiome/metabolome changes in probiotics group correlates with changes in asthma biomarkers and improved clinical outcomes compared to placebo in obese insulin resistant asthmatics
Determine if modulation of leptin levels and insulin sensitivity by probiotics administration correlates with airway metabolome alterations and weight loss in obese insulin resistant asthmatics
Determine if probiotic administration modulates airway microbiome/metabolome in obese insulin resistant asthmatics
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
Subjects will receive a probiotic supplement to take by mouth daily.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive a placebo to take by mouth daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,024 Total Patients Enrolled
5 Trials studying Asthma
40,959 Patients Enrolled for Asthma
American Lung AssociationOTHER
31 Previous Clinical Trials
10,953 Total Patients Enrolled
13 Trials studying Asthma
3,379 Patients Enrolled for Asthma
Jessy Deshane, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I needed oral steroids for asthma for more than 3 days recently.I was hospitalized for asthma within the last 3 months.I am obese with a BMI over 30 and have insulin resistance greater than 5.My asthma is stable and my medications haven't changed in the last 3 months.I understand the study procedures and can give informed consent.I have a lung condition that is not asthma.
Research Study Groups:
This trial has the following groups:- Group 1: Probiotic
- Group 2: Placebo
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.
Would I be eligible to partake in this experiment?
"Candidates aged 18 to 99 years old, who possess insulin resistance, are eligible for this medical test. Twenty participants will be taken into consideration."
Answered by AI
Does this research study have an age restriction, and if so, what is it?
"Participants in this medical trial need to be aged 18 or older, yet not more than 99 years old."
Answered by AI
Are there still openings for this experiment?
"After consulting clinicaltrials.gov, it is clear that this particular medical study has stopped recruiting as of July 7th 2023; its initial posting was on 15/7/2023. Fortunately, there are 1435 other trials actively calling for volunteers at the moment."
Answered by AI
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