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Breath Testing for Gut Bacteria Imbalance
N/A
Recruiting
Led By Andree Koop, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial aims to find out how common gut bacteria imbalance is in people taking acid-reducing medications. #guthealth
Who is the study for?
This trial is for individuals with symptoms of gastroesophageal reflux disease (GERD) like heartburn and regurgitation, who can consent to the study. It's not for those with prior GI surgery, pregnant or breastfeeding women, recent users of PPIs/H2R-antagonists or antibiotics, diagnosed IBS/IBD patients, those planning pregnancy, or unable to take PPIs due to allergies.Check my eligibility
What is being tested?
The study is testing breath analysis as a method to detect small intestinal bacterial overgrowth in people who have taken proton pump inhibitors. The goal is to see how common this condition is among GERD sufferers after using these medications.See study design
What are the potential side effects?
Since the intervention involves non-invasive breath testing, significant side effects are not anticipated. However, some discomfort from bloating may occur during the test due to ingestion of substances needed for accurate measurement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after ppi therapy, approximately 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after ppi therapy, approximately 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of SIBO after treatment with PPI
Secondary outcome measures
Incidence of SIBO before treatment with a PPI
Symptoms of SIBO after treatment with PPI
Symptoms of SIBO before treatment with a PPI
Trial Design
1Treatment groups
Experimental Treatment
Group I: Breath Test Evaluation for SIBOExperimental Treatment1 Intervention
Subjects with symptoms of gastroesophageal reflux disease (GERD) treated with a short course of proton pump inhibitors (PPI) clinically will undergo breath testing evaluating for small intestinal bacterial overgrowth (SIBO).
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,438 Total Patients Enrolled
Andree Koop, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken antibiotics in the last month.I have been diagnosed with irritable or inflammatory bowel disease.I often experience heartburn and acid reflux.I have had surgery on my digestive system.I have used acid reflux medication in the last 3 months.I cannot take PPI medications due to an allergy or sensitivity.I do not have major kidney, liver, joint, heart diseases, or another type of cancer.I have been diagnosed with small intestine bacterial overgrowth.
Research Study Groups:
This trial has the following groups:- Group 1: Breath Test Evaluation for SIBO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is it still feasible for individuals to apply to this research trial?
"According to clinicaltrials.gov, this trial is not currently accepting any new candidates as the last update was on July 27th 2023. However, there are still 72 other trials that are actively seeking participants at this time."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I can’t find a dr who has been able to help me with my SIBO vim in great pain from the bacterial overgrowth. I can’t afford the medication needed to treat me.
PatientReceived no prior treatments
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