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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
No Placebo-Only Group
Summary
This trial aims to find out how often patients taking proton pump inhibitors experience an increase in small intestinal bacterial overgrowth.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of SIBO after treatment with PPI
Secondary study objectives
Incidence of SIBO before treatment with a PPI
Symptoms of SIBO after treatment with PPI
Symptoms of SIBO before treatment with a PPI
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Proton Pump Inhibitors (PPIs) are a class of medications that reduce stomach acid production by blocking the enzyme system of gastric proton pumps. This reduction in acid production helps to alleviate heartburn symptoms by preventing acid from irritating the esophagus.
PPIs are particularly effective for patients with gastroesophageal reflux disease (GERD) as they provide longer-lasting relief compared to other treatments like antacids or H2 blockers. Understanding the mechanism of PPIs is crucial for heartburn patients because it highlights the importance of acid suppression in managing their symptoms and preventing potential complications such as esophagitis.
The effects of baclofen for the treatment of gastroesophageal reflux disease: a meta-analysis of randomized controlled trials.
The effects of baclofen for the treatment of gastroesophageal reflux disease: a meta-analysis of randomized controlled trials.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,350 Previous Clinical Trials
3,060,624 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.
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