What side effects are associated with this type of intervention?

Proton Pump Inhibitors (PPIs), such as omeprazole and esomeprazole, are commonly used to treat heartburn by reducing stomach acid production. Known side effects of PPIs include an increased risk of small intestinal bacterial overgrowth, higher incidence of adverse effects when combined with prokinetics, and potential for increased gastroesophageal reflux disease symptoms with certain medications like metoclopramide and ranitidine. Additionally, long-term use of PPIs may be associated with nutrient malabsorption, bone fractures, and kidney disease.

What prior FDA approvals exist?

Proton Pump Inhibitors (PPIs) are a class of drugs that have been approved by the FDA for the treatment of heartburn and gastroesophageal reflux disease (GERD). These medications work by reducing the production of stomach acid. Commonly approved PPIs include omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole. These drugs are effective in healing erosive esophagitis and providing symptomatic relief from heartburn by inhibiting the hydrogen-potassium ATPase enzyme system of the gastric parietal cells, thereby reducing gastric acid secretion.

What other types of research exist?

Promising novel alternatives to Proton Pump Inhibitors for heartburn treatment in 2024 include: 1) Alginate-based therapies, such as Gaviscon, which form a protective barrier to prevent acid reflux. 2) Prokinetics, which enhance gastrointestinal motility and reduce reflux episodes. 3) H2 receptor antagonists, like famotidine, which reduce stomach acid production and have shown efficacy in recent studies. These alternatives offer different mechanisms of action and may be suitable for patients who do not respond well to PPIs.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and after ppi therapy, approximately 8 weeks for reporting.

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

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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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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,298 Previous Clinical Trials

3,958,395 Total Patients Enrolled

Andree Koop, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Breath Test Evaluation for SIBO Clinical Trial Eligibility Overview. Trial Name: NCT05976165 — N/A

Acid Reflux Research Study Groups: Breath Test Evaluation for SIBO

Acid Reflux Clinical Trial 2023: Breath Test Evaluation for SIBO Highlights & Side Effects. Trial Name: NCT05976165 — N/A

Breath Test Evaluation for SIBO 2023 Treatment Timeline for Medical Study. Trial Name: NCT05976165 — N/A

~12 spots leftby Dec 2024

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