Recruiting NCT05976165
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breath Testing.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux, Regurgitation, Heartburn. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
Overview
Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.
Interventions
- Other Breath Testing
Subjects drink a small carbohydrate solution, and then provide a breath sample every 15 minutes for one hour, and then every 30 minutes for the next two hours
Primary outcome measures
- Incidence of SIBO after treatment with PPI [Time frame: After PPI therapy, approximately 8 weeks]
Secondary outcome measures (3)
- Symptoms of SIBO after treatment with PPI [Time frame: After PPI therapy, approximately 8 weeks]
- Incidence of SIBO before treatment with a PPI [Time frame: Baseline]
- Symptoms of SIBO before treatment with a PPI [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
- Subjects must be able to give appropriate informed consent
Exclusion criteria
- Prior diagnosis of SIBO
- Use of PPIs or H2R-anatagonstists in the prior 3 months
- Major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or malignancy)
- Antibiotic therapy within one month
- Prior gastrointestinal surgery including esophageal, gastric, and small or large bowel surgery
- Previously diagnosed irritable bowel syndrome or inflammatory bowel disease
- Individuals who are pregnant or breast feeding
- Patients with plans to become pregnant
- Inability to take PPIs, including allergy/sensitivity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic Florida — Jacksonville
Identifiers
NCT: NCT05976165 · 22-007268