A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

Mayo Clinic50 enrolled

Overview

Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Regurgitation Heartburn

Interventions

Breath TestingOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic Florida

Jacksonville, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of SIBO after treatment with PPI

Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).

Time frame: After PPI therapy, approximately 8 weeks

Secondary Outcomes

Symptoms of SIBO after treatment with PPI

Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention. Other questionnaires include a diarrhea survey and the GERDQ.

Time frame: After PPI therapy, approximately 8 weeks

Incidence of SIBO before treatment with a PPI

Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).

Time frame: Baseline

Symptoms of SIBO before treatment with a PPI

Time frame: Baseline

Data from ClinicalTrials.gov

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