Health TrialsbyHealthPanel

A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

ConditionsGastroesophageal RefluxRegurgitationHeartburn
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation

Subjects must be able to give appropriate informed consent

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Breath Testing

    Other intervention

    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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Breath Test Evaluation for SIBOExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

Symptoms of SIBO before treatment with a 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
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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