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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05976165
Other study ID # 22-007268
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 17, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Mayo Clinic Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 ). After PPI therapy, approximately 8 weeks
Secondary 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. After PPI therapy, approximately 8 weeks
Secondary 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 ). Baseline
Secondary 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. Baseline
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