A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

Gastroesophageal Reflux Clinical Trial

Official title:

Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976165
• Other study ID #: 22-007268
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Heartburn
• Regurgitation

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