A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05976165
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux; Regurgitation; Heartburn	Other: Breath Testing	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breath Test Evaluation for SIBO Subjects with symptoms of gastroesophageal reflux disease (GERD) treated with a short course of proton pump inhibitors (PPI) clinically will undergo breath testing evaluating for small intestinal bacterial overgrowth (SIBO).	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

Outcome Measures

Primary Outcome Measures

1. Incidence of SIBO after treatment with PPI [After PPI therapy, approximately 8 weeks]

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

Secondary Outcome Measures

1. Symptoms of SIBO after treatment with PPI [After PPI therapy, approximately 8 weeks]

   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.

2. Incidence of SIBO before treatment with a PPI [Baseline]

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

3. Symptoms of SIBO before treatment with a PPI [Baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation

• Subjects must be able to give appropriate informed consent

Exclusion criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Andree Koop, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Andree H. Koop, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05976165
• Other Study ID Numbers: 22-007268
• First Posted: Aug 4, 2023
• Last Update Posted: Aug 4, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andree H. Koop, Principal Investigator, Mayo Clinic: Proton pump inhibitor
• Additional relevant MeSH terms: Gastroesophageal Reflux; Heartburn

Study Results

No Results Posted as of Aug 4, 2023