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A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

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ClinicalTrials.gov Identifier: NCT05976165
Recruitment Status : Recruiting
First Posted : August 4, 2023
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Andree H. Koop, Mayo Clinic

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : November 17, 2023
Estimated Primary Completion Date : May 17, 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of SIBO after treatment with PPI [ Time Frame: 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 [ Time Frame: 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. Other questionnaires include a diarrhea survey and the GERDQ.

  2. Incidence of SIBO before treatment with a PPI [ Time Frame: 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 [ Time Frame: 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. Other questionnaires include a diarrhea survey and the GERDQ.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05976165


Locations
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United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Andree H Koop, MD    904-953-3970    koop.andree@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Andree Koop, MD Mayo Clinic
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Andree H. Koop, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05976165    
Other Study ID Numbers: 22-007268
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andree H. Koop, Mayo Clinic:
Proton pump inhibitor
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive