Efficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome

Irritable bowel syndrome is characterized by abdominal discomfort and bowel habit change. It is increasing worldwide. But the pathophysiology of the irritable bowel syndrome is not proven. So, the treatment's target is the relief of the symptoms.

Small intestinal bacterial overgrowth considered as the cause of the irritable bowel syndrome. Because, it is related to the postprandial abdominal discomfort and the abdominal discomfort could be relieved after taking antibiotics. There are several diagnostic methods for small intestinal bacterial overgrowth. hydrogen breath test is non-invasive method for diagnosis of the small intestinal bacterial overgrowth. But, there is no standardized cut-off value for the hydrogen breath test. So, we want to compare the hydrogen breath test between the irritable bowel syndrome patients and normal people. And then, we want to analyze the efficacy of hydrogen breath test for the diagnosis of irritable bowel syndrome.

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Device: Glucose breath test (hydrogen breath test)

• Study Type: Interventional
• Enrollment (Anticipated): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Sevrance Hospital
    • Contact: Yong Chan Lee, MD; Phone Number: 82-2-2228-1960; Email: leeyc@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. over 19 years old, male and female
2. normal people (control group, who has no abdominal symptoms - diarrhea, constipation etc.)
3. irritable bowel syndrome patients (irritable bowel syndrome means that within the last 3 months abdominal discomfort more than three days for a month and satisfies over the below two items) 1) symptom relived after defecation 2) bowel habit change, the times of defecation changed 3) the change of the morphology of the stool

Exclusion Criteria:

1. patients who do not agree for participation
2. patients who have history for treatment of irritable bowel syndrome
3. patients who is uncontrolled diabetes mellitus
4. patients who have small bowel or large bowel diseases
5. patients who had surgery for abdomen
6. patients who are taking antibiotics, anti-depressants within 1 week
7. patients who are taking proton pump inhibitors or opioids for analgesics
8. patients who have history of bowel adhesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: normal group	Device: Glucose breath test (hydrogen breath test); Glucose breath test (hydrogen breath test) is the current gold standard for diagnosis of irritable bowel syndrome. Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen or methane gas as a by-product. The breath sample will be analyzed for hydrogen or methane content to determine if you are able to properly break down the lactose, fructose or sucrose, or if you have bacterial overgrowth.
OTHER: irritable bowel syndrome group	Device: Glucose breath test (hydrogen breath test); Glucose breath test (hydrogen breath test) is the current gold standard for diagnosis of irritable bowel syndrome. Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen or methane gas as a by-product. The breath sample will be analyzed for hydrogen or methane content to determine if you are able to properly break down the lactose, fructose or sucrose, or if you have bacterial overgrowth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people	The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people	Within the 24 hours after 8-12 hours fasting

Secondary Outcome Measures

Outcome Measure	Time Frame
The difference of methane level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people	Within the 24 hours after 8-12 hours fasting

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: September 14, 2014
• First Submitted That Met QC Criteria: September 14, 2014
• First Posted (ESTIMATE): September 16, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 1-2014-0046