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

NCT ID: NCT02242175

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2020-08-31

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

normal group

Group Type: OTHER

Glucose breath test (hydrogen breath test)

Intervention Type: DEVICE

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.

irritable bowel syndrome group

Group Type: OTHER

Glucose breath test (hydrogen breath test)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sevrance hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yong Chan Lee, MD

Role: CONTACT

leeyc@yuhs.ac

82-2-2228-1960

Facility Contacts

Yong Chan Lee, MD

Role: primary

leeyc@yuhs.ac

82-2-2228-1960

Other Identifiers

1-2014-0046

Identifier Type: -

Identifier Source: org_study_id