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

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02242175
• Other study ID #: 1-2014-0046
• Status: Recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 2020

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Yong Chan Lee, MD
• Phone: 82-2-2228-1960
• Email: leeyc[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 147
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Sevrance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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