Back to resultsEfficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Glucose breath test (hydrogen breath test)
Sponsored by
About this trial
This is an interventional diagnostic trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- over 19 years old, male and female
- normal people (control group, who has no abdominal symptoms - diarrhea, constipation etc.)
- 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:
- patients who do not agree for participation
- patients who have history for treatment of irritable bowel syndrome
- patients who is uncontrolled diabetes mellitus
- patients who have small bowel or large bowel diseases
- patients who had surgery for abdomen
- patients who are taking antibiotics, anti-depressants within 1 week
- patients who are taking proton pump inhibitors or opioids for analgesics
- patients who have history of bowel adhesion
Sites / Locations
- Sevrance hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
normal group
irritable bowel syndrome group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The difference of methane level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02242175
Brief Title
Efficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
147 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normal group
Arm Type
Other
Arm Title
irritable bowel syndrome group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Glucose breath test (hydrogen breath test)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
Description
The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
Time Frame
Within the 24 hours after 8-12 hours fasting
Secondary Outcome Measure Information:
Title
The difference of methane level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
Time Frame
Within the 24 hours after 8-12 hours fasting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
over 19 years old, male and female
normal people (control group, who has no abdominal symptoms - diarrhea, constipation etc.)
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:
patients who do not agree for participation
patients who have history for treatment of irritable bowel syndrome
patients who is uncontrolled diabetes mellitus
patients who have small bowel or large bowel diseases
patients who had surgery for abdomen
patients who are taking antibiotics, anti-depressants within 1 week
patients who are taking proton pump inhibitors or opioids for analgesics
patients who have history of bowel adhesion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Chan Lee, MD
Phone
82-2-2228-1960
Email
leeyc@yuhs.ac
Facility Information:
Facility Name
Sevrance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Chan Lee, MD
Phone
82-2-2228-1960
Email
leeyc@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome
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