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

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ClinicalTrials.gov Identifier: NCT02242175
Recruitment Status : Recruiting
First Posted : September 16, 2014
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Device: Glucose breath test (hydrogen breath test) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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 ]
    The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people


Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02242175


Contacts
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Contact: Yong Chan Lee, MD 82-2-2228-1960 leeyc@yuhs.ac

Locations
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Korea, Republic of
Sevrance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yong Chan Lee, MD    82-2-2228-1960    leeyc@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02242175     History of Changes
Other Study ID Numbers: 1-2014-0046
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases