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

NCT02242175 | Unknown

• 1 other identifier: 1-2014-0046
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

normal group

OTHER

Device: Glucose breath test (hydrogen breath test)

irritable bowel syndrome group

OTHER

Device: Glucose breath test (hydrogen breath test)

Interventions

Glucose breath test (hydrogen breath test) 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; normal group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Sevrance hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Yong Chan Lee, MD

CONTACT

82-2-2228-1960; leeyc@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

KR (1)