Status Approved
First Submitted Date
2020/05/20
Registered Date
2020/05/22
Last Updated Date
2020/05/20
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005049 |
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Unique Protocol ID | VC20OISI0047 |
Public/Brief Title | The effect of Helicobacter pylori eradication on small intestinal bacterial overgrowth: A prospective observational study |
Scientific Title | The effect of Helicobacter pylori eradication on small intestinal bacterial overgrowth: A prospective observational study |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | VC20OISI0047 |
Approval Date | 2020-04-09 |
Institutional Review Board Name | The Institutional Research Ethics Board of St. Vincent’s hospital, Catholic University of Korea |
Institutional Review Board Address | 93, Jungbu-daero, Paldal-gu, Suwon-si, Gyeonggi-do |
Institutional Review Board Telephone | 031-249-8289 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Chang-Nyol Paik |
Title | Professor |
Telephone | +82-31-881-8581 |
Affiliation | The Catholic University of Korea, St. Vincent's Hospital |
Address | 93, Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do |
Contact Person for Public Queries | |
Name | Dae Bum Kim |
Title | Assistant professor |
Telephone | +82-31-881-8582 |
Affiliation | The Catholic University of Korea, St. Vincent's Hospital |
Address | 93, Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do |
Contact Person for Updating Information | |
Name | Dae Bum Kim |
Title | Assistant professor |
Telephone | +82-31-881-8582 |
Affiliation | The Catholic University of Korea, St. Vincent's Hospital |
Address | 93, Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-02 Anticipated | |
Target Number of Participant | 156 | |
Primary Completion Date | 2022-03-31 , Anticipated | |
Study Completion Date | 2022-05-12 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | The Catholic University of Korea, St. Vincent's Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-02 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | IL-YANG Pharmaceuticals |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Korea, St. Vincent's Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Small intestinal bacterial overgrowth means an increase in the number of bacteria in the small bowel or an increase in the amount of abnormal types of bacteria, which can result in complex and diverse symptoms. Small intestinal bacterial overgrowth can show various symptoms of functional dyspepsia and irritable bowel syndrome, such as abdominal distension, gas, abdominal discomfort, diarrhea, and abdominal pain. In severe cases, symptoms of absorption disorders (weight loss, fat stool, malnutrition) may also appear. Helicobacter pylori damages the gastrointestinal mucosa defense system and reduces the secretion of gastric acid, Helicobacter pylori infection can cause small intestinal bacterial overgrowth with these mechanisms. Previous studies have reported that Helicobacter pylori infection is associated with small intestinal bacterial overgrowth, and also reports a high incidence of small intestinal bacterial overgrowth in patients treated with Helicobacter pylori infection. Proton pump inhibitors used for Helicobacter pylori eradication can inhibit gastric acid and cause small intestinal bacteria overgrowth, and the antibiotics included in the treatment can contribute to the growth of small intestinal bacteria by inducing the proliferation of non-helicobacter pylori. Previous studies have reported that the incidence of small intestinal bacterial overgrowth is high in patients who have simply been treated with Helicobacter pylori, but it is not clear whether the actual bactericidal treatment treats or induces small intestinal bacterial overgrowth. There is also controversy in recent studies as to whether proton pump inhibitors cause small intestinal bacterial overgrowth. Therefore, in this study, we investigated the effect of Helicobacter pylori eradication on small intestinal bacterial overgrowth in patients with Helicobacter pylori infection. In addition, we evaluate the changes in small intestinal bacterial overgrowth in patients who have taken proton pump inhibitor alone, patterns of glucose breath test, and changes in concentration of breath hydrogen and methane. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 156 |
Cohort/Group Number | 3 |
Cohort/ Group 1 |
Cohort/Group Label Patient with functional gastrointestinal symptoms who have Helicobacter pylori infection and small intestinal bacterial overgrowth |
Cohort/Group Description In patients diagnosed with Helicobacter pylori infection and small intestinal bacterial overgrowth after endoscopy and glucose breath test performed for functional gastrointestinal symptoms, Helicobacter pylori status, glucose breath test, and changes of symptoms were monitored after 4 weeks after Helicobacter pylori eradication. |
|
Cohort/ Group 2 |
Cohort/Group Label Patient with functional gastrointestinal symptoms who have Helicobacter pylori infection but no small intestinal bacterial overgrowth |
Cohort/Group Description In patients diagnosed with Helicobacter pylori infection but negative results of small intestinal bacterial overgrowth after endoscopy and glucose breath test performed for functional gastrointestinal symptoms, Helicobacter pylori status, glucose breath test, and changes of symptoms were monitored after 4 weeks after Helicobacter pylori eradication. |
|
Cohort/ Group 3 |
Cohort/Group Label Patient with functional gastrointestinal symptoms without Helicobacter pylori infection and without small intestinal bacterial overgrowth |
Cohort/Group Description In patients without both Helicobacter pylori infection and small intestinal bacterial overgrowth after endoscopy and glucose breath test performed for functional gastrointestinal symptoms, glucose breath test and changes of symptoms were monitored after 4 weeks after proton pump inhibitor therapy. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients between the ages of 20 and 70 who visited with functional gastrointestinal symptoms and performed endoscopy for Helicobacter pylori infection and glucose breath test |
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Sampling Method | Non-probablity sampling: A complete enumeration of patients between the ages of 20 and 70 who visited with functional gastrointestinal symptoms and performed endoscopy for Helicobacter pylori infection and glucose breath test |
Condition(s)/Problem(s) |
* (K00-K93)Diseases of the digestive system (K92.9)Disease of digestive system, unspecified Functional gastrointestinal disease Helicobacter pylori infection Small intestinal bacterial overgrowth |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~70Year |
|
Description 1) patients of age 20 to 70 2) patients who visited with functional gastrointestinal symptoms and performed endoscopy for Helicobacter pylori infection and glucose breath test |
|
Exclusion Criteria |
1) Patients who were treated with antibiotics within 3 months 2) Patients diagnosed with gastrointestinal stricture or obstruction at the endoscopy or upper gastrointestinal series 3) Patients with previous gastrointestinal surgery, except for appendectomy 4) Patients who have gastrointestinal bleeding, mechanical obstruction, or perforation 5) Patients who have severe organ dysfunction, such as renal dysfunction or hepatic dysfunction 6) Patients who were treated with medication, such as prokinetics, histamine receptor antagonists, proton pump inhibitors, anticholinergics, antidepressant within 2 weeks before the study 7) Allergic reaction for experimental medicine 8) Improper patient in the study, according to judgement of researcher |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Changes in small intestinal bacterial overgrowth after Helicobacter pylori eradication |
|
Timepoint | at 4 weeks after completion of treatment |
|
Secondary Outcome(s) 1 | ||
Outcome | The results of glucose breath test |
|
Timepoint | at 4 weeks after completion of treatment |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2022. 12 |
Way of Sharing | Available on Request
(drkimble@hanmail.net) |
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