UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057136 |
|---|---|
| Receipt number | R000065308 |
| Scientific Title | Pathophysiological analysis of small intestinal bacterial overgrowth (SIBO) |
| Date of disclosure of the study information | 2025/02/26 |
| Last modified on | 2025/02/26 11:13:47 |
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Basic information
Public title
Pathophysiological analysis of small intestinal bacterial overgrowth (SIBO)
Acronym
Pathophysiology of small intestinal bacterial overgrowth (SIBO)
Scientific Title
Pathophysiological analysis of small intestinal bacterial overgrowth (SIBO)
Scientific Title:Acronym
pathophysiology of small intestinal bacterial overgrowth (SIBO)
Region
| Japan |
Condition
Condition
Small intestinal bacterial overgrowth (SIBO)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Perform breath tests on patients with clinically suspected SIBO to clarify its pathophysiology in Japanese.
Basic objectives2
Others
Basic objectives -Others
Creation of evidence for Japanese SIBO.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive diagnostic rate of breath test as the gold standard for SIBO diagnosis by bacterial count.
Sensitivity, specificity, positive predictive value, and negative predictive value of breath test.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients suspected of having SIBO
(1) Patients with abdominal symptoms such as abdominal distention and abdominal pain.
(2) Patients with abnormal gas in the small intestine on plain abdominal X-ray or CT scan performed for medical reasons.
(3) No evidence of organic disease (tumor, acute ulcerative lesion, severe stenosis or obstruction, etc.) on abdominal ultrasonography or upper gastrointestinal endoscopy performed for medical necessity.
(4) No antimicrobial agents have been administered for 3 months prior to obtaining consent to participate in this study.
(5) Age between 18 and 90 years old.
(6) Consent for participation in this study is obtained from the patient by signing a consent form.
Key exclusion criteria
(1) Patients with a history of surgical operation for gastrointestinal diseases except for cholecystectomy, appendectomy, and hemorrhoidectomy.
(2) Patients who have taken intestinal antiflatulents or intestinal peristaltic drugs within 1 month.
(3) Those who have taken antibiotics within 3 months.
(4) Diabetic patients with poor glycemic control (HbA1c >= 7.0%).
(5) Patients taking alpha-glucosidase inhibitors.
(6) Pregnant or possibly pregnant.
(7) Patients with organic diseases (tumor, acute ulcerative lesion, severe stenosis or obstruction, etc.).
(8) Other patients who are deemed inappropriate by the principal investigator and the study administrator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Suzuki |
Organization
Tokai University Hachioji Hospital
Division name
Department of gastroenterology
Zip code
192-0032
Address
1838 Ishikawa machi, Hachioji, Tokyo
TEL
042-639-1111
takayosh@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Suzuki |
Organization
Tokai University Hachioji Hospital
Division name
Department of gastroenterology
Zip code
192-0032
Address
1838 Ishikawa machi, Hachioji, Tokyo
TEL
042-639-1111
Homepage URL
takayosh@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee, Tokai University school of medicine
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rec@tokai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study subjects are patients who visited the Department of Gastroenterology at Hachioji Hospital have abdominal symptoms, and are suspected of having SIBO.
Management information
Registered date
| 2025 | Year | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065308
