UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051617 |
|---|---|
| Receipt number | R000058898 |
| Scientific Title | Prospective sampling, multicenter study to investigate clinical data and intestinal environment of patients with unexplained abdominal symptoms to explore the association with treatment efficacy and prognosis. |
| Date of disclosure of the study information | 2023/07/16 |
| Last modified on | 2024/04/24 11:23:07 |
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Basic information
Public title
Prospective sampling, multicenter study to investigate clinical data and intestinal environment of patients with unexplained abdominal symptoms to explore the association with treatment efficacy and prognosis.
Acronym
The study to investigate clinical data and intestinal environment of patients with unexplained abdominal symptoms to explore the association with treatment efficacy and prognosis.
Scientific Title
Prospective sampling, multicenter study to investigate clinical data and intestinal environment of patients with unexplained abdominal symptoms to explore the association with treatment efficacy and prognosis.
Scientific Title:Acronym
The study to investigate clinical data and intestinal environment of patients with unexplained abdominal symptoms to explore the association with treatment efficacy and prognosis.
Region
| Japan |
Condition
Condition
The patients with unexplained abdominal symptoms
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will investigate QOL in patients with unexplained abdominal symptoms and patients without abdominal symptoms at each institution in a multicenter setting. In addition, stool samples will be collected to compare bile acid concentrations in the stools of each patient, and to clarify the relationship between the intestinal environment and treatment efficacy and long-term prognosis.
Basic objectives2
Others
Basic objectives -Others
This study will investigate QOL in patients with unexplained abdominal symptoms and patients without abdominal symptoms at each institution in a multicenter setting. In addition, stool samples will be collected to compare bile acid concentrations in the stools of each patient, and to clarify the relationship between the intestinal environment and treatment efficacy and long-term prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total bile acid concentration in stool
Key secondary outcomes
Biochemical markers (TP, Alb, AST, ALT, GTP, BUN, Cre, UA, CRP, TG, T-cho, LDL-C, endotoxin, various antibodies, various vitamins, etc.)
-Hematological examination (WBC, Hb, Plt, PT, APTT, erythrocyte sedimentation rate, etc.)
-Blood metabolome analysis
-Hydrogen breath test
Lactulose-mannitol test
Imaging findings (abdominal x-ray with Schitzmark, abdominal ultrasound, abdominal CT, Cine-MRI, endoscopic findings, etc.)
-Pathological findings
-Stool metabolome analysis, organic acid analysis
-Bile metabolome analysis
-Urinary metabolome analysis
-Clinical findings, history, complications, and medication history
-Questionnaire/Questionnaire
-Fecal microbiota analysis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age: 20 years old or older
Gender: any gender
Subjects: Patients with unexplained abdominal symptoms and patients without abdominal symptoms
Key exclusion criteria
Patients who cannot give their consent to participate in this study. Patients who are unable to collect specimens due to defecation problems.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university of health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
takaomi0027@gmail.com
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
2868520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
Homepage URL
takaomi0027@gmail.com
Sponsor or person
Institute
International university of health and welfare Narita hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Dental College Yokohama Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International university health and welfare Narita hospital
Address
852, Hatakeda, Narita, Chiba
Tel
0476355600
takaomi0027@gmail.com
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
主機関：国際医療福祉大学成田病院
分担施設：神奈川歯科大学附属横浜クリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 07 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058898
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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