![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000034021 |
Receipt No. | R000038709 |
Scientific Title | The relationship between pathogenesis of irritable bowel syndrome and microbiome |
Date of disclosure of the study information | 2018/09/13 |
Last modified on | 2018/09/13 |
Basic information | ||
Public title | The relationship between pathogenesis of irritable bowel syndrome and microbiome | |
Acronym | irritable bowel syndrome and microbiome | |
Scientific Title | The relationship between pathogenesis of irritable bowel syndrome and microbiome | |
Scientific Title:Acronym | irritable bowel syndrome and microbiome | |
Region |
|
Condition | ||
Condition | irritable bowel syndrome | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To compare microbiome between patients with irritable bowel syndrome and healthy controls. To investigate relationships between microbiome and symptoms or QOL scores of patients with IBS. |
Basic objectives2 | Others |
Basic objectives -Others | To compare prevalence of food hypersensitibity or serum cytokine profile between patients with irritable bowel syndrome and healthy controls. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Diversity of microbiome |
Key secondary outcomes | Prevalence of food hypersensitivity.
Serum cytokine profile |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients with irritable bowel syndrome. Healthy controls. | |||
Key exclusion criteria | Patients with systemic inflanmatoris disease. Patients with malignant disorders. | |||
Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Kawasaki Medical School | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | 577 Matsusima, Kurashiki city, Okayama, Japan | ||||||
TEL | 086-462-1111 | ||||||
shiotani@med.kawasaki-m.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Kawasaki Medical School | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | 577 Matsusima, Kurashiki city, Okayama, Japan | ||||||
TEL | 086-462-1111 | ||||||
Homepage URL | |||||||
shiotani@med.kawasaki-m.ac.jp |
Sponsor | |
Institute | Kawasaki Medical School |
Institute | |
Department |
Funding Source | |
Organization | Self sustaining |
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 | |
Address | |
Tel | |
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 | 川崎医科大学附属病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038709 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |