UMIN-CTR Clinical Trial
| Recruitment status | Open public recruiting |
| Unique ID issued by UMIN | UMIN000028693 |
| Receipt No. | R000032843 |
| Scientific Title | Impact of Impaired barrier function in duodenal mucosa to functional dyspepsia: discovering the pathophysiology and developing new therapeutic strategy |
| Date of disclosure of the study information | 2017/08/16 |
| Last modified on | 2019/08/20 (Ver. 5) |
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| Basic information | ||
| Public title | Impact of Impaired barrier function in duodenal mucosa to functional dyspepsia: discovering the pathophysiology and developing new therapeutic strategy | |
| Acronym | Impaired barrier function in duodenum causes functional dyspepsia (FD) | |
| Scientific Title | Impact of Impaired barrier function in duodenal mucosa to functional dyspepsia: discovering the pathophysiology and developing new therapeutic strategy | |
| Scientific Title:Acronym | Impaired barrier function in duodenum causes functional dyspepsia (FD) | |
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| Condition | ||
| Condition | functional dyspepsia (FD) | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To clarify the mechanism of functional dyspepsia, focusing duodenal mucosal barrier function |
| Basic objectives2 | Others |
| Basic objectives -Others | pathophysiology |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Explanatory |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | Comparison of difference in duodenal barrier function between FD patients and healthy volunteer |
| Key secondary outcomes | Comparison of the difference in duodenal barrier function among FD with or without non erosive reflux disease (NERD) and healthy volunteer |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Placebo |
| Stratification | NO |
| Dynamic allocation | NO |
| Institution consideration | |
| Blocking | NO |
| Concealment | No need to know |
| Intervention | ||
| No. of arms | 3 | |
| Purpose of intervention | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | measuring duodenal barrier function in FD patients, using mini ussing chamber system, and is compared to that in healthy volunteer. | |
| Interventions/Control_2 | mRNA is extracted from duodenal tissue, which is used for gene expression analysis in tight junctinal proteins and its regulatory factors. | |
| Interventions/Control_3 | Duodenal histological changes are evaluated with microscopical analysis. Protein expression is measured with immnohistochemical method. | |
| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | FD patients
1. 30 FD patients (Male/Female=1:1) who matches Rome IV criteria. 2. Performance status (PS) 0 3. age; 20 to 85 y 4. term; from 2017.9 to 2020 12 5. Informed consent was obtained Healthy volunteer 1. no medication, no symptom 2. PS0 3. age; from 20 to 69 y 4. Informed consent was obtained |
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| Key exclusion criteria | Only healthy volunteer
1. medication such as acid suppressive drug, Nsaids, steroids or immune suppressive drug 1 month prior to the study All participants 1. past history of or scheduled abdominal surgery 2. forbidden in endoscopic examination (e.g. coagulation disorder) 3. pregnancy 4. severe healthy status 5. psychological disorder 6. those who are judged inappropriate to entry the study |
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| Target sample size | 40 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Tohoku University Graduate School of Medicine | ||||||
| Division name | Division of Gastroenterology | ||||||
| Zip code | 980-8574 | ||||||
| Address | 1-1 Seiryomach Aobaku Sendai MIyagi, 980-8574 | ||||||
| TEL | 022-717-7171 | ||||||
| tkoike@rd5.so-net.ne.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Tohoku University Graduate School of Medicine | ||||||
| Division name | Division of Gastroenterology | ||||||
| Zip code | 980-8574 | ||||||
| Address | 1-1 Seiryomach Aobaku Sendai MIyagi, 980-8574 | ||||||
| TEL | 022-717-7171 | ||||||
| Homepage URL | http://www.rinri.med.tohoku.ac.jp/portal | ||||||
| takaxeve2004@aurora.ocn.ne.jp | |||||||
| Sponsor | |
| Institute | Division of Gastroenterology
Tohoku University Graduate School of Medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Division of Gastroenterology
Tohoku University Graduate School of Medicine |
| 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 | Tohoku University Graduate School of Medicine |
| Address | 1-1 Seiryomach Aobaku Sendai Miyagi |
| Tel | 022-717-7171 |
| takaxeve2004@aurora.ocn.ne.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 | 東北大学大学院消化器病態学分野 |
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| Date of disclosure of the study information |
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| 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 | TEER in duodenal epithelium was decreased more than that in healthy volunteer against weaky acid stimulation. |
| Results date posted | |
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| Date of the first journal publication of results | |
| Baseline Characteristics | |
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| Plan to share IPD | |
| IPD sharing Plan description | |
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| Recruitment status | Open public recruiting | ||||||
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| Date analysis concluded |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032843 |
