UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023739 |
|---|---|
| Receipt number | R000027189 |
| Scientific Title | Distribution of mucosal microbiota: prospective research |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2020/02/28 22:13:59 |
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Basic information
Public title
Distribution of mucosal microbiota: prospective research
Acronym
Distribution of mucosal microbiota: prospective research
Scientific Title
Distribution of mucosal microbiota: prospective research
Scientific Title:Acronym
Distribution of mucosal microbiota: prospective research
Region
| Japan |
Condition
Condition
The patients who are endoscopically normal.
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the distribution of microbiota on the endoscopically normal mucosa of digestive tract from intraoral through proctodeum
Basic objectives2
Others
Basic objectives -Others
Investigation of physiological distribution with microbiota
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Determination of mucosal micorobiota on digestive tract
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
endoscopically normal patients regardless of underlying disease
Key exclusion criteria
Patients with endoscopically visible lesion
Patients taking antibiotics within 4 weeks
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
6028566
Address
465 Kajiicho Hirokoji Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5111
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Uchiyama |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
6028566
Address
465 Kajiicho Hirokoji Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5111
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine Secretariat of Judding Committee
Address
465 Kajiicho Hirokoji Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.f.kpu-m.ac.jp/k/syokanai/
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1159/000496102
Number of participants that the trial has enrolled
17
Results
Collecting mucosa samples by brushing provided sufficient material for mucosa-associated microbiota (MAM) profiling without causing adverse effects. The upper and lower gut MAM profiles differed significantly (p < 0.0001). In the upper and lower gut, the intra- and inter-individual MAM profiles were significantly different (p = 0.0008 and p < 0.0001 respectively).
Results date posted
| 2020 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The volunteers were between 21 and 70 years of age. They had normal mucosa without inflammation or carcinoma.
Moreover, they did not use antibiotics, proton-pump inhibitors (PPIs), probiotics, or other medications that could potentially affect the varieties of gut microbiota during 3 months prior to examination,
Participant flow
Under endoscopic examination, the samples, from the mid-esophagus to the rectum, were collected by the gentle brushing of each anatomical site of the mucosa 7-10 times with Cytology brush (Cook Medical, Bloomington, IN, USA, No. CCB-7-240-3-5). The swab, HydraFlock 6 (Puritan, Guilford, ME, USA, No. 25-3406H), was used for intraoral MAM sampling because it could gently scratch the intraoral mucosa.
Adverse events
None.
Outcome measures
a- and b-Diversity of MAM in gut mucosa samples.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate the distribution of microbiota on the endoscopically normal mucosa of digestive tract (intraoral, esophagus, stomach, duodenum, jejunum, ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum) by 16S rRNA metagenomics using brush sample collection.
Management information
Registered date
| 2016 | Year | 08 | Month | 23 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027189
