UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023739
Receipt No. 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 (Ver. 9)

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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
Email 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
Email k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027189