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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028726
Receipt No. R000032873
Scientific Title Study of intestinal flora and adverse events at the time of eradication of H. pylori
Date of disclosure of the study information 2017/08/18
Last modified on 2019/08/24

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Basic information
Public title Study of intestinal flora and adverse events at the time of eradication of H. pylori
Acronym Study of intestinal flora and adverse events at the time of eradication of H. pylori
Scientific Title Study of intestinal flora and adverse events at the time of eradication of H. pylori
Scientific Title:Acronym Study of intestinal flora and adverse events at the time of eradication of H. pylori
Region
Japan

Condition
Condition Helicobacter pylori
Classification by specialty
Gastroenterology Adult Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Examination of the effect of intestinal agent on intestinal flora (faecal microbial flora) and reduction of side reaction (diarrhea) during eradication treatment of young H. pylori infected person
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of intestinal bacterial flora

Regarding intestinal flora, the base sequence (read data) of 16S rRNA gene derived from intestinal bacteria obtained by analysis with NGS is grouped (OTU classification) according to the similarity (96 to 97%) , A relative proportion of the microflora composition of each specimen is calculated by performing phylogenetic identification for each OTU. A comparison is made between the groups on this microflora configuration. As a comparison method, the similarity of each flora is examined by comparing beta-diversity (UniFrac analysis and HeatMap cluster analysis) and alfa-diversity comparison (OTU number, chao 1, PD whole tree, Shannon index). In addition, we compare the ratio of the bacterial group constituting the flora and the average number / median value.
Key secondary outcomes Compare the presence and absence of side reactions and the extent of side reactions between the groups in the group treated with H. pylori eradication therapist combined with or without biofermin R combination.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 H. pylori infected individuals are randomly divided into two groups, one treated with H. pylori by disinfectant plus Biofermin R (biofermin R combination group), while the other one is H. pylori excluded only by bacteriocide treatment (biofermin R non-combined group). In both groups, each stool is collected before sterilization treatment, from day 7 to day 8 of eradication treatment, and before decontamination judgment, flora analysis is performed using next generation sequencer (NGS).
Interventions/Control_2 In both groups, the appearance and alleviation effect of side reactions associated with eradication treatment are judged.
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
15 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Those who were positive for H. pylori antibody test in urine and positive for H. pylori antigen in feces, agreed with the implementation of H. pylori eradication treatment, and received a research institution of this study
Key exclusion criteria 1. Persons who were unable to obtain consent from the person or guardian
2. Person who is responsible for research, and who is in the hospital, judged that the attending physician has problems in participation
3. Those who have already taken H. pylori eradication treatment
4. Exclude from H. pylori eradication therapy
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Muneaki
Middle name
Last name Matsuo
Organization Saga University Hospital
Division name Pediatrics
Zip code 849-8501
Address 5-1-1 Nabeshima saga-City 849-8501 Japan
TEL 0952342314
Email matsuo@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Kimura
Organization Saga University Hospital
Division name Clinical Research Center
Zip code 849-8501
Address 5-1-1 Nabeshima saga-City 849-8501 Japan
TEL 0952343400
Homepage URL
Email kenkyu-shinsei@ml.cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Biofermin Seiyaku Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor 1. Imamura Hospital
2. Yamamoto Memorial Hospital
3. Imari Arita Kyoritsu Hospital
4. Fujioka Hospital
5. Kahan Hospital
6. Ureshino Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Center, Saga University Hospital
Address 5-1-1 Nabeshima saga-City 849-8501 Japan
Tel 0952343400
Email kenkyu-shinsei@ml.cc.saga-u.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
2017 Year 08 Month 18 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 65
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 Completed
Date of protocol fixation
2017 Year 04 Month 28 Day
Date of IRB
2017 Year 08 Month 18 Day
Anticipated trial start date
2017 Year 08 Month 18 Day
Last follow-up date
2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 18 Day
Last modified on
2019 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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