UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000032873