UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028726 |
|---|---|
| Receipt number | 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 11:49:44 |
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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
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
kenkyu-shinsei@ml.cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032873
