Study of intestinal flora and adverse events at the time of eradication of H. pylori

Study of intestinal flora and adverse events at the time of eradication of H. pylori - Study of intestinal flora and adverse events at the time of eradication of H. pylori

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028726

Enrollment

Registered

2017-08-18

Start date

2017-08-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori

Interventions

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 exclu

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactShinya Kimura

Saga University Hospital Clinical Research Center

kenkyu-shinsei@ml.cc.saga-u.ac.jp0952343400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026