UMIN-CTR Clinical Trial

Public title

The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial (Transitioned to jRCT)

Acronym

Study of antibiotic-resistant lactic acid bacteria cobination eradication therapy for H. pylori infection

Scientific Title

The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial (Transitioned to jRCT)

Scientific Title:Acronym

Study of antibiotic-resistant lactic acid bacteria cobination eradication therapy for H. pylori infection

Region

Japan

Condition

Helicobacter pylori infection

Classification by specialty

Gastroenterology

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To examine the effect of Bifermin R, antibiotic-resistant lactic acid bacteria, on adverse events (mainly diarrhea) of H. pylori eradication therapy and its preventive effect against antibiotics-associated gut microbiota dysbiosis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The occurrence of diarrea during H. pylori eradication therapy (day 0 to day 6) in biofermin R administration group and placebo group.

Key secondary outcomes

1.Gut microflora change (alpha and beta divesity change) at day7, day 14 and pont of judgement after eradication therapy
2.Occurrence of side effect other than diarrhea
3.FSSG scal score before and after therapy
4.Serum diamine oxydase activity before and after therapy
5.Occurence of diarrhea after eradication therapy (between day 7 to day 13)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Individuals who receive primary eradication treatment for H. pylori infection are taken Bioferumin R powder 3 g/day for two weeks from the first day of eradication treatmen.

Interventions/Control_2

Individuals who receive primary eradication treatment for H. pylori infection are taken 3 g/day of potato starch powder for two weeks from the first day of eradication treatmen.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patient who was suspected for H. pylori infection and were positive for H. pylori in one of the following examination, urea breath test, H. pylori stool antigen test, H.pylori antibody test in the urine or in the blood, rapid urease test.
(2) Patient who is expected an beneficial effect after H.pylori radication treatment.
(3) Patients written consent from the person is obtained.
(4) Patients without allergy to the use drugs.

Key exclusion criteria

(1) Patients who have already taken H. pylori eradication therapy before.
(2) Patients who had taken any antibiotics or PPI within 4 weeks before the start day of the study.
(3) Patients under 20 years.
(4) Patients who had taken gastric cancer sugery before (except endoscopic surgery).
(5) Patients with severe renal impairment, serious heart disease, or severe liver disease.
(6) Patients with allergy to the use drugs.
(7) In the cases the test doctor has determined the patient does not fit the study.

Target sample size

76

Name of lead principal investigator

1st name
Middle name
Last name	Eiji Umegaki

Organization

Kobe University Hospital

Division name

Gastroenterology

Zip code

Address

7-5-2 Kusunoki-cho Chuo-ku Kobe-city Japan

TEL

(+81)783825111

Email

eumegaki@med.kobe-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Jun Inoue

Organization

Kobe University Hospital

Division name

Gastroenterology

Zip code

Address

7-5-2 Kusunoki-cho Chuo-ku Kobe-city Japan

TEL

(+81)783825111

Homepage URL

Email

juninoue@med.kobe-u.ac.jp

Institute

Kobe University

Institute

Department

Personal name

Organization

Biofermin Seiyaku Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Terminated

Date of protocol fixation

2017

Year

11

Month

14

Day

Date of IRB

2018

Year

02

Month

26

Day

Anticipated trial start date

2018

Year

02

Month

26

Day

Last follow-up date

2018

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Transitioned to jRCT, jRCTs051180155

Registered date

2017

Year

11

Month

17

Day

Last modified on

2023

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034265