UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019998
Receipt number R000023088
Scientific Title Change of microbiota of oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan
Date of disclosure of the study information 2015/12/15
Last modified on 2021/05/09 11:55:17

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Basic information

Public title

Change of microbiota of oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan

Acronym

Change of microbiota by lansoprazole and vonoprazan

Scientific Title

Change of microbiota of oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan

Scientific Title:Acronym

Change of microbiota by lansoprazole and vonoprazan

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Medicine in general Gastroenterology Infectious disease
Geriatrics

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To clarify changes of microbiota in oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Changes of microbiota in oral cavity, stomach and intestine between before and after administration of lansoprazole and vonoprazan

Key secondary outcomes

(1) Change of serum gastrin level


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants 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

1. Lansoprazole 30mg once daily dosing 28 days
2. Washout periods: 28 days
3. Vonoprazan 20mg once daily dosing 28 days

Interventions/Control_2

1. Vonoprazan 20mg once daily dosing 28 days
2. Washout periods: 28 days
3. Lansoprazole 30mg once daily dosing 28 days

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

20 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Healthy volunteers at age of 20-50 years old with informed consent
2. Performance status: 0
3. H. pylori-negative
4. CYP2C19 genotype: poor metabolizer and rapid metabolizer

Key exclusion criteria

1. With medication of anti-microbial agents within three months.
2. With medication of anti-gastric acid inhibitory drug within three months.
3. With malignant diseases and severe complications
4. With mediaction of drug in relation with CYP3A4 pathway
5. With medication of corticosteroid
6. With active peptic ulcer
7. With severe complication, such as heart failure, renal failure and respiratory failure
8. With allergy for lansoprazole or vonoprazan
9. H. pylori-positive patients
10. Pregnancy
11. No informed consent

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Andoh

Organization

Shiga University of Medical Science

Division name

Division of Gastroenterology

Zip code


Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2217

Email

hqmed2@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsushige Sugimoto

Organization

Shiga University of Medical Science Hospital

Division name

Division of Digestive Endoscopy

Zip code


Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2618

Homepage URL


Email

sugimo@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science Hospital

Institute

Department

Personal name



Funding Source

Organization

Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 12 Month 15 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


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

2015 Year 12 Month 01 Day

Date of IRB

2015 Year 12 Month 01 Day

Anticipated trial start date

2015 Year 12 Month 15 Day

Last follow-up date

2020 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 30 Day

Last modified on

2021 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023088


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name