UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of probiotics on the gastric microbiota in functional dyspepsia
Title of the study (Brief title)	Influence of probiotics on the gastric microbiota in functional dyspepsia
Region	Japan

Condition
Condition	Functional dyspepsia
Classification by specialty	Medicine in general Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To target the Functional dyspepsia patients, gastric juice flora and its configuration comprehensively analyzed by gene base sequence measurement methods such as 16SrRNA gene, further clarify the effect of the gastric juice flora of probiotic administration to.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Healthy subjects and FD patients of gastric juice flora and gastric juice flora of probiotic administration after 12 weeks
Key secondary outcomes	FSSG score serum PG1,2 sucrose permeability test

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Lactbacillus gasseri OLL 2716 * 1000000000 CFU content of yogurt is administered one a day for 12 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosis of FD by the RomeIII criteria
Key exclusion criteria	Have proton pump inhibitor administration. After gastrectomy. Have an allergy to lactic acid bacteria formulation. Antimicrobial used within one month. H. pylori-infected persons.
Target sample size	60

Research contact person
Name of lead principal investigator	Yasuhiro Koga
Organization	Tokai University school of Medicine
Division name	Basic Medical Sciences, biological defense science
Address	Isehara, Kanagawa Prefecture Shimokasuya 143
TEL	0463-93-1121
Email	yasuhiro@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Hirohiko Nakae
Organization	Tokai University School of Medicine
Division name	Gastroenterological medicine
Address	Isehara, Kanagawa Prefecture Shimokasuya 143
TEL	0463-93-1121
Homepage URL
Email	nka.1425@gmail.com

Sponsor
Institute	Self funding
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 04 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 03 Month 07 Day
Anticipated trial start date	2014 Year 04 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 22 Day
Last modified on	2016 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024965