UMIN-CTR Clinical Trial

Basic information
Public title	The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Acronym	The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Scientific Title	The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Scientific Title:Acronym	The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Region	Japan

Condition
Condition	Functional gastrointestinal disorders
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will prospectively observe the symptoms of irritable bowel syndrome under stress and examine the effects of probiotic-containing foods on improving or preventing the onset of irritable bowel syndrome.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in Izumo scale between lactic acid bacteria group and placebo group
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Levilactobacillus namurensis (Ln) ME-686 Lactobacillus-containing foods should be ingested 3 times a day for 2 months from the start of the training.
Interventions/Control_2	Levilactobacillus namurensis (Ln) ME-686-free dairy products should be taken 3 times a day for 2 months from the start of the training.
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	25 years-old >=
Gender	Female
Key inclusion criteria	Female National Defense Medical College Self-Defense Forces Candidate Nursing Student Third Grade
Key exclusion criteria	1. Persons with mental illness (judged from medical history) 2. Those who are allergic to milk or lactic acid bacteria 3. Persons with a history of surgery due to intestinal disease 4. Those who cannot obtain consent
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Hokari
Organization	National Defense Medical College
Division name	Internal medicine 2
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa City, Saitama Prefecture
TEL	04-2995-1511
Email	ryota@ndmc.ac.jp

Public contact
Name of contact person	1st name Suguru Middle name Last name Ito
Organization	National Defense Medical College
Division name	Internal medicine 2
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa City, Saitama Prefecture
TEL	04-2995-1511
Homepage URL
Email	doc32004@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Defense Medical College Ethics Committee
Address	3-2 Namiki, Tokorozawa City, Saitama Prefecture
Tel	04-2995-1511
Email	ins010@ndmc.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	2021 Year 04 Month 23 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	47
Results	Analysis in progress.
Results date posted	2021 Year 10 Month 25 Day
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	2020 Year 11 Month 16 Day
Date of IRB	2020 Year 11 Month 16 Day
Anticipated trial start date	2021 Year 05 Month 06 Day
Last follow-up date	2021 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 23 Day
Last modified on	2021 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050272