UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048875
Receipt number R000055669
Scientific Title Study on the effect of foods containing inanimate lactic acid bacterium LJ88 on temporary stomach symptoms in adults: Placebo-controlled, randomized, double-blind, parallel-group comparison method
Date of disclosure of the study information 2022/09/09
Last modified on 2023/12/14 11:13:58

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Basic information

Public title

Study on the effect of foods containing inanimate lactic acid bacterium LJ88 on temporary stomach symptoms

Acronym

Effects of lactic acid bacterium LJ88 on the stomach

Scientific Title

Study on the effect of foods containing inanimate lactic acid bacterium LJ88 on temporary stomach symptoms in adults: Placebo-controlled, randomized, double-blind, parallel-group comparison method

Scientific Title:Acronym

Effects of lactic acid bacterium LJ88 on the stomach: an RCT study

Region

Japan


Condition

Condition

Stomach symptoms (non-diseased state)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of foods containing inanimate lactic acid bacterium LJ88 in healthy adults on the efficacy on temporary stomach symptoms and the safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency scale for the symptoms of GERD (FSSG) score after 6 weeks ingestion

Key secondary outcomes

(1) GSRS
(2) Stomach symptom questionnaire (comprehensive impression score by research subjects)
(3) POMS2 shortened version
(4) SF-36v2 Japanese version: Acute version
(5) Serum gastrin concentration


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of food containing inanimate lactic acid bacterium LJ88 about 1 billion cells (6 weeks)

Interventions/Control_2

Oral ingestion of Placebo food (6 weeks)

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Men and women aged between 20 and 64 on the date of obtaining consent
(2) Those who have a FSSG score of 8 points or more
(3) Those who have received a sufficient explanation of the purpose and contents of the research, have the ability to consent, and who have fully understood and voluntarily applied to participate in this research, and consented to participate in this research in writing.

Key exclusion criteria

(1) Those who have a history of Helicobacter pylori infection, or those who are positive for H. pylori antibodies (blood anti-H. pylori antibodies)
(2) Those who regularly use drugs that affect stomach symptoms
(3) Those who are diagnosed with functional dyspepsia according to the ROME IV criteria (specifically, those who have had upper abdominal symptoms that "feel painful" for more than 6 months and have had the above symptoms for the past 3 months)
(4) Those who cannot restrict intake of probiotic foods, prebiotic foods, foods containing lactic acid bacteria and bifidobacteria, and other health foods that are effective in improving gastric symptoms during the study period.
(5) Those who have current medical conditions such as organic diseases of the stomach (gastric ulcer, gastric cancer, gastritis, gastroesophageal reflux disease, etc.)
(6) Those who have experienced food allergies
(7) Those who have frequently become aware of not feeling well due to intake of dairy products.
(8) Those who have a disease requiring urgent treatment or who have serious complications
(9) Those with gastrointestinal diseases that affect digestion and absorption or defecation, or those with a history of surgery
(10) Those who are judged to be unsuitable as research subjects based on the blood test performed in the screening test
(11) Pregnant, intending to become pregnant during the research period, or breast-feeding
(12) Those who are with a history of drug dependence or alcohol dependence or current illness
(13) Those who are participating in research that uses other foods or drugs, or that apply cosmetics or drugs, or those who intend to participate
(14) Others who are judged by the principal investigator to be inappropriate as research subjects

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Yoshitaka
Middle name
Last name Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

103-0001

Address

Kyodo bldg. 201, 13-4 Kodenma-cho, Nihonbashi, Chuo-ku, Tokyo 103-0001, Japan

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name Yasuhiko
Middle name
Last name Komatsu

Organization

Snowden Co., Ltd.

Division name

R&D, Merchandising Div.

Zip code

101-0032

Address

3-7-6 Iwamoto-cho, Chiyoda-ku, Tokyo 101-0032, Japan

TEL

03-3866-2828

Homepage URL


Email

y_komatsu@snowden.co.jp


Sponsor or person

Institute

Nihonbashi Cardiology Clinic

Institute

Department

Personal name



Funding Source

Organization

Snowden Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of Nihonbashi Cardiology Clinic

Address

Kyodo bldg. 201, 13-4 Kodenma-cho, Nihonbashi, Chuo-ku, Tokyo 103-0001, Japan

Tel

03-5641-4133

Email

niho-jimucho@well-sleep.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

医療法人財団健康睡眠会 日本橋循環器科クリニック


Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 09 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

120

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

2020 Year 07 Month 06 Day

Date of IRB

2020 Year 07 Month 08 Day

Anticipated trial start date

2022 Year 09 Month 10 Day

Last follow-up date

2022 Year 12 Month 03 Day

Date of closure to data entry

2023 Year 08 Month 18 Day

Date trial data considered complete

2023 Year 08 Month 22 Day

Date analysis concluded

2023 Year 11 Month 13 Day


Other

Other related information



Management information

Registered date

2022 Year 09 Month 07 Day

Last modified on

2023 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055669


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name