UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000050924
Receipt number	R000058046
Scientific Title	A confirmation study of changes short-chain fatty acid content and intestinal regulation test in stool of Bifidobacterium strain GCL2505 and inulin -Placebo-controlled randomized double-blind crossover study-
Date of disclosure of the study information	2024/07/02
Last modified on	2023/04/25 15:15:30

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Basic information

Public title

A confirmation study of changes short-chain fatty acid content and intestinal regulation test in stool of synbiotics intake

Acronym

A confirmation study of changes short-chain fatty acid content and intestinal regulation test in stool of synbiotics intake

Scientific Title

A confirmation study of changes short-chain fatty acid content and intestinal regulation test in stool of Bifidobacterium strain GCL2505 and inulin
-Placebo-controlled randomized double-blind crossover study-

Scientific Title:Acronym

A confirmation study of changes short-chain fatty acid content and intestinal regulation test in stool of synbiotics intake

Region

Japan

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To confirm the effects of ingestion of bifidobacteria and inulin on stool short-chain fatty acid content

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Short-chain fatty acid content in faeces (acetic acid, propionic acid, n-butyric acid) during intake period I and intake period II.

Key secondary outcomes

･Short-chain fatty acid content in faeces (lactic acid, succinic acid, formic acid, iso-butyric acid, iso-valeric acid, n-valeric acid)
･Short-chain fatty acid content in faeces (acetic acid, propionic acid, n-butyric acid) during the pre-observation period and the resting period.
･Bifidobacterium count in faeces (measured by qPCR)
･Amount of defecation, frequency of defecation, BSS (Bristol stool scale(Stool consistency))

Base

Study type

Interventional

Study design

Basic design

Cross-over

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

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

100g beverage containing bifidobacterium GCL2505 (1.10^10 CFU/mL) and inulin (2g) (once a day for 2 weeks)

Interventions/Control_2

100g placebo beverage containing neither bifidobacterium GCL2505 nor inulin (once a day for 2 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)Japanese males and females aged of 20-64 years at the date of informed consent
2) Subjects who have stable bowel movements (usually, those who have a faeces movement more than 5 days a week)
3)Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study

Key exclusion criteria

1) Subjects who have a history of serious kidney disease, heart disease, respiratory disease, endocrine disease, diabetes, etc., those who are suffering from it, and those who are undergoing treatment (excluding transient treatment such as colds)
2) Subjects who have chronic diseases and regularly use medicines
3) Subjects who have digestive diseases that affect digestion and absorption or defecation, or have a history of surgery (excluding appendicitis)
4)Subjects who has a current or history of drug dependence and/or alcoholism
5) Subjects who regularly use medicines that affect the intestinal environment, especially laxatives, antiflatulents, and laxatives that affect bowel movements
6) Subjects who are taking antibiotics or antibacterial agents, or Subjects who have taken them within 1 month before the screening test
7) Subjects who regularly use health foods that are known to improve constipation at the time of screening
8) Subjects who cannot follow the restrictions on foods that may affect the intestinal environment during the study period.
9) Subjects who have declared that they have allergies to foods or medicines
10) Subjects who consistently consumes more than the appropriate amount of alcohol (approximately 40 g of pure alcohol per day, for example, 2 medium-sized bottles of beer, 1,000 mL)
11) Subjects who have a excessive smoking habit (more than 21 cigarettes/day)
12) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
13) Subjects who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past three months from the date of consent, or who plan to participate in others
14) Subjects who are judged unsuitable for this study by principal investigator

Target sample size

120

Research contact person

Name of lead principal investigator

1st name Daisuke

Middle name

Last name Tsuge

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Doctor

Zip code

108-0075

Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

TEL

03-3452-3382

Email

shibaura@sempos.or.jp

Public contact

Name of contact person

1st name Eiji

Middle name

Last name Yoshikawa

Organization

KSO Corporation

Division name

Clinical Trial Management department

Zip code

105-0023

Address

1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name

Funding Source

Organization

Ezaki Glico Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17Joutou-machi,Maebashi-shi,Gunma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2024 Year 07 Month 02 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

Preinitiation

Date of protocol fixation

2023 Year 03 Month 24 Day

Date of IRB

2023 Year 03 Month 24 Day

Anticipated trial start date

2023 Year 04 Month 28 Day

Last follow-up date

2023 Year 08 Month 02 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2023 Year 04 Month 25 Day

Last modified on

2023 Year 04 Month 25 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058046