UMIN-ICDS Clinical Trial

Public title

A study on breath-hydrogen concentrations and abdominal symptoms after ingesting the carbohydrate solution in adult males

Acronym

A study on breath-hydrogen concentrations and abdominal symptoms after ingesting the carbohydrate solution

Scientific Title

An exploratory study on relationship between abdominal symptoms and breath-hydrogen concentrations after ingesting the carbohydrate solution in adult males - an open-label trial -

Scientific Title:Acronym

An exploratory study on relationship between abdominal symptoms and breath-hydrogen concentrations after ingesting the carbohydrate solution in adult males

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

One of the aims of this study is to confirm the increase of breath-hydrogen concentration after ingesting a carbohydrate solution (glucose or lactulose) with subjects who often suffer a bloating after meal. The factors affecting inter-day differences of the breath-hydrogen concentration profiles after ingesting the carbohydrate solutions are also explored.

Basic objectives2

Others

Basic objectives -Others

Fact finding

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

･ Breath-hydrogen concentrations after ingesting the carbohydrate solution.
･ Abdominal symptoms

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Only water is available to take for all subjects from awaken to ingesting a carbohydrate solution at 9:00 AM. Subjects take prescribed diets for 3 meals in the previous day.
The same interventions are repeated 3 times (4 times in total) for every 2 weeks. Glucose solution is used for 1st to 3rd intervention, and lactulose solution is used for 4th intervention, as the carbohydrate solution.

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

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male

Key inclusion criteria

1. Those who made the written agreement on participation in the trial
2. Japanese males who are aged between 20 and 60 years at the time of informed consent
3. Those who often suffer bloating after meals
4. Those who can follow the schedules and manuals ordered by the research director

Key exclusion criteria

1. Those who have ingested antibiotics within 4 weeks
2. Those who will have ingested laxative or gastrointestinal agent during the study period
3. Under treatment for diabetes
4. Fasting blood glucose 126 mg/dL or more
5. HbA1c 6.1 or more
6. Those who are judged to be ineligible for this study by the physician, based on the laboratory values and vital signs
7. Those who currently have or have history of severe disorders on digestive organ, liver, kidney, heart, lung, urinary tract, genital tract, or blood, and, consequently, judged to be ineligible for this study by the physician
8. Those who have utilized the pharmaceutical agent within 1 month, and consequently, judged to be ineligible for this study by the physician
9. Those who are judged to be inappropriate for this study by the physician

Target sample size

50

Name of lead principal investigator

1st name	Mamoru
Middle name
Last name	Oki

Organization

Seisyukai Clinic, Seishukai Medical corporation

Division name

Hospital director

Zip code

111-0036

Address

matsugatani 3-18-5, Taito-ku, Tokyo

TEL

03-5827-0930

Email

clinical-trial@imemqrd.co.jp

Name of contact person

1st name	Yoshitada
Middle name
Last name	Hira

Organization

IMEQRD Co., Ltd

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL

Email

t-ishida@imeqrd.co.jp

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjuku-ku,Tokyo

Tel

03-6704-5968

Email

n-yuzawa@imeqrd.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

07

Month

26

Day

Date of IRB

2022

Year

07

Month

26

Day

Anticipated trial start date

2022

Year

09

Month

09

Day

Last follow-up date

2022

Year

10

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

08

Month

08

Day

Last modified on

2023

Year

01

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055303