UMIN-ICDS Clinical Trial

Public title

Study to Evaluate the Effects of Consuming a Food Containing Fermented Rice Bran on Bowel Movements
--Open-Label Pre- and Post-Consumption Comparison Study--

Acronym

Study to Evaluate the Effects of Consuming a Food Containing Fermented Rice Bran on Bowel Movements

Scientific Title

Study to Evaluate the Effects of Consuming a Food Containing Fermented Rice Bran on Bowel Movements
--Open-Label Pre- and Post-Consumption Comparison Study--

Scientific Title:Acronym

Study to Evaluate the Effects of Consuming a Food Containing Fermented Rice Bran on Bowel Movements

Region

Japan

Condition

No

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the effect on improving bowel movements under adjusted study conditions based on the results of the previous study (UMIN Trial ID: UMIN000060916), in participants who participated in the previous study.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Number of bowel movements recorded in the bowel movement diary

Key secondary outcomes

*Secondary Evaluation Items
1) Number of bowel movements days per week, stool volume, stool consistency, stool odor, sensation of incomplete evacuation, sense of relief, pain, straining (as recorded in bowel movement diary)

*Safety Assessment
1) Physician Consultation/Assessment of Adverse Events and Side Effects
2) Daily Activity Log

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

Intake of the active food (1 cupsule per day for 4 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Individuals who participated in the previous study (UMIN Trial ID: UMIN000060916) and who provided voluntary consent to the secondary use of data obtained from the previous study in the present study.
2) Healthy men and women aged 20 years or older but under 65 years at the time of obtaining consent to participate in the study.
3) Healthy individuals without chronic physical conditions, including skin diseases.
4) Individuals experiencing mild constipation with relatively hard stool consistency.
5) Individuals with spontaneous bowel movements approximately 3 to 5 times per week.
6) Individuals who have received sufficient explanation regarding the purpose and content of this study, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this study.
7) Individuals who can attend the designated examination date and undergo the examination.
8) Individuals deemed suitable for participation in this study by the principal investigator.

Key exclusion criteria

Individuals
1) currently suffering from any disease and undergoing pharmacological treatment.
2) with a history or current presence of hemorrhoids, chronic fatigue syndrome, mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
3) with a history or current condition of serious liver, kidney, heart, lung, blood, brain, or gastrointestinal disorders.
4) diagnosed with irritable bowel syndrome or inflammatory bowel disease.
5) who have taken or applied medication for disease treatment within the past month.
6) who habitually take laxatives, intestinal regulators, or similar medications.
7) under treatment for functional constipation or similar conditions.
8) diagnosed with chronic constipation under the 2023 Diagnostic Guidelines for Bowel Dysfunction.
9) with severe anemia.
10) with a BMI of 30.0 kg/m2 or higher.
11) with allergies to test food components, other foods, or medications.
12) whose use of bowel-improving foods or supplements has changed or may change during the study.
13) who used functional foods containing rice bran fermented within the past 3 months.
14) with irregular eating habits or a tendency toward an unbalanced diet
15) whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women.
16) with regular exercise habit (>=30 minutes per session, at least twice per week).
17) with smoking habits.
18) who may need allergy medication during the study.
19) with irregular lifestyles, such as shift work or night work.
20) who may alter their lifestyle habits during the study period.
21) who donated 200 mL within 1 month or 400 mL within 3 months before the study.
22) in another clinical study or within 3 months of one.
23) pregnant, breastfeeding, or planning pregnancy during the study.
24) otherwise deemed ineligible for this study by the principal investigator.

Target sample size

20

Name of lead principal investigator

1st name	Takashi
Middle name
Last name	Tagawa

Organization

Maruzen Pharmaceuticals Co., Ltd.

Division name

Research & Development Division

Zip code

729-3102

Address

1089-8, Shinichi-cho Sagata, Fukuyama, Hiroshima

TEL

0847-52-5501

Email

t-tagawa@maruzenpcy.co.jp

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Maruzen Pharmaceuticals Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.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

2026

Year

11

Month

03

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

Preinitiation

Date of protocol fixation

2026

Year

10

Month

07

Day

Date of IRB

2026

Year

10

Month

08

Day

Anticipated trial start date

2026

Year

11

Month

04

Day

Last follow-up date

2026

Year

12

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

11

Month

02

Day

Last modified on

2026

Year

10

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072406