UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062366 |
|---|---|
| Receipt number | R000071376 |
| Scientific Title | A before-and-after interventional study of the effects of consuming a beverage containing wheat fermentation extract on the gut microbiota of healthy adults and adults with mild chronic symptoms |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/28 15:20:06 |
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Basic information
Public title
A study to investigate the effects of a beverage containing wheat fermentation extract on the balance of gut microbiota
Acronym
Wheat Fermentation Extract Beverage and Gut Microbiota Study
Scientific Title
A before-and-after interventional study of the effects of consuming a beverage containing wheat fermentation extract on the gut microbiota of healthy adults and adults with mild chronic symptoms
Scientific Title:Acronym
Wheat Fermentation Extract Gut Microbiota Before-and-After Study
Region
| Japan |
Condition
Condition
Healthy adults and adults with mild chronic symptoms that do not substantially interfere with daily life
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 12-week consumption of a beverage containing wheat fermentation extract, whose main functional component is lipopolysaccharide (LPS), on the gut microbiota of healthy adults and adults with mild chronic symptoms who are not receiving regular medical treatment.
Basic objectives2
Others
Basic objectives -Others
Biological effects on the composition and diversity of gut microbiota
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to week 12 in the diversity and taxonomic composition of gut microbiota assessed by 16S rRNA gene amplicon sequencing of fecal samples.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants consume the beverage containing wheat fermentation extract for 12 weeks. Two sachets are taken twice daily, on an empty stomach after waking and before bedtime (four sachets/day). Each 16.5-mL sachet contains 600 ug of LPSp, corresponding to 2,400 ug of LPSp per day.
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Adults aged 20 years or older and younger than 80 years at the time of consent.
2) Healthy adults or adults with mild chronic subjective symptoms-such as fatigue, altered bowel habits, cold sensitivity, mild sleep disturbance, mild skin symptoms, or shoulder stiffness-that do not substantially limit daily life, work, or household activities.
3) Individuals not currently receiving regular medical treatment.
4) Individuals who receive an explanation of the study, understand its contents, and provide written informed consent.
5) Individuals considered eligible by the principal investigator and study physician based on the questionnaire, medical history, medication use, and symptom severity.
Key exclusion criteria
1) Pregnant or breastfeeding women.
2) Smokers.
3) Individuals who consumed a beverage containing wheat fermentation extract within 6 months before study initiation.
4) Individuals participating in or planning to participate in another clinical trial.
5) Individuals receiving regular medical treatment, whose symptoms are worsening, who have acute symptoms, or who are considered to require medical management.
6) Individuals suspected of small intestinal bacterial overgrowth (SIBO), based on severe abdominal bloating, chronic abdominal symptoms, or worsening symptoms after fermented foods, and judged ineligible by the principal investigator or study physician.
7) Any other individuals judged unsuitable for participation by the principal investigator or study physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Oda |
Organization
Control of Innate Immunity Collaborative Innovation Partnership
Division name
Research and development
Zip code
761-0301
Address
Bio Research Laboratory, 3rd Floor, FROM Kagawa, 2217-16 Hayashi-cho, Takamatsu City, Kagawa
TEL
087-813-9201
mstkoda@shizenmeneki.org
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nakamoto |
Organization
Control of Innate Immunity Collaborative Innovation Partnership
Division name
Secretariat
Zip code
761-0301
Address
Bio Research Laboratory, 3rd Floor, FROM Kagawa, 2217-16 Hayashi-cho, Takamatsu City, Kagawa
TEL
087-813-9201
Homepage URL
ciitra@shizenmeneki.org
Sponsor or person
Institute
Control of Innate Immunity Collaborative Innovation Partnership
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee,Innate Immune Network
Address
Bio Research Laboratory, 3rd Floor, FROM Kagawa, 2217-16 Hayashi-cho, Takamatsu City, Kagawa
Tel
087-813-9201
npolsinlsin@lsin.org
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
| 2026 | Year | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071376
