UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060840 |
|---|---|
| Receipt number | R000069616 |
| Scientific Title | Randomized, double-blind, placebo-controlled study evaluating the effects of inulin supplementation on gut microbiota and immune parameters in patients with oral lichen planus |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/05 22:23:05 |
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Basic information
Public title
A study to examine how inulin intake affects gut microbiota and immune responses in people with oral lichen planus
Acronym
INULIN-OLP Study
Scientific Title
Randomized, double-blind, placebo-controlled study evaluating the effects of inulin supplementation on gut microbiota and immune parameters in patients with oral lichen planus
Scientific Title:Acronym
INULIN-OLP Study
Region
| Japan |
Condition
Condition
Oral lichen planus
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to determine whether inulin supplementation increases the proportion of butyrate-producing bacteria in the gut microbiota of patients with oral lichen planus.
Basic objectives2
Others
Basic objectives -Others
This study aims to clarify the biological effects of inulin supplementation in patients with oral lichen planus by evaluating changes in gut microbiota composition, fecal short-chain fatty acid concentrations, peripheral regulatory T-cell counts, salivary microbiota profiles, and hematological parameters (white blood cell count, eosinophil count, total IgE, and specific IgE). These assessments will help elucidate how inulin influences the gut environment and immune responses in this patient population.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the proportion of butyrate-producing bacteria in the fecal gut microbiota between baseline (before inulin intake) and the end of the 4-week inulin supplementation period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral inulin supplementation. After a 2-week pre-observation period, participants randomized to the inulin group will receive 4 g of inulin per sachet, taken twice daily (e.g., after breakfast and dinner), for a total dose of 8 g/day over 4 consecutive weeks (28 days). Fecal and salivary samples will be collected at baseline, at the end of the 4-week supplementation period, and 1 month after the end of supplementation, and blood samples will be collected at baseline and at the end of the 4-week period.
Interventions/Control_2
Oral placebo supplementation using maltose (Sanmalt Shiro). After a 2-week pre-observation period, participants randomized to the placebo group will receive 4 g of maltose per sachet, taken twice daily (e.g., after breakfast and dinner), for a total dose of 8 g/day over 4 consecutive weeks (28 days). Fecal and salivary samples will be collected at baseline, at the end of the 4-week supplementation period, and 1 month after the end of supplementation, and blood samples will be collected at baseline and at the end of the 4-week period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with oral lichen planus by a dentist
2. Male and female patients aged 18 years or older
3. Individuals who have received sufficient explanation about the study, fully understood its contents, and provided written informed consent of their own free will
Key exclusion criteria
1. Individuals who have used antibiotics within the past 3 months
2. Individuals with a history of hospitalization within the past 3 months
3. Individuals who refuse to participate in this study
4. Pregnant women or women who may be pregnant
5. Individuals with food allergies to inulin or plants of the Asteraceae (Compositae) family, which are the source materials of inulin
6. Any other individuals deemed inappropriate as study participants by the principal investigator
Participants who receive antibiotics during the study period will also be excluded from the analysis.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Moriyama |
Organization
Kyushu University
Division name
Section of Oral and Maxillofacial Surgery, Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-642-6447
moriyama@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Kaneko |
Organization
Kyushu University
Division name
Section of Oral and Maxillofacial Surgery, Division of Maxillofacial Diagnostic and Surgical Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-642-6447
Homepage URL
kaneko@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Clinical Trials Institutional Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069616
