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A study to examine how inulin intake affects gut microbiota and immune responses in people with oral lichen planus

Randomized, double-blind, placebo-controlled study evaluating the effects of inulin supplementation on gut microbiota and immune parameters in patients with oral lichen planus - INULIN-OLP Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060840
Enrollment
80
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral lichen planus

Interventions

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 dinn

Sponsors

Kyushu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactNaoki Kaneko

Kyushu University Section of Oral and Maxillofacial Surgery, Division of Maxillofacial Diagnostic and Surgical Science

kaneko@dent.kyushu-u.ac.jp092-642-6447

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026