Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060840) titled 'A study to examine how inulin intake affects gut microbiota and immune responses in people with oral lichen planus' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Kyushu University

Condition: Condition - Oral lichen planus Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069616

Disclaimer: Curated by HT Syndication.