Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062676) titled 'Perioperative oral care with L8020-containing dentifrice gel and mouthwash in patients undergoing gastrectomy for gastric cancer' on Aug. 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Minoh City Hospital

Condition: Condition - Gastric cancer scheduled for curative gastrectomy Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether perioperative oral care using a dentifrice gel and mouthwash containing Lactobacillus rhamnosus L8020 improves oral inflammation in patients undergoing curative gastrectomy for gastric cancer. The study also explores changes in periodontal pathogen-derived enzyme activity, postoperative complications, systemic inflammation, oral and gut microbiomes, nutritional and body composition parameters, and postoperative prognosis. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants use a dentifrice gel (Medicinal L8020 Lacresh Dental Gel [DJ]) and mouthwash (Lacresh NW; JEX CO., LTD.) containing Lactobacillus rhamnosus L8020 from enrollment until one month after surgery. Participants perform toothbrushing for at least two minutes followed by mouth rinsing three times daily, after breakfast, lunch, and dinner. Dentures are cleaned using the same dentifrice gel. Standard perioperative oral care is provided concomitantly as clinically indicated.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with gastric cancer scheduled to undergo curative gastrectomy, including distal gastrectomy, proximal gastrectomy, or total gastrectomy

2. Patients who are able to perform oral hygiene and toothbrushing independently or with assistance

3. Patients who provide written informed consent to participate in the study Key exclusion criteria - 1. Patients who have received prolonged antibiotic therapy or consumed a large amount of probiotics within one month before enrollment

2. Patients undergoing emergency treatment for a severe odontogenic infection

3. Patients with severe immunodeficiency

4. Patients with known hypersensitivity to products containing L8020

5. Patients with severe cognitive impairment that would interfere with participation in the study

6. Patients considered unsuitable for participation by the principal investigator Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 12 Month 24 Day Date of IRB - 2026 Year 01 Month 05 Day Anticipated trial start date - 2026 Year 05 Month 18 Day Last follow-up date - 2034 Year 01 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071750

Disclaimer: Curated by HT Syndication.