UMIN-ICDS Clinical Trial

Public title

Perioperative oral care with L8020-containing dentifrice gel and mouthwash in patients undergoing gastrectomy for gastric cancer

Acronym

Gastric Cancer L8020 Oral Care Study

Scientific Title

Effect of oral intervention with Lactobacillus rhamnosus L8020-containing dentifrice gel and mouthwash on systemic inflammation, nutritional status, and prognosis during the perioperative period of gastric cancer: a prospective single-center study

Scientific Title:Acronym

Gastric Cancer L8020 Perioperative Oral Care Study

Region

Japan

Condition

Gastric cancer scheduled for curative gastrectomy

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Change in the PMA index from enrollment to one month after surgery.
The PMA index is assessed at enrollment, immediately before surgery, and one month after surgery.

Key secondary outcomes

1. Longitudinal changes in periodontal pathogen-derived enzyme activity assessed using ADCHECK

2. Postoperative pneumonia, surgical site infection (SSI), and length of hospital stay

3. Longitudinal changes in systemic inflammation assessed by IL-6

4. Longitudinal changes in the salivary and gut microbiomes

5. Longitudinal changes in nutritional parameters including the prognostic nutritional index (PNI) and transthyretin

6. Longitudinal changes in body composition

7. Longitudinal changes in CT-based psoas muscle index (PMI) and intramuscular adipose tissue content (IMAC)

8. Postoperative complications and adverse events

9. Recurrence-free survival (RFS), overall survival (OS), patterns of recurrence, and treatment after recurrence

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

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.

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

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 sample size

40

Name of lead principal investigator

1st name	Shinya
Middle name
Last name	Urakawa

Organization

Minoh City Hospital

Division name

Department of Surgery

Zip code

562-0014

Address

5-7-1 Kayano, Minoh, Osaka 562-0014, Japan

TEL

072-728-2001

Email

s.urakawa@minoh-hp.jp

Name of contact person

1st name	Shinya
Middle name
Last name	Urakawa

Organization

Minoh City Hospital

Division name

Department of Surgery

Zip code

562-0014

Address

5-7-1 Kayano, Minoh, Osaka 562-0014, Japan

TEL

072-728-2001

Homepage URL

Email

s.urakawa@minoh-hp.jp

Institute

Minoh City Hospital

Institute

Department

Personal name

Shinya Urakawa

Organization

Minoh City Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

JEX CO., LTD.: Provides the Medicinal Lacresh DJ and Lacresh NW free of charge for research purposes.
ADTEC Co., Ltd.: Provides ADCHECK measurements free of charge as research support.

Organization

Ethics Committee of Minoh City Hospital

Address

5-7-1 Kayano, Minoh, Osaka 562-0014, Japan

Tel

072-728-2001

Email

minoh-rinsyokenkyu@kyowakai.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

箕面市立病院

Date of disclosure of the study information

2026

Year

08

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study was initiated after approval by the Ethics Committee of Minoh City Hospital and permission from the head of the institution; however, registration in UMIN-CTR was performed after initiation of participant enrollment. Eight participants had been enrolled before UMIN-CTR registration, and these participants will be included in the analyses according to the study protocol.
This is a prospective, single-center, single-arm interventional study. The primary analysis is a within-participant comparison of the PMA index at enrollment, immediately before surgery, and one month after surgery. As an exploratory analysis, patients who received standard perioperative oral care immediately before the study period will be used as a retrospective reference group, with propensity-score matching planned for comparison.

Registered date

2026

Year

08

Month

25

Day

Last modified on

2026

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071750