Exploratory Study on the Effects of Lactobacillus Consumption on Mental Health

UMIN ID: UMIN000055645

Registered date:27/09/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/09/28
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consumption of the test food (1 bottle a day) for 4 weeks
Consumption of the placebo food (1 bottle a day) for 4 weeks

Outcome(s)

• Primary Outcome: - Bacterial count of each gut microbiota species in feces - Occupancy rate of each gut microbiota species in feces - Salivary chromogranin A and oxytocin - Blood levels of zonulin, LBP, IL-6, TNF-alpha, high-sensitivity CRP, BDNF, L-DOPA, and 5-HTP - Questionnaires Performance-related indicators: WHO-HPQ (short form, Japanese version) Stress-related indicators: State-Trait Anxiety Inventory-Form JYZ (STAI), Brief Job Stress Questionnaire (57-item version), Chalder Fatigue Questionnaire Japanese version, Subjective Vitality Scale Japanese version (SVS-J) Well-being indicators: Cantril's Ladder, Japanese version of the Subjective Happiness Scale (SHS), Interdependent Happiness Scale (IHS) Sleep-related indicators: Pittsburgh Sleep Quality Index Japanese version (PSQI), Oguri-Shirakawa-Azumi Sleep Inventory MA version (OSA-MA) Gastrointestinal-related indicators: Izumo Scale

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 59years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects with a history of gastric or lower gastrointestinal surgery (excluding hemorrhoids and polypectomy). 2. Subjects scheduled to undergo gastric X-ray barium examination or small intestine/colon endoscopy at a clinic, or intestinal cleansing at a clinic or at home between the time of consent and the end of the trials. 3. Subjects planning to take or use medications that may affect the study (such as antibiotics, proton pump inhibitors (PPIs), diabetes medications (e.g., metformin), laxatives (e.g., magnesium oxide), or bile acid sequestrants (e.g., UDCA)) one or more times between the time of consent and the end of the trial. 4. Subjects scoring 50 or above on the Self-Rating Depression Scale (SDS). 5. Subjects with a history or current diagnosis of mental disorders, or those receiving treatment, medication, lifestyle guidance, or counseling for mental disorders. 6. Subjects who have smoking habit. 7. Subjects planning overseas travel, trips longer than one week, or business trips from one week before each intake period to the end of each intake period. 8. Subjects with allergies to food. 9. Females who are pregnant or lactating, and females who could become pregnant during trial period. 10. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: CPCC Company Limited
• Secondary Sponsor: Meiji Co., Ltd.
• Source(s) of Monetary Support: Meiji Holdings Co., Ltd.