Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060424) titled 'The effect of mouthwash containing agaro-oligosaccharides on the composition and diversity of the oral microbiome' on Jan. 21.

Study Type: Interventional

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

Primary Sponsor: Institute - BIOSIS Lab. Co., Ltd.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study evaluates the effects of using a mouthwash containing agaro-oligosaccharides for two weeks on the oral microbiome in healthy individuals. Furthermore, by evaluating clinical and biochemical parameters as secondary endpoints, we will explore the overall effects on the oral environment Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants gargle with 15 mL of Test Solution A twice daily (after waking up and before bedtime) for at least 30 seconds for a period of 2 weeks. Following a 1-week washout period, they gargle with the other test solution for 2 weeks under the same conditions (15 mL per dose, twice daily, for at least 30 seconds). Interventions/Control_2 - Participants gargle with 15 mL of Test Solution B twice daily (after waking up and before bedtime) for at least 30 seconds for a period of 2 weeks. Following a 1-week washout period, they gargle with the other test solution for 2 weeks under the same conditions (15 mL per dose, twice daily, for at least 30 seconds).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate 2.Persons who are Japanese citizens, aged 20 or older and under 65 at the time of consent Key exclusion criteria - 1.Persons who have systemic diseases (such as severe heart disease, renal disease, or hepatic dysfunction) and are receiving medical treatment, or those with a history of such diseases. 2.Persons who have severe oral diseases (such as stomatitis or advanced dental caries) that are judged by the investigator as likely to affect the study outcomes. 3.Persons who have a history of using antibiotics, steroids, or anti-inflammatory drugs within one week prior to saliva collection. 4.Persons who regularly use medications or Food with Health Claims (including Food for Specified Health Uses (FOSHU), Food with Function Claims, and Food with Nutrient Function Claims) that may affect the oral environment. 5.Persons who are at risk of developing allergies related to the test foods 6.Persons who regularly use the test solution on a routine basis. 7.Persons who are judged unsuitable as research subjects based on their responses to a background survey 8.Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research. 9.Persons who are breastfeeding, pregnant, or have plans to become pregnant during the study period 10.Persons who are judged to be ineligible by the principal investigator Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 25 Day Date of IRB - 2026 Year 01 Month 24 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069127

Disclaimer: Curated by HT Syndication.