Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063360) titled 'Exploratory study on the effects of intake of "Kodomo Cho-miso" on gut microbiota and quality of life (QOL) in children' on Oct. 20.

Study Type: Interventional

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

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

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

Objective: Narrative objectives1 - To exploratorily evaluate the changes in gut microbiota and parent-reported abdominal QOL, daily life (behavior/emotion), and defecation status when ingested continuously for 4 weeks in children aged 9 months to 6 years. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake daily for 4 weeks (28 days) once a day of the test food dissolved in hot water according to age in months (9-11 months: 2 g, 1-2 years: 4 g, 3-5 years: 5 g, 6 years and older: 7 g).

Eligibility: Age-lower limit - 9 months-old = Gender - Male and Female Key inclusion criteria - 1. Children whose surrogates (guardians) have received sufficient explanation about the purpose and contents of this study, fully understand it, and have agreed to the participation of the study subjects of their own free will 2. Japanese children aged between 9 months and 6 years at the time of obtaining consent (guideline: after completion of baby food) 3. Persons who can incorporate the test food into their diet almost every day for 4 weeks Key exclusion criteria - 1. Persons who are allergic to the raw materials of the test food, or are undergoing close examination for food allergies 2. Persons who have chronic gastrointestinal diseases, renal dysfunction, diseases requiring sodium (salt) restriction, etc. and are receiving treatment, or have a serious disease history 3. Persons who have taken antibiotics within 4 weeks before the start of the study 4. Persons who regularly use supplements such as probiotics and prebiotics, or foods with health claims that may affect the intestinal environment, and cannot stop taking them 5. Persons who usually take a large amount of miso products of the same type as the test food 6. Persons who have participated in other studies within 1 month before the start of the study, or who intend to participate in other studies after consenting to this study 7. Persons who were judged as inappropriate for study participants by the principal investigator Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 25 Day Date of IRB - 2026 Year 10 Month 19 Day Anticipated trial start date - 2026 Year 10 Month 21 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072521

Disclaimer: Curated by HT Syndication.