Tokyo, April 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061182) titled 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Superiority Trial on the Effects of Synbiotics on the Gut Microbiome in Healthy Elderly Individuals' on April 7.

Study Type: Interventional

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

Primary Sponsor: Institute - TES Holdings Co., Ltd.

Condition: Condition - No Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluate the effects of synbiotic intake on the gut environment in healthy elderly individuals. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral intake of synbiotic powder (2 sticks in a day; 4 weeks). Interventions/Control_2 - Oral intake of the placebo powder (2 sticks in a day; 4 weeks).

Eligibility: Age-lower limit - 65 years-old

Gender - Male and Female Key inclusion criteria - Individuals aged 65 or older but under 75 at the time of obtaining the informed consent document for trial participation. Key exclusion criteria - 1) Individuals currently suffering from any chronic disease and undergoing drug therapy. 2) Individuals regularly taking medications that affect the intestinal environment (such as antibiotics, intestinal regulators, laxatives, or purgatives). 3) Individuals regularly consuming foods or supplements containing bacteria such as lactic acid bacteria or bifidobacteria, oligosaccharides, or other ingredients that affect the intestinal environment or intestinal function. 4) Individuals with severe anemia. 5) Individuals with a BMI of 30 kg/m2 or higher. 6) Individuals whose average weekly alcohol consumption exceeds 40 g/day for men and 20 g/day for women, based on pure alcohol content. 7) Individuals with a smoking habit. 8) Individuals participating in other human clinical trials. 9) Individuals receiving treatment for liver, kidney, heart, lung, digestive, blood, nervous system, endocrine system, or metabolic disorders, or individuals with a history of severe conditions in these areas. 10) Individuals with a history of drug allergies or severe food allergies. 11) Individuals who underwent blood collection of 400 mL or more within 12 weeks prior to the start of intake. 12) Individuals deemed unsuitable as subjects by the study physician based on results from subject background, physical examination findings, medical history and physical examination, physical examination, and laboratory tests. Target Size - 52

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 03 Day Date of IRB - 2026 Year 03 Month 05 Day Anticipated trial start date - 2026 Year 06 Month 08 Day Last follow-up date - 2026 Year 07 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069619

Disclaimer: Curated by HT Syndication.