Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062366) titled 'A study to investigate the effects of a beverage containing wheat fermentation extract on the balance of gut microbiota' on July 31.

Study Type: Interventional

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

Primary Sponsor: Institute - Control of Innate Immunity Collaborative Innovation Partnership

Condition: Condition - Healthy adults and adults with mild chronic symptoms that do not substantially interfere with daily life Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of 12-week consumption of a beverage containing wheat fermentation extract, whose main functional component is lipopolysaccharide (LPS), on the gut microbiota of healthy adults and adults with mild chronic symptoms who are not receiving regular medical treatment. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Participants consume the beverage containing wheat fermentation extract for 12 weeks. Two sachets are taken twice daily, on an empty stomach after waking and before bedtime (four sachets/day). Each 16.5-mL sachet contains 600 ug of LPSp, corresponding to 2,400 ug of LPSp per day.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Adults aged 20 years or older and younger than 80 years at the time of consent. 2) Healthy adults or adults with mild chronic subjective symptoms-such as fatigue, altered bowel habits, cold sensitivity, mild sleep disturbance, mild skin symptoms, or shoulder stiffness-that do not substantially limit daily life, work, or household activities. 3) Individuals not currently receiving regular medical treatment. 4) Individuals who receive an explanation of the study, understand its contents, and provide written informed consent. 5) Individuals considered eligible by the principal investigator and study physician based on the questionnaire, medical history, medication use, and symptom severity. Key exclusion criteria - 1) Pregnant or breastfeeding women. 2) Smokers. 3) Individuals who consumed a beverage containing wheat fermentation extract within 6 months before study initiation. 4) Individuals participating in or planning to participate in another clinical trial. 5) Individuals receiving regular medical treatment, whose symptoms are worsening, who have acute symptoms, or who are considered to require medical management. 6) Individuals suspected of small intestinal bacterial overgrowth (SIBO), based on severe abdominal bloating, chronic abdominal symptoms, or worsening symptoms after fermented foods, and judged ineligible by the principal investigator or study physician. 7) Any other individuals judged unsuitable for participation by the principal investigator or study physician. Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 19 Day Date of IRB - 2026 Year 07 Month 06 Day Anticipated trial start date - 2026 Year 07 Month 14 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071376

Disclaimer: Curated by HT Syndication.