A prospective, randomized, double-blind, two-arm, parallel, placebo-controlled, clinical study to evaluate the efficacy of OPTIMEALTH® FOOD P supplementation on constipation symptoms, SCFAS content, and gut microbiota composition in healthy participants suffering from constipation

INNOVATION LABO SCIENCES Co., Ltd0 个研究点目标入组 60 人开始时间: 2024年8月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Healthy adult subjects between 21 and 65 years (inclusive) of age
•2. General symptoms of constipation and meet ROME III criteria for functional constipation
•3. BMI between 18.5 and 29.9 Kg/m²
•4. Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result at the screening visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
•5. Willing to give written informed consent and be willing to comply with trial protocol
•6. The ability to understand the risks/benefits of the protocol
•7. Available for the duration of the study period (6 weeks)

•1. Constipation due to organic or neurological lesions
•2. A history of pathological bowel diseases like IBD or colon cancer
•3. Abnormal liver or renal function
•4. Taken any prebiotic, probiotic or laxative supplements within 8 weeks from the start of the study period
•5. Receiving any antibiotic, anti-inflammatory or immunosuppressive drug within the past 4 weeks
•6. Known allergies to soy milk or any other test product ingredients
•7. Alcoholics and or drug abusers
•8. Pregnant or lactating females
•9. A history of anxiety or depression or recent intake of psychotropic drugs
•10. Any other condition which the Principal Investigator thinks may jeopardize the study outcome

发起方

INNOVATION LABO SCIENCES Co., Ltd