ISRCTN16659746
Completed
未知
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 sites60 target enrollmentAugust 5, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Improvement of constipation symptoms
- Sponsor
- INNOVATION LABO SCIENCES Co., Ltd
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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