ISRCTN16659746CompletedUnknown
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 enrollmentStarted: August 5, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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