Opunxia clinical trial. Effect of Opunxia™ supplementation on overall health through an improvement of the intestinal microbiome in subjects with dysbiosis

BIONAP srl0 个研究点目标入组 80 人开始时间: 2022年5月5日最近更新: 2024年4月29日

适应症

试验速览

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38474715/ (added 17/04/2024)

•1. Subjects <25 and >50 years old
•2. Clinical history with the relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study
•3. Consumption of any drugs or food supplements that can interfere with intestinal activity
•4. Smokers
•5. Lack of compliance (defined as not using the correct Opuntia™ dose or placebo for>1 week), and inability to give informed consent
•6. BMI =30 kg/m²
•7. Pregnant and lactating women
•8. Excessive alcohol consumption (>5 drinks/week)
•9. Subjects with a history of drug, alcohol, and other substance abuse
•10. Known food intolerance or food allergy
•11. Subjects involved in a clinical or food study within the previous month
•12. Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension, hypotension, diabetes mellitus, kidney failure)
•13. Subjects with a history of paralysis or cerebral vascular accident
•14. Subjects with active cancers or on chemotherapy
•15. Other factors that limit their ability to cooperate during the study

发起方