A Double-Blind, Randomized, Two-Arm, Placebo-Controlled, Comparative Clinical Study to Evaluate the Safety and Efficacy of Bacillus coagulans BCP92 in Healthy Adult Subjects. - NI

Pellucid Lifesciences Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

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•1) Subjects having good general health as determined by the Investigator on the basis of medical history, physical examination and vital signs.
•2) Females of Childbearing potential must have a negative urine pregnancy test performed during screening.
•3) Subjects who agree to refrain from using any probiotic food or supplement, including yogurt/buttermilk during the course of this study.
•4) Subjects who agree to refrain from consuming pharmaceuticals such as anti-inflammatory, immunosuppressive, and laxative agents.
•5) Subjects willing to maintain a consistent diet and lifestyle routine throughout the study.
•6) Subject willing to provide blood and stool samples during the study duration.

•1) Subjects having history of acute peptic ulcer, severe GERD and/or ulcer complications or other functional GI disorder.
•2) Subjects with any pathological problem associated with gastroesophageal reflux disease including Barretts esophagus and malignancy.
•3) Subjects with any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition which in the opinion of the Investigator could jeopardize the safety of the subject or impact the validity of the study results or interfere with the completion of study according to the protocol.
•4) Subjects who are regularly using any medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
•5) Subjects consuming probiotics or prebiotics 30 days prior to study.
•6) Subjects with known allergy or hypersensitivity to probiotics and/or any ingredients of the test product.

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