Safety and Tolerability Evaluation of Akkermansia Muciniphila

Inclusion criteria

• Male or Female subject age 18-60 years at screening.
• Healthy subject according to investigator judgement based on screening data.
• Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for the entire study.
• Subjects who have not smoked in the past 1 month prior to screening.
• Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption.
• Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol.
• Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any trial related activities).

Exclusion criteria

• History of or presence of diabetes, immunodeficiency disorders, or chronic illness.
• Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants.
• Have continuous, daily use of probiotics or probiotic containing products within 1 month prior to randomization.
• Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening).
• Change type of diet during study.
• Any known allergy or intolerance to any of the ingredients in the formulation of the product under study.
• History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study.
• History of or presence of eating disorder.
• Subject whose condition does not make them eligible to the study, according to the investigator.