Safety and Tolerability Evaluation of Akkermansia Muciniphila
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWecare Probiotics Co., Ltd.
About this trial
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Probiotic
- Maltodextrin
Treatment groups
108 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov