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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementThe experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Maltodextrin
Dietary supplementThe experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Live Akk11Experimental treatment 1 intervention
Group B: Inactivated Akk11Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in stool quality
Stool consistency (using the Bristol Stool Scale) from baseline to day 30. The Bristol Stool Scale is a tool to assess gut health by classifying feces into seven categories based on shape and consistency: types 1-2 indicate constipation, 3-4 are normal, and 5-7 suggest diarrhea.
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov