Safety and Tolerability Evaluation of Heat-Inactivated Akkermansia Muciniphila Akk11: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Changes in stool quality
Study Overview
Brief Summary
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Inactivated Akk11
Healthy Subjects Receiving Probiotic Inactivated Akk11: One probiotic Akkermansia muciniphila Akk11 capsule daily (30 billion TFU/capsule).
Store in cool and dry place, without exposure to light.
Intervention: Probiotic (Dietary Supplement)
Placebo
Healthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light.
Intervention: Maltodextrin (Dietary Supplement)
Live Akk11
Healthy Subjects Receiving Probiotic live Akk11: One probiotic Akkermansia muciniphila Akk11 capsule daily (30 billion AFU/capsule).
Store in cool and dry place, without exposure to light.
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in stool quality
Time Frame: 30 days
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.
Secondary Outcomes
No secondary outcomes reported