Safety and Tolerability Evaluation of Akkermansia Muciniphila

Wecare Probiotics

Status: Enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06728098

WK2024017

Details and patient eligibility

About

This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female subject age 18-60 years at screening.
2. Healthy subject according to investigator judgement based on screening data.
3. 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.
4. Subjects who have not smoked in the past 1 month prior to screening.
5. Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption.
6. Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol.
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any trial related activities).

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups, including a placebo group

Live Akk11

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Inactivated Akk11

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Healthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light.

Treatment:

Dietary Supplement: Maltodextrin