Safety and Tolerability Evaluation of Akkermansia Muciniphila

Launched by WECARE PROBIOTICS CO., LTD. · Dec 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a substance called Akkermansia muciniphila Akk11 to see how it affects obesity and overall metabolic health in adults. The goal is to find out if this treatment can help people who are overweight or obese improve their health. The trial is currently looking for participants aged 18 to 50, including both men and women. To be eligible, healthy participants need to have a normal weight, while those who are obese must have a body mass index (BMI) of 30 or higher and have maintained their weight for the past three months.

Participants in the study can expect to receive either the treatment or a placebo (a treatment that looks the same but has no active ingredients) to compare results. All participants must agree to follow the study rules and provide consent before starting. It’s important to note that those who smoke or are pregnant are not eligible to participate. This trial aims to gather valuable information that could help in the fight against obesity and its related health issues in the future.

Gender

ALL

Eligibility criteria

• 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.