RecruitingNot ApplicableNCT06974266

An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia


Sponsor

Moon (Guangzhou) Biotechnology Co., Ltd.

Enrollment

60 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled trial, eligible hypercholesterolemic participants were administered daily oral doses of either AKM Lab-01 or a placebo. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.


Eligibility

Min Age: 35 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and Probiotic for people with hypercholesterolaemia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 35 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotic

Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.

DIETARY_SUPPLEMENTPlacebo

Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.


Locations(1)

PKUCare Luzhong Hospital

Zibo, Shandong, China

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NCT06974266


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