Safety and Tolerability Evaluation of Akkermansia Muciniphila
NCT ID: NCT06728098
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2025-11-25
2026-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Probiotic
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
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.
Probiotic
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Placebo
Healthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light.
Maltodextrin
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Interventions
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Probiotic
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Maltodextrin
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
Yes
Sponsors
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Wecare Probiotics Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WK2024017
Identifier Type: -
Identifier Source: org_study_id
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