HealthyNCT06728098
Safety and Tolerability Evaluation of Akkermansia Muciniphila
A study testing Probiotic and Maltodextrin in people with Healthy, run by Wecare Probiotics Co., Ltd. at 1 site in Indonesia.
Trial summary
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Nov 2025to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
Natalina Soesilawati, 0217695513, ec_fkui@yahoo.com
About this study
Official title: Safety and Tolerability Evaluation of Heat-Inactivated Akkermansia Muciniphila Akk11: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
- Conditions
- Healthy
- Being tested
- Probiotic, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
MaltodextrinDietary supplement
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
| Study group | Role | What they receive |
|---|---|---|
| Live Akk11 | Experimental | 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. Receives: Dietary Supplement: Probiotic |
| Inactivated Akk11 | Experimental | 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. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Healthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in stool quality
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start25 Nov 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728098
- Sponsor's protocol ID
- WK2024017
- Status last verified
- Oct 2024
- First submitted
- 27 Nov 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability Evaluation of Heat-Inactivated Akkermansia Muciniphila Akk11: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06728098
- Acronym / sponsor ID
- WK2024017
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live Akk11 | Experimental | Dietary Supplement: ProbioticHealthy 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. |
| Inactivated Akk11 | Experimental | Dietary Supplement: ProbioticHealthy 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. |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinHealthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticThe experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30). | Dietary supplement | Inactivated Akk11, Live Akk11 |
| MaltodextrinThe experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30). | Dietary supplement | Placebo |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Maltodextrin in people with Healthy, run by Wecare Probiotics Co., Ltd. at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicky Achmad Ginanjar, bachelor (+62 21 7695513, 7515932 ext. +62, vicky.achmad@equilab-int.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in stool quality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.