Healthy AdultNCT06385639
Efficacy and Safety of Probiotic Products for Digestive Health
A study testing Probiotic in people with Healthy Adult, run by Wecare Probiotics Co., Ltd. at 1 site in Indonesia.
Trial summary
The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Apr 2024to 25 Jun 2024
- 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 subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)
Who cannot join
- History of 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 probiotic 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
Show all 9Show fewer
- 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
Danang@Equilab-Int.Com
Jakarta, Pusat, 10430
Danang A. Yunaidi, MD, 217515932 ext. +62, danang@equilab-int.com
About this study
Official title: A Double-blind, Randomized Clinical Study, Compared With Placebo to Assess the Efficacy and Safety of a Probiotic Product Containing Four Probiotic Strains to Support Digestive Environment and Homeostasis of Gut Microbiota
The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota.
- Conditions
- Healthy Adult
- Being tested
- Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
This clinical trial will last for 10 days, and each subject will have 4 follow-up visits (Day -1, Day 0, Day 10, Day 20).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Two sachets/day probiotics, before breakfast and dinner, respecitvely Receives: Dietary Supplement: Probiotic |
| Placebo Group | Placebo comparator | Maltodextrin, Two sachets/day probiotics, before breakfast and dinner, respecitvely Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal health
Changes in short-chain fatty acid (SCFA) from baseline to day 10
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion25 May 2024 (estimated)
- Study completion25 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT06385639
- Sponsor's protocol ID
- WK2024005
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Clinical Study, Compared With Placebo to Assess the Efficacy and Safety of a Probiotic Product Containing Four Probiotic Strains to Support Digestive Environment and Homeostasis of Gut Microbiota
- ClinicalTrials.gov ID
- NCT06385639
- Acronym / sponsor ID
- WK2024005
- Conditions
- Healthy Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 26 Apr 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.
The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: ProbioticTwo sachets/day probiotics, before breakfast and dinner, respecitvely |
| Placebo Group | Placebo comparator | Dietary Supplement: ProbioticMaltodextrin, Two sachets/day probiotics, before breakfast and dinner, respecitvely |
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 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 probiotic 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 |
|---|---|---|
| ProbioticThis clinical trial will last for 10 days, and each subject will have 4 follow-up visits (Day -1, Day 0, Day 10, Day 20). | Dietary supplement | Placebo Group, Probiotic Group |
Primary outcome
Intestinal health
Time frame: 10 days
Changes in short-chain fatty acid (SCFA) from baseline to day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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 in people with Healthy Adult, 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 26 Apr 2024. 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 Danang A. Yunaidi, MD (021 7515932 ext. ＋62, danang@equilab-int.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal health (time frame: 10 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 26 Apr 2024.