ClinicalTrials.gg
Status unknownNCT06385639Updated Apr 26, 2024

Efficacy and Safety of Probiotic Products for Digestive Health

An interventional study of Probiotic in Healthy Adult, sponsored by Wecare Probiotics Co., Ltd.. Status unknown at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Adult
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 66 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)

Exclusion criteria

Exclusion Criteria:

  1. History of 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 probiotic 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Probiotic Group

    Two sachets/day probiotics, before breakfast and dinner, respecitvely

    Dietary Supplement: Probiotic

  • Placebo comparator
    Placebo Group

    Maltodextrin, Two sachets/day probiotics, before breakfast and dinner, respecitvely

    Dietary Supplement: Probiotic

Interventions

  • Dietary supplementProbiotic

    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).

06

What researchers measure

Primary outcomes

  1. Intestinal health

    Changes in short-chain fatty acid (SCFA) from baseline to day 10

    Time frame: 10 days

07

Study locations

1 of 1 sites recruiting
  • Danang@Equilab-Int.Com
    Jakarta, Pusat 10430, Indonesia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2024; primary completion for May 2024, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2024
First posted
Apr 26, 2024
StartEst.
Apr 25, 2024
Primary completionEst.
May 25, 2024
CompletionEst.
Jun 25, 2024
Last update
Apr 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06385639
Responsible party
Sponsor
First posted
Apr 26, 2024
Start date
Apr 25, 2024 (estimated)
Primary completion
May 25, 2024 (estimated)
Completion
Jun 25, 2024 (estimated)
Last update
Apr 26, 2024

Study contacts

Danang A. Yunaidi, MD
Contact
danang@equilab-int.com
021 7515932 ext. +62

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Probiotic

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