Evaluating a probiotic product for digestive health
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
This study is testing a new probiotic product to see if it can help healthy adults improve their digestive health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Wecare Probiotics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jakarta, Pusat) |
| Trial ID | NCT06385639 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of a probiotic product designed for everyday use to support gut health and maintain a balanced gut microbiota. Participants will be healthy adults aged 18-60 who meet specific inclusion criteria, including a balanced diet and non-smoking status. The study will involve administering the probiotic and monitoring its effects on digestive health over a defined period.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-60 who maintain a balanced diet and do not smoke.
Not a fit: Patients with chronic illnesses or those taking medications that affect the gastrointestinal system may not benefit from this study.
Why it matters
Potential benefit: If successful, this could enhance digestive health and improve gut microbiota balance for participants.
How similar studies have performed: Other studies have shown positive outcomes with probiotics for digestive health, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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
Where this trial is running
Jakarta, Pusat
- Danang@Equilab-Int.Com — Jakarta, Pusat, Indonesia (Recruiting)
Study contacts
- Study coordinator: Danang A. Yunaidi, MD
- Email: danang@equilab-int.com
- Phone: 021 7515932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.