A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL STUDY, TO EVALUATE THE SUPPLEMENT PRODUCT CONTAINING FOUR PROBIOTIC STRAINS IN SUPPORTING DIGESTIVE HEALTH
Tahapan Penelitian : Complete
Sponsor:
Wecare Probiotics Co., Ltd
Mitra Pelaksana:
PT Equilab International
No Registry
INA-7M7FANKF
Tanggal Input Registry : 25-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 20-01-2023 |
| Outcome Primer | Change in stool quality |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL STUDY, TO EVALUATE THE SUPPLEMENT PRODUCT CONTAINING FOUR PROBIOTIC STRAINS IN SUPPORTING DIGESTIVE HEALTH |
| Judul Penelitian Ilmiah | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL STUDY, TO EVALUATE THE SUPPLEMENT PRODUCT CONTAINING FOUR PROBIOTIC STRAINS IN SUPPORTING DIGESTIVE HEALTH |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 72 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Male or Female subject age 19-59 years at screening, Healthy subject according to investigator judgement based on screening data, defined as no clinically significant value of physical examination, vital signs, and blood glucose level, Subjects must have a body mass index (BMI) within the range of 16-40 kg/m2, Subjects 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 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)Exclusion Criteria: History of or presence of diabetes, immunodeficiency disorders, or chronic illnesses (including but not limited to cardiovascular diseases, cancer, chronic kidney disease, chronic respiratory disorders, and related medications used to treat the chronic illnesses, Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics (within 4 weeks prior to the randomization) and immunosuppressants, Use of laxatives or presence of constipation, Have continuous, daily use of other probiotics, probiotic containing products, prebiotics, sybiotics, within 4 weeks prior to randomization, Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening), Any known allergy or intolerance to any of the ingredients in the formulation of the product under study, History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study, Subject whose condition does not make them eligible to the study, according to the investigator |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-474/UN2.F1/ETIK/PPM.00.02/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |