The effects of a probiotic milk drink, Yakult®, containing Lactobacillus casei Shirota on the intestinal microbiota and intestinal environment in residents and staff at elderly houses in Indonesia
Tahapan Penelitian : Complete
Sponsor:
Yakult Honsha Co., LTD. 1-19, Higashi-Shimbashi 1-chome, Minato-ku Tokyo 105-8660 (Japan) Tel: +81 (0)3 3574 8968 Fax: +81 (0)3 3574 7049
Mitra Pelaksana:
Prodia CRO
No Registry
INA-78S909M
Tanggal Input Registry : 30-12-2020
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 29-09-2018 |
| Outcome Primer | • Primary end points: beneficial impact of Yakult on intestinal microbiota and intestinal environment compared to Placebo. Following parameters will be evaluated: Number and ratio of beneficial bacteria (ex. Bifidobacterium) and harmful bacteria (Enterobacteriaceae, Enterococcus, C. perfringens, C. difficile etc.) |
| Outcome Skunder | • Secondary end points: o Frequency of bowel movements (BS score) o Abdominal symptom scores (Chinese Constipation Questionnaire: CCQ) o Amount of SCFAs o Amount of putrefactive products |
| Descriptive Information | |
| Judul Penelitian Popular | The effects of a probiotic milk drink, Yakult®, containing Lactobacillus casei Shirota on the intestinal microbiota and intestinal environment in residents and staff at elderly houses in Indonesia |
| Judul Penelitian Ilmiah | The effects of a probiotic milk drink, Yakult®, containing Lactobacillus casei Shirota on the intestinal microbiota and intestinal environment in residents and staff at elderly houses in Indonesia |
| Jenis Penelitian | Bioequivalence study |
| Intervensi | Intervention Group : Yakult®: Fermented milk drink containing over 6.5×109 CFUs of L. casei Shirota/65 ml, 1 bottle/day for 24 weeks (168 days). Placebo Group : Placebo: Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product. 1 bottle/day for 24 weeks (168 days). |
| Jumlah Subyek Penelitian | 112 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Understand, and sign written informed consent. 2. No history of an adverse reaction to any of the components of the active or placebo versions of the probiotic product. 4. Can eat, regularly. 5. Has been diagnosed by doctors as healthy both physically and mentally. 6. Can abide by the experimental protocol.Exclusion Criteria: 1. Excessive alcohol consumption (defined as follows: male; over 28 glasses a week, female; over 21 glasses/week). 2. Consume antibiotics or laxatives at least 2-week prior screening period. 3. Consume ingestion of fermented dairy foods (yogurt), probiotic foods and/or prebiotic at least 2 weeks prior to the study. 4. Reported current usage of Narcotics and Psychotropic, 5. History of GI surgery i.e. Colectomy and Enterectomy. 6. Symptoms meeting to Rome IV diagnostic criteria for irritable bowel syndrome [9] 7. Pregnant or childbearing women |
| Administrative Information | |
| Nomor Persetujuan Etik | KE/FK/0202/EC/2018 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | - |
| Contact Person | Prof. Dr. Ir. Endang S Rahayu, MS |