Healthy Clinical Trial
Official title:
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
Verified date | April 2022 |
Source | Gadjah Mada University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study to investigate the effect of Yakult® containing L. casei Shirota on the intestinal microbiota, intestinal environment, and stool frequency in healthy adult and elderly subjects in Indonesia. The clinical phase of this study was conducted for 26 weeks in three different elderly houses. The subjects were grouped into two categories: probiotic and placebo group, according whether the subjects consumed product or placebo samples. Fecal sampling were taken three times during the study.
Status | Completed |
Enrollment | 112 |
Est. completion date | March 24, 2022 |
Est. primary completion date | October 18, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | Inclusion Criteria: - Understand and sign written informed consent - Healthy adult and elderly subjects (adult: between 18 - 69 years old; elderly at least 70 years old. - No history of an adverse reaction to any of the components of the active or placebo versions of the probiotic product. - Can eat, regularly. - Has been diagnosed by doctors as healthy both physically and mentally. - Can abide by the experimental protocol. Exclusion Criteria: - Excessive alcohol consumption (defined as follows: male; over 28 glasses a week, female; over 21 glasses/week). - Consume antibiotics or laxatives at least 2-week prior screening period. - Consume ingestion of fermented dairy foods (yogurt), probiotic foods and/or prebiotic at least 2 weeks prior to the study. - Reported current usage of Narcotics and Psychotropic, - History of GI surgery i.e. Colectomy and Enterectomy. - Symptoms meeting to Rome IV diagnostic criteria for irritable bowel syndrome - Pregnant or childbearing women |
Country | Name | City | State |
---|---|---|---|
Indonesia | Wana Seraya Elderly House | Denpasar | Badung |
Indonesia | Tresna Werda Jara Mara Pati Elderly House | Singaraja | Buleleng |
Indonesia | Werdha Santi Elderly House | Tabanan |
Lead Sponsor | Collaborator |
---|---|
Endang Sutriswati Rahayu | Yakult Honsha Co., LTD |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Beneficial impact of Yakult on intestinal microbiota and intestinal environment compared to Placebo | Fecal samples will be analyzed for its microbiota composition using YIF-SCAN (Yakult Intestinal Flora Scan) and 16S rRNA gene sequencing will be utilized to measure the intestinal microbiota. The basic principle of YIF-SCAN is the quantitative RT-PCR method. The microbiota composition that will be analyzed is the number and ratio of beneficial bacteria (ex. Bifidobacterium) and harmful bacteria (Enterobacteriaceae, Enterococcus, C. perfringens, C. difficile etc.) | up to 23 months | |
Secondary | Frequency of bowel movements | Using the Bristol Stool scale and stool frequency questionnaire, the frequency of bowel movements are measured as Bristol Stool score | up to 23 months | |
Secondary | Abdominal symptom scores | Using the Chinese Constipation questionnaire, bowel function and rectal symptoms are documented | up to 23 months | |
Secondary | The concentration of total short chain fatty acids | The level of several short-chain fatty acids are measured from stool samples. These fatty acids are acetic acid, propionic acid, butyric acid, iso-butyric acid, succinic acid, lactic acid, formic acid, iso-valeric acid, valeric acid | up to 23 months | |
Secondary | The contents of putrefactive production | The concentration of several putrefactive compounds are measured from stool samples. These compounds include ammonia, phenol, indole, p-cresol. | up to 23 months |
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