Effects of Yakult Ingestion in Residents and Staffs at Indonesian Elderly Houses

Study Overview
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Brief Summary
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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.

Detailed Description
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The study investigates the ingestion effect of a commercialized probiotic milk drink, Yakult®, for residents and staffs at Indonesian elderly houses (age limit: 18 - 95 years old). The study will be conducted as a double blind, placebo controlled parallel comparison study. There will be 26 weeks used for the study, comprised of: A 2-week baseline assessment period, and 24-week probiotic or placebo intake period. From 112 subjects, the participants will be grouped into two: probiotic and placebo group. Those in probiotic group will consume Yakult® (Fermented milk drink containing over 6.5×10^9 CFUs of L. casei Shirota/65 ml), while placebo group will consume the placebo product (taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product). The treatment intake will be done for 24 weeks (182 days). During the study, the participants are expected to fill questionnaire of frequency of bowel movements and Chinese Constipation Questionnaire to obtain the defecation frequency (Bristol Stool score) and abdominal symptom scores. Fecal samples will be collected three times: on the last day of the baseline period (day 14±1), 12 weeks (day 98±1) after intake period, after the 24-weeks intake period (day 182±1). Afterwards, the obtained fecal samples will be further analyzed for its microbial composition, level of short-chain fatty acids and putrefactive compounds.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Yakult®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic group<br>Participants within this group consumed Yakult® as research product 1 bottle/day for 24 weeks (168 days). | Dietary Supplement: Yakult®<br>* Fermented milk drink containing over 6.5×10^9 CFUs of L. casei Shirota/65 ml<br>|
| Placebo Comparator: Placebo group<br>Participants within this group consumed placebo as research product 1 bottle/day for 24 weeks (168 days). | Dietary Supplement: Placebo<br>* Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Abdominal symptom scores | Using the Chinese Constipation questionnaire, bowel function and rectal symptoms are documented | up to 23 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, elderly subject, intestinal microbiota