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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308745
• Other study ID #: YH.03.2018
• Status: Completed
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: March 24, 2022

Study information

• Verified date: April 2022
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Yakult®
Fermented milk drink containing over 6.5×10^9 CFUs of L. casei Shirota/65 ml
• Placebo
Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Endang Sutriswati Rahayu	Yakult Honsha Co., LTD

Country where clinical trial is conducted

Indonesia, 

Outcome

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