Status:
COMPLETED
Effects of Yakult Ingestion in Residents and Staffs at Indonesian Elderly Houses
Lead Sponsor:
Endang Sutriswati Rahayu
Collaborating Sponsors:
Yakult Honsha Co., LTD
Conditions:
Healthy
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief 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. T...
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05308745
Start Date
October 4 2018
End Date
March 24 2022
Last Update
April 4 2022
Active Locations (3)
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1
Wana Seraya Elderly House
Denpasar, Badung, Indonesia
2
Tresna Werda Jara Mara Pati Elderly House
Singaraja, Buleleng, Indonesia, 81152
3
Werdha Santi Elderly House
Tabanan, Indonesia, 82112