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

Endang Sutriswati Rahayu

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Yakult®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05308745

YH.03.2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 95 years old

Volunteers

Accepts Healthy Volunteers

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