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

NCT05308745 | Completed

• 1 other identifier: YH.03.2018
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

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. 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.

Conditions

Healthy

Keywords

probiotic; elderly subject; intestinal microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Frequency of bowel movements

  up to 23 months

• Abdominal symptom scores

  up to 23 months

• The concentration of total short chain fatty acids

  up to 23 months

• The contents of putrefactive production

  up to 23 months

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

Participants within this group consumed Yakult® as research product 1 bottle/day for 24 weeks (168 days).

Dietary Supplement: Yakult®

Placebo group

PLACEBO COMPARATOR

Participants within this group consumed placebo as research product 1 bottle/day for 24 weeks (168 days).

Dietary Supplement: Placebo

Interventions

Yakult® DIETARY_SUPPLEMENT

Fermented milk drink containing over 6.5×10\^9 CFUs of L. casei Shirota/65 ml

Probiotic group

Placebo DIETARY_SUPPLEMENT

Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product

Placebo group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Endang Sutriswati Rahayu: lead
• Yakult Honsha Co., LTD: collaborator

Study Sites (3)

Wana Seraya Elderly House

Denpasar, Badung, Indonesia

Location

Tresna Werda Jara Mara Pati Elderly House

Singaraja, Buleleng, 81152, Indonesia

Location

Werdha Santi Elderly House

Tabanan, 82112, Indonesia

Location

Study Officials

• Endang Sutriswati Rahayu

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Ir.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: October 4, 2018
• Primary Completion: October 18, 2018
• Study Completion: March 24, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-04

Locations

ID (3)