HealthyNCT05308745
Effects of Yakult Ingestion in Residents and Staffs at Indonesian Elderly Houses
A study testing Yakult® in people with Healthy, run by Endang Sutriswati Rahayu at 3 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Yakult®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 3 sitesIndonesia
- Study dates
- 4 Oct 2018to 24 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Wana Seraya Elderly House
Denpasar, Badung
Tresna Werda Jara Mara Pati Elderly House
Singaraja, Buleleng, 81152
Werdha Santi Elderly House
Tabanan, 82112
About this study
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
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.
Read the 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 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.
- Conditions
- Healthy
- Being tested
- Yakult®, Placebo
- Keywords
- probiotic, elderly subject, intestinal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yakult®Dietary supplement
Fermented milk drink containing over 6.5×10^9 CFUs of L. casei Shirota/65 ml
PlaceboDietary supplement
Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Participants within this group consumed Yakult® as research product 1 bottle/day for 24 weeks (168 days). Receives: Dietary Supplement: Yakult® |
| Placebo group | Placebo comparator | Participants within this group consumed placebo as research product 1 bottle/day for 24 weeks (168 days). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: up to 23 months
Secondary outcomes (4)
Frequency of bowel movements
Using the Bristol Stool scale and stool frequency questionnaire, the frequency of bowel movements are measured as Bristol Stool score
Measured: up to 23 months
Abdominal symptom scores
Using the Chinese Constipation questionnaire, bowel function and rectal symptoms are documented
Measured: 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
Measured: 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.
Measured: up to 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start4 Oct 2018
- Primary completion18 Oct 2018
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endang Sutriswati Rahayu
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Responsible party
- Sponsor-investigator, Endang Sutriswati Rahayu, Gadjah Mada University
- Investigators
- Endang Sutriswati Rahayu, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308745
- Sponsor's protocol ID
- YH.03.2018
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05308745
- Acronym / sponsor ID
- YH.03.2018
- Conditions
- Healthy
- Keywords
- probiotic, elderly subject, intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Endang Sutriswati RahayuUniversity, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: Yakult®Participants within this group consumed Yakult® as research product 1 bottle/day for 24 weeks (168 days). |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboParticipants within this group consumed placebo as research product 1 bottle/day for 24 weeks (168 days). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yakult®Fermented milk drink containing over 6.5×10^9 CFUs of L. casei Shirota/65 ml | Dietary supplement | Probiotic group |
| PlaceboTaste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product | Dietary supplement | Placebo group |
Primary outcome
Beneficial impact of Yakult on intestinal microbiota and intestinal environment compared to Placebo
Time frame: up to 23 months
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.)
4 secondary outcomes
Frequency of bowel movements
Time frame: up to 23 months
Abdominal symptom scores
Time frame: up to 23 months
The concentration of total short chain fatty acids
Time frame: up to 23 months
The contents of putrefactive production
Time frame: up to 23 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Endang Sutriswati Rahayu principal investigator
Gadjah Mada University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yakult® in people with Healthy, run by Endang Sutriswati Rahayu at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beneficial impact of Yakult on intestinal microbiota and intestinal environment compared to Placebo (time frame: up to 23 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.