UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061182 |
|---|---|
| Receipt number | R000069619 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Superiority Trial on the Effects of Synbiotics on the Gut Microbiome in Healthy Elderly Individuals |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/03/31 09:10:02 |
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Basic information
Public title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Superiority Trial on the Effects of Synbiotics on the Gut Microbiome in Healthy Elderly Individuals
Acronym
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Superiority Trial on the Effects of Synbiotics on the Gut Microbiome in Healthy Elderly Individuals
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Superiority Trial on the Effects of Synbiotics on the Gut Microbiome in Healthy Elderly Individuals
Scientific Title:Acronym
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Superiority Trial on the Effects of Synbiotics on the Gut Microbiome in Healthy Elderly Individuals
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of synbiotic intake on the gut environment in healthy elderly individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota
Key secondary outcomes
<Secondary Evaluation Items>
1) Organic acids in stool
2) Stool pH
3) Putrefactive products in stool
4) Defecation status (fecal odor, stool consistency, frequency, stool volume)
5) Mood Profile Test
6) High-Sensitivity CRP
7) Sleep Status
8) NAD+
9) Body Composition
10) Skin Condition
<Safety>
Adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of synbiotic powder (2 sticks in a day; 4 weeks).
Interventions/Control_2
Oral intake of the placebo powder (2 sticks in a day; 4 weeks).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals aged 65 or older but under 75 at the time of obtaining the informed consent document for trial participation.
Key exclusion criteria
1) Individuals currently suffering from any chronic disease and undergoing drug therapy.
2) Individuals regularly taking medications that affect the intestinal environment (such as antibiotics, intestinal regulators, laxatives, or purgatives).
3) Individuals regularly consuming foods or supplements containing bacteria such as lactic acid bacteria or bifidobacteria, oligosaccharides, or other ingredients that affect the intestinal environment or intestinal function.
4) Individuals with severe anemia.
5) Individuals with a BMI of 30 kg/m2 or higher.
6) Individuals whose average weekly alcohol consumption exceeds 40 g/day for men and 20 g/day for women, based on pure alcohol content.
7) Individuals with a smoking habit.
8) Individuals participating in other human clinical trials.
9) Individuals receiving treatment for liver, kidney, heart, lung, digestive, blood, nervous system, endocrine system, or metabolic disorders, or individuals with a history of severe conditions in these areas.
10) Individuals with a history of drug allergies or severe food allergies.
11) Individuals who underwent blood collection of 400 mL or more within 12 weeks prior to the start of intake.
12) Individuals deemed unsuitable as subjects by the study physician based on results from subject background, physical examination findings, medical history and physical examination, physical examination, and laboratory tests.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Shigefumi |
| Middle name | |
| Last name | Kitagawa |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Health Care & Nutritional Science Institute R&D Division
Zip code
252-8583
Address
5-1-83, Higashihara, Zama city, Kanagawa, Japan
TEL
046-252-3057
s_kitagw@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069619
