UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055862 |
|---|---|
| Receipt number | R000063844 |
| Scientific Title | A randomized, double-blind, placebo-controlled crossover study on the effect of increasing bifidobacteria by lactulose intake in healthy adults. |
| Date of disclosure of the study information | 2024/11/29 |
| Last modified on | 2025/12/12 13:09:09 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled crossover study on the effect of increasing bifidobacteria by lactulose intake in healthy adults.
Acronym
A study on the effect of increasing bifidobacteria by lactulose intake in healthy adults.
Scientific Title
A randomized, double-blind, placebo-controlled crossover study on the effect of increasing bifidobacteria by lactulose intake in healthy adults.
Scientific Title:Acronym
A study on the effect of increasing bifidobacteria by lactulose intake in healthy adults.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of increasing bifidobacteria by lactulose intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota (Relative abundance of bifidobacteria)
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion of lactulose for 4 weeks.
Interventions/Control_2
Daily ingestion of placebo for 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Healthy males and females who are aged 18-64 years at the time of obtaining consent.
2 Subjects who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.
Key exclusion criteria
1 Subjects undergoing treatment for serious cancer, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine or metabolic diseases, or those with a serious history of these diseases.
2 Subjects with a history of surgery on their digestive tract (excluding adenoidectomy, appendicitis, etc.).
3 Subjects with gastrointestinal disorders such as irritable bowel syndrome and inflammatory bowel disease.
4 Subjects who regularly take medicine that affects intestinal environment.
5 Subjects who regularly take foods with function claims, foods for specified health uses or supplements that affect intestinal environment.
6 Subjects with serious allergies to drugs or foods, or those with a history of them.
7 Subjects with milk allergy
8 Subjects with lactose intolerance.
9 Pregnant or breastfeeding women or women who expect to become pregnant during this study.
10 Subjects who consume more than 60 g of pure alcohol per day.
11 Subjects with a smoking habit.
12 Subjects who have participated in other clinical trials within 3 months of consent or who plan to participate in other clinical trials during this study period.
13 Subjects who are judged ineligible to this study by principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anera Bldg. 8F, 3-3-3 Higashi Nihonbashi, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2024 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.31989/ffhd.v15i12.1838
Number of participants that the trial has enrolled
100
Results
The lactulose intervention resulted in a significant increase in the relative abundance of Bifidobacterium compared with the placebo intervention.
(Reference)
Sakiyama R., Miyashita S., Nakano M., Tanaka M. Ultra-low-dose lactulose modulates the gut microbiota in healthy adults: A double-blind, randomized, placebo-controlled crossover trial. Functional Foods in Health and Disease 2025; 15(12): 907 - 920. DOI: https://doi.org/10.31989/ffhd.v15i12.1838
Results date posted
| 2025 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063844
