UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061180 |
|---|---|
| Receipt number | R000070000 |
| Scientific Title | Effect of Lactococcus lactis subsp. cremoris H61 (heat-killed) on iron absorption and iron status in healthy adults: A systematic review |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/06 15:40:40 |
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Basic information
Public title
A systematic review of the effects of Lactococcus lactis subsp. cremoris H61 (heat-killed) on supporting iron supplementation
Acronym
H61-IRON Review
Scientific Title
Effect of Lactococcus lactis subsp. cremoris H61 (heat-killed) on iron absorption and iron status in healthy adults: A systematic review
Scientific Title:Acronym
H61-IRON-SR
Region
| Japan |
Condition
Condition
Healthy adults (generally aged 18 years or older) without apparent iron-deficiency anemia or chronic diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To systematically evaluate whether continuous intake of Lactococcus lactis H61 improves iron absorption or iron status in healthy individuals compared with no intake or placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum ferritin level
Key secondary outcomes
Serum iron, transferrin saturation (TSAT), hemoglobin, and other iron metabolism-related parameters. If direct indicators of iron absorption, such as those measured using stable isotope techniques, are reported, they will also be evaluated.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants
Healthy adults (generally aged 18 years or older) without apparent iron-deficiency anemia or chronic diseases
Interventions
Continuous intake of Lactococcus lactis subsp. cremoris H61 (heat-killed)
Comparators
Placebo or no intake
Outcomes
Primary outcome:
Serum ferritin
Secondary outcomes:
Serum iron, transferrin saturation (TSAT), hemoglobin, and other iron metabolism-related parameters
If direct indicators of iron absorption, such as those measured using stable isotope techniques, are reported, they will also be evaluated.
Study design
Randomized controlled trials (RCTs) and non-randomized intervention studies
Key exclusion criteria
Animal studies, in vitro studies, studies including only patients with specific diseases, studies using lactic acid bacteria other than H61 alone, and studies that did not report iron-related outcomes
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Takeuchi |
Organization
Association of Japan CAM
Division name
N/A
Zip code
1510053
Address
#306 Onogibiru,3-46-16 Yoyogi, Shibuya-ku, Tokyo
TEL
0364574911
info@ajcam.biz
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N/A
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
TOA BIOPHARMA 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
Japan Clinical Trial Association
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574666
info@yakujihou.org
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 | 20 | 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 | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Objective and Information Sources]
This review aims to evaluate the effects of continuous intake of Lactococcus lactis subsp. cremoris H61 (heat-killed) on iron absorption and iron status in healthy adults. PubMed, JDreamIII, UMIN-CTR, and ClinicalTrials.gov will be searched from their inception.
[Search Strategy]
Search strategies were developed based on the PICOS framework through consensus between two reviewers. Because Lactococcus lactis subsp. cremoris H61 is a strain-specific intervention with a limited number of studies, the search focuses on the intervention to avoid missing studies in which iron-related outcomes (e.g., hemoglobin, ferritin) are assessed as secondary outcomes and not explicitly stated in titles or abstracts. Iron-related outcomes will be confirmed during full-text screening. Reference lists of included studies will be hand-searched.
[Selection Process]
Records will be managed using reference management software, and duplicates will be removed. Two independent reviewers will screen titles, abstracts, and full texts. Disagreements will be resolved by discussion or by a third reviewer. Peer-reviewed original articles will be prioritized.
[Data Collection and Items]
Data will be independently extracted using standardized forms. Items include author, journal, title, study design, PICO, setting, participant characteristics, intervention, comparator, analytical methods, outcomes, adverse events, peer-review status, and funding sources.
[Outcomes and Assessment]
The primary outcome is serum ferritin. Other iron status indicators will be evaluated as secondary outcomes. Risk of bias will be assessed using the Minds Manual 2020 and the Cochrane Handbook (Version 6.5).
[Data Synthesis and Confidence]
A narrative synthesis will be conducted due to expected heterogeneity. Meta-analysis will be considered if sufficient data are available. Publication bias will be assessed, and certainty of evidence will be evaluated using the GRADE approach.
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070000
