UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057850 |
|---|---|
| Receipt number | R000066102 |
| Scientific Title | An open-label, single-arm study to evaluate the efficacy of dental metal removal in the treatment of irritable bowel syndrome |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2025/05/13 10:24:04 |
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Basic information
Public title
Efficacy of dental metal removal in the treatment of irritable bowel syndrome
Acronym
Efficacy of dental metal removal in the treatment of irritable bowel syndrome
Scientific Title
An open-label, single-arm study to evaluate the efficacy of dental metal removal in the treatment of irritable bowel syndrome
Scientific Title:Acronym
An open-label, single-arm study to evaluate the efficacy of dental metal removal in the treatment of irritable bowel syndrome
Region
| Japan |
Condition
Condition
Irritable bowel syndrome
Classification by specialty
| Gastroenterology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our previous studies have revealed that the prevalence of zinc and nickel hypersensitivity is significantly higher in patients with irritable bowel syndrome (IBS). Based on these findings, this clinical trial will focus on dental metal hypersensitivity as a potential cause of IBS and evaluate whether replacing dental metals containing zinc and nickel with non-metallic materials improves IBS symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
IBS severity index (IBS-SI)
Participants' IBS symptoms will be assessed using a self-administered IBS-SI questionnaire before and after dental metal removal.
Key secondary outcomes
Functional bowel disorder severity index (FBDSI)
IBS-QOL
Drug-induced lymphocyte stimulation test (DLST)
Participants' IBS symptoms and quality of life will be assessed using self-administered FBDSI and IBS-QOL questionnaires before and after dental metal removal.
Participants' blood samples are drawn before and after dental metal removal to evaluate hypersensitivity to zinc and/or nickel using the drug-induced lymphocyte stimulation test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Removal of dental metals containing zinc and/or nickel, combined with lactic acid bacteria probiotics optimized for each participant
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who meet all of the following criteria:
1) Men and women aged 20 to 64
2) Diagnosed with IBS, with symptoms persisting for more than three months and currently present
3) Currently using dental metal materials containing zinc and/or nickel (crowns, bridges, inlays, dentures, etc.)
4) In drug-induced lymphocyte stimulation tests (DLST) using zinc and nickel, at least one Stimulation Index (SI) is greater than 180
5) Agree to replace currently used dental metal materials with non-metal materials (such as lithium disilicate or zirconia ceramics)
6) Able to complete a questionnaire in Japanese
7) Understand the purpose and methods of the study and able to provide written informed consent
Key exclusion criteria
Individuals who meet any of the following criteria:
1) Are currently taking medication on a regular basis
2) Are undergoing treatment for a gastrointestinal disorder
3) Are currently suffering from an acute illness, including an infectious disease
4) Have a history of serious underlying medical conditions (cardiovascular disease, respiratory disease, neuropsychiatric disease, metabolic disease, chronic kidney disease, neoplastic disease, autoimmune disease, infectious disease, etc.)
5) Have a smoking habit
6) Pregnant or breastfeeding women
7) Other cases deemed inappropriate by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nakamura |
Organization
IDO Medical Co., Ltd.
Division name
Chief Scientific Officer
Zip code
140-0002
Address
7F Center Building, Sea Fort Square, 2-3-12 Higashi-shinagawa, Shinagawa-ku, Tokyo
TEL
03-6260-0071
nakamurachibiko@gmail.com
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Ebisui |
Organization
IDO Medical Co., Ltd.
Division name
Secretariat
Zip code
140-0002
Address
7F Center Building, Sea Fort Square, 2-3-12 Higashi-shinagawa, Shinagawa-ku, Tokyo
TEL
03-6260-0071
Homepage URL
ebisui@idou-medical.jp
Sponsor or person
Institute
IDO Medical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Iasokai Takanawa Clinic Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Takanawa Clinic
Address
7F Center Building, Sea Fort Square, 2-3-12 Higashi-shinagawa, Shinagawa-ku, Tokyo
Tel
03-6260-0071
info@idou-medical.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
医療法人社団 癒合会 高輪クリニックグループ（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 14 | 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
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066102
