Irritable bowel syndrome
Conditions
Interventions
Removal of dental metals containing zinc and/or nickel, combined with lactic acid bacteria probiotics optimized for each participant
Sponsors
IDO Medical Co., Ltd.
Medical Corporation Iasokai Takanawa Clinic Group
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS severity index (IBS-SI) Participants' IBS symptoms will be assessed using a self-administered IBS-SI questionnaire before and after dental metal removal. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomoka Ebisui
IDO Medical Co., Ltd. Secretariat
Outcome results
None listed