Irritable Bowel Symdrome Irritable Bowel Symdrome
Conditions
Interventions
A randomized, placebo-controlled, double-blind, parallel-group study will be conducted
The patients will visit the school after completing the four-week selection process. Upon theri arrival, the researchers will conduct eligibility verification, blood tests, and questionnaire assessmen
Sponsors
Otowa Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Participants who meet the diagnostic criteria for IBS based on the Rome4 criteria and have demonstrated stable and persistent symptoms in two separate GSRS assessments. 2)Males and females aged 20 to 64
Exclusion criteria
Exclusion criteria: 1)Having or a history of cardiovascular disease, liver impairment, renal impairment, blood disorders, or pulmonary disease 2)Currently receiving treatment at a psychiatric or psychosomatic clinic 3)History of severe allergies 4)Suicidal ideation; A score of 2 or higher on item 9 of the BDI 5)Having or a history of organic bowel disease 6)Receiving treatment for IBS 7)Having comorbid dementia or intellectual disability 8)Having diabetes or a history of diabetes 9)Pregnant or possibly pregnant 10)Having a history of severe head trauma or a serious central nervous system disorder 11)Having a pacemaker implanted 12)Having dairy allergy 13)Continuously taking probiotic foods or supplements as well as antibiotics 14)Those who are currently participating in other clinical trials 15)Determined by the principal investigator or co-investigator to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in IBS symptoms: results of a questionnaire survey (IBSSI-J) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the following observations, surveys, and laboratory tests: mean activity level, results of questionnaires (IBS-QOL-J, GSRS, BDI-2, Athens insomnia scale, STAI), results of blood tests (inflammation markers, cortisol), intestinal microflora bacteria count (Bifidobacterium bacteria count measured by quantitative PCR method), intestinal environment (organic acids in feces ) | — |
Contacts
Public ContactHanami Kojima
Teikyo University
Outcome results
None listed