Crohn's disease
Conditions
Interventions
Subjects take the study agent (general name: Bifidobacterium, brand name: Biofermin tablet) within the scope of health insurance in Japan. In general, subjects take 6 tablets/day (take 2 tablets for 3
Sponsors
Fukui Hirokazu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are included in this study; 1. Subjects who had participated in the previous study (Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom. / UMIN-CTR No. UMIN000041577) 2. Subjects who were sufferred by abdominal pain or discomfort continuously (three days or more within a month), and who show at least two of the following characteristics. 1) these symptoms were attenuated by defecation 2) defecation frequency was changed accompanied with these symptoms (increased or decreased) 3) fecal properties were changed accompanied with these symptoms (became soft or hard) 3. Patients with CDAI (Crohn's Disease Activity Index) of less than 150 4. Patients with CRP of less than 0.3mg/dL 5. Male and female aged 20 years or older 6. Subjects who give their consent in a written form
Exclusion criteria
Exclusion criteria: Subjects who fall into any of the following criteria are excluded from participating in the study; 1. Subjects who are using any intestinal regulator agents or supplements other than biofermin tablet 2. Subjects with history of myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent 3. Subjects with malignant neoplasm 4. Subjects with history of allergy against Bifidobacterium 5. Subjects with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fecal concentration of calprotectin from baseline to week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change or percent change of the following items from baseline or week 0 to week 4 - Intestinal permeability measured by 24h urine collection - Inflammation biomarkers (IL-1beta, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, IFN-g, MCP-1, MIP-1b, TNF-alfa, REG protein) - Short-chain fatty acid - Blood test (red blood cell count, white blood cell count, hemoglobin, hematocrit, platelet count, HbA1c, fasting plasma glucose, AST, ALT, gamma-GTP, lipid biomarkers (HDL-chol, LDL-chol, T-chol, TG), UA, serum BUN, serum creatinine, eGFRcreat, CRP) - IBS severity index Japanese version - IBS-QOL (Irritable Bowel Syndrome Symptom QOL) Japanese version - CDAI (Crohn's Disease Activity Index) Japanese version - IBS symptoms / GSRS (Gastrointestinal Symptom Rating Scale) Japanese version - Fecal properties / Bristol Scale score - Defecation frequency - SF-8 (Shor Form-8) Japanese version - HADS (Hospital Anxiety and Depression Scale) Japanese version - IBDQ (Inflammatory Bowel Disease Questionnaire) Japanese version - Rome III Japanese version 2. Frequency of adverse event and disease or the like | — |
Contacts
Public ContactToshihiko Tomita
Hyogo Medical University Hospital
Outcome results
None listed