Depressive symptoms on Ulcerative colitis or Crohn's disease
Conditions
Interventions
Administration of NS Lactobacillus for patients with inflammatory bowel disease with depressive symptoms
Sponsors
Shimodaira Yosuke
NS Bio Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects with inflammatory bowel disease in clinical remission 2)Subjects with depressive symptoms, QIDS-J score of 6 or more and 10 or less and no desire to consult a psychiatrist or psychosomatic physician. 3)20-75 years old at the time of enrollment 4)Subjects who had consent by himself for participation in this study
Exclusion criteria
Exclusion criteria: -Patients who have liver/kidney dysfunction determined by laboratory tests at regular visits (within 3 months). AST, ALT: more than 3 times the upper limit of the reference value. Serum creatinine: more than 1.5 times the upper limit of the reference value -Patients with diabetes mellitus with poor blood sugar control (HbA1c (NGSP)>10.0%). -Patients receiving treatment for chronic lung disease (Obstructive pneumonia, interstitial pneumonia, pulmonary fibrosis, severe emphysema) -Patients with severe heart disease (corresponding to grade III or IV according to NYHA cardiac classification) -Patients who have a comorbid mental illness and have difficulty participating in research. -Patients who have started or changed treatment for depressive symptoms with SSRI, SNRI, NaSSA, tricyclic or tetracyclic antidepressants within the past six months. -Patients with QIDS-J score of 11 points or higher. -Patients taking more than 11 mg of steroids equivalent of prednisolone. -Patients with gastrointestinal stenosis. -Patients who could not consent to the study. -Patients judged inappropriate to attend this study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in QIDS-J score (total score) 3 months after administration in the NS bacteria administration group and the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Effectiveness: -Sleep-related items (items 1-4), appetite/weight-related items (items 6-9), psychomotor status (items 15 and 16) other items (items 5, 10, 11, 12, 13, and 14), in QIDS-J scores at 1,2 and 3 months of administration and rate of change from baseline for the NS bacteria administration group and the placebo group. -Comparison of QIDS-J scores at baseline and 3 months after administration of NS bacteria. -Achievement rate of QIDS-J score of 6 points or less after 3 months of administration of NS. 2 Safety: Summarize the frequency of all adverse events. 3 Others: Questionnaire (free entry) regarding continuation rate of oral medication, reasons for discontinuation, ease of taking. | — |
Contacts
Public ContactYosuke Shimodaira
Akita University Hospital
Outcome results
None listed