The effect of NS Lactobacillus on depressive symptoms on inflammatory bowel disease patients

JRCT ID: jRCTs021240056

Registered date:27/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Depressive symptoms on Ulcerative colitis or Crohn's disease
• Date of first enrollment: 27/01/2025
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Administration of NS Lactobacillus for patients with inflammatory bowel disease with depressive symptoms

Outcome(s)

• Primary Outcome: Rate of change in QIDS-J score (total score) 3 months after administration in the NS bacteria administration group and the placebo group.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Shimodaira Yosuke
• Secondary Sponsor: NS Bio Japan