The effect of lactosucrose in patients with depression

JRCT ID: jRCTs051180163

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Depressive episode in ICD-10
• Date of first enrollment: 10/07/2018
• Target sample size: 20
• Study type: Interventional

Intervention(s)

1. Eating probiotics (Lactosucrose)
2. Nutritional education once a month

Outcome(s)

• Primary Outcome: Total MADRS score improvement

Secondary Outcome

Changes in following parameters six months after the start of intervention.
1. Body data, 2. Blood data, 3. Mood symptoms, 4. Self-efficacy, 5. QOL, 6. intestinal flora, 7. content of fat and carbohydrate in feces, 8. frequency of stool and fecal characteristics, 9. dietary intake and 10. medication adherence.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Outpatients with depression (ICD-10: F32) treated at Osaka Institute of Clinical Psychiatry, Shin-Abuyama Hospital.
2. Subjects who had some mood symptoms between 2 to 5 in CGI-S (Clinical Global Impression-Severity Scale).

Exclude criteria

1. subjects who do not accept the informed consent.
2. subjects who routinely take probiotics or probiotics.
3. Subjects who had dementia.
4. Subjects who had mental retardation.
5. Subjects who had inflammatory bowel disease like ulcerative colitis or Crohn's disease.
6. Subjects who had history of taking antibiotics within two weeks of consent acquisition.
7. Subjects who had history of diarrhea within two weeks of consent acquisition.

Related Information

• Primary Sponsor: Tarutani Seiichiro
• Secondary Sponsor: Ido Yumiko,Osaka Institute of Clinical Psychiatry,BAIKA Women's University,Doshisha Women's College
• Secondary ID(s): UMIN000030973