Study on the effect of a nutritional supplement on intestinal microbiota and nutritional status of chronic kidney disease patients.

UMIN ID: UMIN000056197

Registered date:19/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 2024/11/20
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Taking orally one pack of nutritional supplement (150 kcal) per day for 6 weeks

Outcome(s)

• Primary Outcome: Stool-related indicators (fecal microbiota, organic acids, putrefactive products, pH), defecation habits (frequency, number of days, and type of shape), body weight, clinical laboratory indicators (hematological and blood biochemical indicators)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Persons who regularly use antibiotics or active biologic agents (2) Persons who regularly use health foods or supplements that improve bowel movements (lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber, etc.) (3) Persons with a history of gastrointestinal resection (3) Persons with a history of gastrointestinal resection (4) Persons who have allergic symptoms due to intake of milk or soy-derived ingredients (5) Persons who experience abdominal symptoms such as diarrhea upon ingestion of dairy products (6) Persons who are participating in other clinical trials (7) Persons who are judged to be unsuitable as subjects by the study director due to subject background, lifestyle, etc.

Related Information

• Primary Sponsor: Bousei Nishi-Shinjuku Clinic
• Source(s) of Monetary Support: Morinaga Milk Industry Co., Ltd.