Clinical study on changes in gut microbiota and the effect of bifidobacterium administration in postoperative patients with esophageal cancer

UMIN ID: UMIN000048189

Registered date:29/06/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: esophageal cancer
• Date of first enrollment: 2022/06/29
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): One sachet of bifidobacterium powder is administered in the evening of the first postoperative day. From the second to the seventh postoperative day, One sachet of bifidobacterium powder is administered three times a day.

Outcome(s)

• Primary Outcome: abundance of proteobacteria in feces
• Secondary Outcome: 1) Species and diversity score of gut microbiota 2) Gastrointestinal symptoms after surgery 3) Frequency and severity of infectious complications 4) Frequency and severity of other postoperative complications 5) Length of hospital stay after surgery 6) Nutritional intake 7) Blood test

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with Performance Status of 3 or higher 2) Patients with serious complications such as poorly controlled diabetes mellitus or hypertension 3) Patients with muscle diseases including active myopathy or muscular dystrophy 4) Patients who are pregnant or lactating 5) Patients who participated in clinical trial or clinical research involving the use of an unapproved drug and received an investigational drug or unapproved drug at least 16 weeks prior to the informed consent 6) Patients who are determined to be ineligible for this study by the principal investigator or subinvestigator 7) Patients who are allergic to the study food 8) Patients who failed to obtain informed consent or withdrew informed consent

Related Information

• Primary Sponsor: Nagoya City University Graduate School of Medical Sciences
• Source(s) of Monetary Support: Clinico Co., Ltd.