Prevention of Postoperative Infections after Lung Resection with Probiotics

JRCT ID: jRCTs061230048

Registered date:16/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Postoperative infections after lung resection
• Date of first enrollment: 13/09/2023
• Target sample size: 700
• Study type: Interventional
• Intervention(s): Miya BM, a daily dose of 3 g, divided into 3 times a day, administered orally after meals

Outcome(s)

• Primary Outcome: All postoperative infections including surgical site infections (SSIs)
• Secondary Outcome: Occurrence of adverse events due to Miya BM, all postoperative complications excluding postoperative infections after lung resection (CTCAE v5.0-JCOG grade2 and more), chest tube duration, hospital duration, body temperature and body weight, blood test (white blood cell count, white blood cell differential, CRP, serum albumin level, serum total cholesterol level, serum cholinesterase level)

Key inclusion & exclusion criteria

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

Include criteria

(1) Outpatients or hospitalized patients scheduled for thoracoscopic anatomical lung resection (lobectomy or segmentectomy) for pulmonary lesions
(2) Patients suspected of primary lung cancer by CT or PET-CT, or diagnosed with primary lung cancer by bronchoscopy or CT-guided biopsy
(3) Patients aged 20 years or older at the time of informed consent
(4) Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study

Exclude criteria

(1) Patients with a history of allergy to probiotics
(2) Patients with a history of side effects due to oral administration of probiotics
(3) Patients who have already received continuous administration of probiotics
(4) Patients who are currently taking probiotics regularly as guidance-required or over-the-counter drugs
(5) Patients undergoing treatment for any infectious disease

Related Information

• Primary Sponsor: Hamano Kimikazu
• Secondary Sponsor: Murakami Junichi
• Source(s) of Monetary Support: Takeda Science Foundation