Phase II study to evaluate the Synbiotics efficacy on reducing the incidence of postoperative infectious complications after liver resection.

JRCT ID: jRCTs031240051

Registered date:25/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with primary biliary tract cancer without distant metastases(with/without tissue diagnosis)
• Date of first enrollment: 05/07/2024
• Target sample size: 254
• Study type: Interventional

Intervention(s)

Control group:
One packet each of probiotic placebo and prebiotic placebo (two packets in total) three times a day daily during the following periods: From 14 days before hepatectomy to the day before surgery, and from the day after hepatectomy to 14 days after surgery.

Test group:
One pachet each of food containing lactobacilli and bifidobacteria as probiotics and oligosaccharide food as prebiotics (synbiotic therapy) (two packets in total) three times a day daily during the following periods: From 14 days before hepatectomy to the day before surgery, and from the day after hepatectomy to 14 days after surgery.

Outcome(s)

• Primary Outcome: Incidence of post-operative infectious complications
• Secondary Outcome: Surgical mortality, Number of days on antimicrobials, Number of postoperative hospital days, Incidence of pre-operative cholangitis, Detection of bacteria in blood, Intestinal microbiota, Intestinal organic acid concentration ,Detection of bacteria in tumor tissue, Detection of bacteria in bile, Detection of bacteria in drainage fluid, Incidence of liver failure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Patients aged between 20 and 80 years at the time of enrolment.
2) Patients diagnosed with primary biliary tract cancer without distant metastasis.
3) Patients with a general health status (ECOG PS) of 0-1.
4) Patients with no previous treatment for biliary tract cancer prior to enrolment.
5) Patients scheduled for hepatic resection beyond the hepatic lobectomy with biliary reconstruction.
6) Patients who give written free and voluntary consent to participate in the study.

Exclude criteria

1) Patients who have taken other probiotics, synbiotic products and other antiflatulent, including supplements, in the seven days prior to obtaining consent, and who have are unable to discontinue taking other probiotics, synbiotic products and other antiflatulent, including supplements, from the date of obtaining consent until the end of the postoperative infectious complication assessment.
2) Patients who are unable to consume the study products
3) Patients who have already participated or will participate during the study period in other clinical trials or clinical studies
4) Patients who are judged to be unsuitable as subjects by the principal investigator or research assistant.

Related Information

• Primary Sponsor: Matsuyama Ryusei
• Secondary Sponsor: Endo Itaru
• Source(s) of Monetary Support: Yakult Honsha Co.,Ltd.