Probiotics trial

JRCT ID: jRCTs031200004

Registered date:06/04/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 20/05/2020
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Probiotic administration group: Bifidobacterial powder BB536 (Morinaga Milk Industry Group, Pathology and Nutrition Division Clinico Co., Ltd.) is administered orally as probiotics for 2 weeks before surgery and 3 months after surgery (resumed from the third day after surgery).
Probiotics non-administration group: Bifidobacterial powder BB536 is not administered orally

Outcome(s)

• Primary Outcome: Body weight and skeletal muscle mass

Secondary Outcome

1)Enterobacterial flora
2)Postoperative complication rate
3)Abdominal symptom

Key inclusion & exclusion criteria

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

Include criteria

1)Patients who are histologically diagnosed as gastric adenocarcinoma, and scheduled to perform gastrectomy
2)Patients with gastric cancer who are unlikely to be treated with anticancer drugs after surgery
3)Clinical stage
a)T1-3
b)N0-1
c)M0
4)Regardless of whether the operation is open or laparoscopic
5) Main organ function is maintained
6) Patients who gave written informed consent before entry in this study

Exclude criteria

1)Milk ingredient allergy
2)Double cancer
3)Infectious disease with systemic treatment
4)Pregnant or breast feeding.
5)BMI, more than 30
6)Cases judged by the attending physician as ineligible

Related Information

• Primary Sponsor: Yamamoto Soichiro
• Secondary Sponsor: Morinaga Milk Industry CO., LTD
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO., LTD.