Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

Qingdao University

Status: Enrolling

Conditions: Gastric Cancer; Neoadjuvant Chemotherapy

Treatments: Drug: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05901779

GISSG2023-01

Details and patient eligibility

About

Background: Surgery can significantly improve the prognosis of patients with gastric cancer. However, some patients are at a later stage at diagnosis and need to receive neoadjuvant chemotherapy (NACT). Previous studies have shown that NACT may lead to more postoperative complications. Probiotics have the potential to reduce postoperative complications and infections, but no large sample, multicentre, randomized clinical trials have been conducted in patients with gastric cancer receiving NACT. The aim of this multicentre randomized controlled trial was to investigate the effect of probiotics on postoperative infections and other short-term outcomes in patients with gastric cancer receiving NACT.

Methods/design: This study is a prospective, multicentre RCT. This experiment will consist of two groups - an experimental group and a control group - randomly divided in a 1:1 ratio. The experimental group will receive perioperative probiotic supplement and that of the control group will receive blank control management. An estimated 318 patients will be enrolled. The main endpoint for comparison is postoperative infections between the two groups.The experimental group patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis.

Enrollment: 318 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years old
• male and female
• clinical stage was T3/4N+ evaluated by CT/MR/EUS at new diagnosis (before any anti-cancer treatment) , complete 2-4 cycles preoperative chemotherapy based on 5-FU (such as SOX, FLOX, ect.) at 3-6 weeks before surgery
• ASA grade was Ⅰ~Ⅲ
• radical minimal-invasive gastrectomy via laparoscope or DaVinci is judged as possible
• histologically confirmed gastric adenocarcinoma
• ECOG score is 0~1
• patients who provide a written informed consent before entering study screening

Exclusion criteria

• need emergency surgery due to performation and/or obstruction
• receive antibiotics and/or glucocorticoids within 14 days before surgery
• exist bacterial infection and/or autoimmune disease and/or IBD currently
• intolerance or allergic to probiotics
• upper abdominal surgery history
• use probiotics within 7 days before intervention, such as yogurt, ect.
• participate in other clinical trials currently
• severe mental illness
• can not participate in this trial due to severe illness of other organs evaluated by researchers, such as severe cardiac insufficiency (LVEF<30%, NYHA>Ⅱ, severe arrhythmia, congestive heart failure, myocardial infarction within 6 months), liver dysfunction (Child-Pugh C), renal dysfunction (need hemodialysis)
• need simultaneous surgery
• lactation or pregnancy
• refuse to participate in this trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

318 participants in 2 patient groups

Probiotic Group

Experimental group

Description:

PG (probiotic group) patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. The intervention begins from the completion of preoperative chemotherapy to the seventh day after surgery.

Treatment:

Drug: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules

Control Group

No Intervention group

Description:

CG (Control Group) patients receive blank control management.