NCT05901779

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
318

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 8, 2023

Last Update Submit

June 4, 2023

Conditions

Gastric CancerNeoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • postoperative infectious complications

    The primary outcome was the incidence of postoperative infectious complications, which were defined as bacterial infections within 30 d after surgery. The diagnosis of infectious complications was based on fever (≥38°C), elevation of C-reactive protein (CRP), specific clinical symptoms of infection, and positive bacterial culture.

    up tp 30 days after surgery

Secondary Outcomes (14)

  • postoperative recovery parameter

    up tp 30 days after surgery

  • postoperative death and readmission

    up tp 30 days after surgery

  • duration of therapeutic antibiotic use

    up tp 30 days after surgery

  • time to postoperative adjuvant chemotherapy

    up tp 30 days after surgery

  • European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 (EORTC QLQ-C30) (V3.0)

    on postoperative day 30

  • +9 more secondary outcomes

Study Arms (2)

Probiotic Group

EXPERIMENTAL

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.

Drug: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules

Control Group

NO INTERVENTION

CG (Control Group) patients receive blank control management.

Interventions

live combined Bifidobacteriun, Lactobacillus and Enterococcus capsulesDRUG

Probiotics capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. Each capsule contained\>10,000,000 colony-forming units (CFUs). This drug can treat endoxemia caused by imbalance of intestinal flora.

Probiotic Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

RECRUITING

Related Publications (1)

  • Liu G, Cao S, Liu X, Tian Y, Yu W, Chai J, Li L, Wang X, Chu X, Duan Q, Qu J, Wang H, Zhang H, Wang X, Hui X, Yang D, Zhou S, Ding Y, Wang H, Zhou F, Hu B, Guo P, Jiang L, Zhang G, Pan Q, Zhou X, Zhou Y. Effect of perioperative probiotic supplements on the short-term clinical outcomes of patients undergoing laparoscopic or robotic radical gastrectomy after neoadjuvant chemotherapy: Study protocol for a multicenter randomized controlled trial (GISSG2023 - 01 Study). BMC Cancer. 2025 Apr 25;25(1):776. doi: 10.1186/s12885-025-14115-x.

    PMID: 40281451DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yanbing Zhou, MD

    The Affiliated Hospital of Qingdao University

    STUDY DIRECTOR

Central Study Contacts

Yanbing Zhou, MD

CONTACT

86532-82911324zhouyanbing@qduhospital.cn

Gan Liu, MD

CONTACT

86532-82911324docliu163@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2023

First Posted

June 13, 2023

Study Start

April 1, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN(1)