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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05901779
Other study ID # GISSG2023-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date May 1, 2024

Study information

Verified date June 2023
Source The Affiliated Hospital of Qingdao University
Contact Yanbing Zhou, MD
Phone 86532-82911324
Email zhouyanbing@qduhospital.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 318
Est. completion date May 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 ?~? - 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>?, 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

Study Design


Intervention

Drug:
live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules
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.

Locations

Country Name City State
China Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital Qingdao Shandong

Sponsors (20)

Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University Binzhou Medical University, Binzhou People's Hospital, Dongying People's Hospital, Jinan Central Hospital, Liaocheng People's Hospital, Qianfoshan Hospital, Qilu Hospital of Shandong University, Qingdao Municipal Hospital, Rizhao People's Hospital, Shandong Cancer Hospital and Institute, Shandong Jining No.1 People's Hospital, Shandong Provincial Hospital, The People's Hospital of Jimo.Qingdao, The Second Hospital of Shandong University, Weifang Medical University, Weifang People's Hospital, Weihai Central Hospital, Weihai Municipal Hospital, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 postoperative recovery parameter time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay; up tp 30 days after surgery
Secondary postoperative death and readmission postoperative death and readmission within 30 days after surgery up tp 30 days after surgery
Secondary duration of therapeutic antibiotic use duration of therapeutic antibiotic use measured as "day" up tp 30 days after surgery
Secondary time to postoperative adjuvant chemotherapy durition from surgery to postoperative adjuvant chemotherapy. up tp 30 days after surgery
Secondary European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 (EORTC QLQ-C30) (V3.0) The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30, Higher scores for functional areas and general health indicate better functional status and quality of life, and higher scores for symptom areas indicate more symptoms or medical problems. The minimum value is 0 and maximum value is 100. on postoperative day 30
Secondary Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 Higher score means more discomfort after gastrectomy. The minimum value is 0 and maximum value is 100 on postoperative day 3, 5, and 30
Secondary visual analogue scale from minimum 0 to maximun 10, higher score means more pain. on postoperative day 1, 3 and 5
Secondary Leukocyte Count unit of measurement is "*10^9/L", recorded respectively according to measure time Postoperative, on postoperative day 1, 3 and 5
Secondary percent of neutrophile granulocyte unit of measurement is "%", recorded respectively according to measure time Postoperative, on postoperative day 1, 3 and 5
Secondary procalcitonin unit of measurement is "pg/ml", recorded respectively according to measure time Postoperative, on postoperative day 1, 3 and 5
Secondary C-reactive protein unit of measurement is "mg/L", recorded respectively according to measure time Postoperative, on postoperative day 1, 3 and 5
Secondary albumin unit of measurement is "*g/L", recorded respectively according to measure time Postoperative, on postoperative day 1, 3 and 5
Secondary prealbumin unit of measurement is "mg/L", recorded respectively according to measure time Postoperative, on postoperative day 1, 3 and 5
Secondary total bilirubin unit of measurement is "µmol/L", recorded respectively according to measure time Postoperative, on postoperative day 1, 3 and 5
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