Gastric CancerNCT05901779

Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

A study testing live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules in people with Gastric Cancer and Neoadjuvant Chemotherapy, run by The Affiliated Hospital of Qingdao University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gastric Cancer, Neoadjuvant Chemotherapy
What is being tested?: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 318 participants
Where: 1 siteChina
Study dates: 1 Apr 2023to 1 May 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 12Show fewer

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 locations and contacts

1 site in 1 country.

Yanbing Zhou, MD contact

86532-82911324

zhouyanbing@qduhospital.cn

Gan Liu, MD contact

86532-82911324

docliu163@163.com

China1 site, 1 recruiting

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
Zhou Yanbing, 86532-82911324, zhouyanbing@qduhospital.cn
Recruiting

Other trials in China

About this study

Official title: Effect of Perioperative Probiotic Supplements on Postoperative Short-term Outcomes in Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy: A Prospective, Randomized, Controlled, Multicenter Clinical Trial

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.

Conditions: Gastric Cancer, Neoadjuvant Chemotherapy
Being tested: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT05901779
Study group	Role	What they receive
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. Receives: Drug: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules
Control Group	No intervention	CG (Control Group) patients receive blank control management.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up tp 30 days after surgery

Secondary outcomes (14)

postoperative recovery parameter
time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay;
Measured: up tp 30 days after surgery
postoperative death and readmission
postoperative death and readmission within 30 days after surgery
Measured: up tp 30 days after surgery
duration of therapeutic antibiotic use
duration of therapeutic antibiotic use measured as "day"
Measured: up tp 30 days after surgery
time to postoperative adjuvant chemotherapy
durition from surgery to postoperative adjuvant chemotherapy.
Measured: 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)
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.
Measured: on postoperative day 30
Postgastrectomy Syndrome Assessment Scale (PGSAS)-45
Higher score means more discomfort after gastrectomy. The minimum value is 0 and maximum value is 100
Measured: on postoperative day 3, 5, and 30
visual analogue scale
from minimum 0 to maximun 10, higher score means more pain.
Measured: on postoperative day 1, 3 and 5
Leukocyte Count
unit of measurement is "*10^9/L", recorded respectively according to measure time
Measured: Postoperative, on postoperative day 1, 3 and 5
percent of neutrophile granulocyte
unit of measurement is "%", recorded respectively according to measure time
Measured: Postoperative, on postoperative day 1, 3 and 5
procalcitonin
unit of measurement is "pg/ml", recorded respectively according to measure time
Measured: Postoperative, on postoperative day 1, 3 and 5
C-reactive protein
unit of measurement is "mg/L", recorded respectively according to measure time
Measured: Postoperative, on postoperative day 1, 3 and 5
albumin
unit of measurement is "*g/L", recorded respectively according to measure time
Measured: Postoperative, on postoperative day 1, 3 and 5
prealbumin
unit of measurement is "mg/L", recorded respectively according to measure time
Measured: Postoperative, on postoperative day 1, 3 and 5
total bilirubin
unit of measurement is "μmol/L", recorded respectively according to measure time
Measured: Postoperative, on postoperative day 1, 3 and 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20231 May 2024

First posted13 Jun 2023
Study start1 Apr 2023
Primary completion1 Mar 2024 (estimated)
Study completion1 May 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 318 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05901779
Sponsor's protocol ID: GISSG2023-01
Status last verified: Jun 2023
First submitted: 8 May 2023
Last updated: 13 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 40281451

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Perioperative Probiotic Supplements on Postoperative Short-term Outcomes in Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy: A Prospective, Randomized, Controlled, Multicenter Clinical Trial
ClinicalTrials.gov ID: NCT05901779
Acronym / sponsor ID: GISSG2023-01
Conditions: Gastric Cancer, Neoadjuvant Chemotherapy
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 318 participants (estimated)
Lead sponsor: The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
Collaborators: Qilu Hospital of Shandong University, Qianfoshan Hospital, Shandong Provincial Hospital, Yantai Yuhuangding Hospital, Jining First People's Hospital, Weifang Medical University, Weifang People's Hospital, Dongying People's Hospital, Weihai Municipal Hospital, Weihai Central Hospital, Rizhao People's Hospital, Liaocheng People's Hospital, Qingdao Municipal Hospital, The Second Hospital of Shandong University, The People's Hospital of Jimo.Qingdao, Binzhou People's Hospital, Binzhou Medical University, Jinan Central Hospital, Shandong Cancer Hospital and Institute
Study start: 1 Apr 2023 (actual)
Primary completion: 1 Mar 2024 (estimated)
Study completion: 1 May 2024 (estimated)
First posted: 13 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Probiotic Group	Experimental	Drug: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsulesPG (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.
Control Group	No intervention	–CG (Control Group) patients receive blank control management.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
live combined Bifidobacteriun, Lactobacillus and Enterococcus capsulesProbiotics 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.	Drug	Probiotic Group

Primary outcome

postoperative infectious complications
Time frame: up tp 30 days after surgery
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.

14 secondary outcomes

postoperative recovery parameter
Time frame: up tp 30 days after surgery
postoperative death and readmission
Time frame: up tp 30 days after surgery
duration of therapeutic antibiotic use
Time frame: up tp 30 days after surgery
time to postoperative adjuvant chemotherapy
Time frame: 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)
Time frame: on postoperative day 30
Postgastrectomy Syndrome Assessment Scale (PGSAS)-45
Time frame: on postoperative day 3, 5, and 30
visual analogue scale
Time frame: on postoperative day 1, 3 and 5
Leukocyte Count
Time frame: Postoperative, on postoperative day 1, 3 and 5
percent of neutrophile granulocyte
Time frame: Postoperative, on postoperative day 1, 3 and 5
procalcitonin
Time frame: Postoperative, on postoperative day 1, 3 and 5
C-reactive protein
Time frame: Postoperative, on postoperative day 1, 3 and 5
albumin
Time frame: Postoperative, on postoperative day 1, 3 and 5
prealbumin
Time frame: Postoperative, on postoperative day 1, 3 and 5
total bilirubin
Time frame: Postoperative, on postoperative day 1, 3 and 5

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
Derived from this study: PubMed 40281451Liu 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.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yanbing Zhou, MD contact

86532-82911324

zhouyanbing@qduhospital.cn

Gan Liu, MD contact

86532-82911324

docliu163@163.com

Yanbing Zhou, MD study director

The Affiliated Hospital of Qingdao University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanbing Zhou, MD (86532-82911324, zhouyanbing@qduhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative infectious complications (time frame: up tp 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.