Effect of Gastrectomy on Gut Microbiome and Cognitive Function

April 10, 2024 updated by: Jiangjiang Bi

Effects of Total Gastrectomy or Double Track Reconstruction on Gut Microbiome and Cognitive Function in Patients With Proximal Gastric Cancer

Perioperative neurocognitive disorders is a common postoperative complication in elderly surgical patients. The role of gut microbiota in cognitive function has been concerned in recent years. Studies suggests that gastrointestinal surgery may affect the gut microbiota, and the effect varies between surgical procedures. In this study, the investigators will compare the differences of gut microbiota between total gastrectomy and double-tract reconstruction, to investigate the effect of gastric acid on the gut microbiota colonizing, and the effect of different surgical procedures on the postoperative cognitive function of proximal gastric cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Perioperative neurocognitive disorders is a common postoperative complication in elderly surgical patients, especially in gastrointestinal tumors and cardiac on-pump surgery, and the mechanism is not clear yet. The role of gut microbiota in cognitive function has been concerned in recent years, and the applicant's previous study also found significant differences in the composition of gut microbiota and metabolites in elderly orthopedic surgical patients with postoperative cognitive dysfunction compared with the control group, and that the differential metabolites were mainly enriched in the metabolic pathway of protein digestion and absorption. Studies suggests that gastrointestinal surgery may affect the gut microbiota, and the effect varies between surgical procedures. The incidence of proximal gastric cancer is increasing. In order to prevent severe gastroesophageal reflux, total gastrectomy is mostly performed. However, after total gastrectomy, food directly enters into the intestine, followed by insufficient mixing of gastric acid and food. Patients are prone to nutrient absorption disorders, which may cause changes in gut microbiota. The double-tract reconstruction allows food to enter the distal gastrointestinal tract via two pathways, successfully solving the problems of gastroesophageal reflux, gastroparesis, and long-term nutritional disorders in patients after proximal gastrectomy. In this study, the investigators aim to investigate the effect of gastric acid on the gut microbiota colonizing, and the effect of different surgical procedures on the postoperative cognitive function of proximal gastric cancer patients. The investigators will compare the differences of gut microbiota between total gastrectomy and double-tract reconstruction by 16S ribosomal ribonucleic acid (rRNA) gene sequencing and metabonomics technology, and evaluate the postoperative cognitive function by Mini-mental State Examination scales and Montreal Cognitive Assessment scales.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing proximal gastric cancer surgery with general anesthesia

Description

Inclusion Criteria:

  1. Clinical diagnosis of proximal gastric cancer and will be performed gastrectomy
  2. American Society of Anesthesiologists (ASA) classification I-III
  3. Aged 40-80 years
  4. Perioperative consciousness

Exclusion Criteria:

  1. Central nervous system and psychological disorders
  2. Chronic use of sedatives, antidepressants within the last year
  3. Parkinson's disease
  4. Severe immunosuppression
  5. Severe hearing or vision impairment
  6. Drug dependence; alcoholism
  7. Inability to communicate with a physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Probiotics (PR)
Patients undergoing total gastrectomy take probiotics qd for 3 months after surgery.
Dietary supplement: probiotics
patients undergoing total gastrectomy take probiotics qd for 3 months
Total gastrectomy (TG)
Patients undergoing total gastrectomy
Double-tract reconstruction (DTR)
Patients undergoing double-tract reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: 1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery
The participants will be evaluated by Mini-mental State Examination scales, and diagnosed as cognitive dysfunction if score < 24.
1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery
Cognitive function
Time Frame: 1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery
The participants will be evaluated by Montreal Cognitive Assessment scales, diagnosed as cognitive dysfunction if score < 26
1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery
Composition and diversity of gut microbiota
Time Frame: 1 day before surgery and 7 days after surgery
It will be tested by 16s rRNA gene sequencing.
1 day before surgery and 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory factor
Time Frame: preoperation, 30 minutes and 24 hours after surgery
Interleukin-1β (IL-1β), IL-6, tumor necrosis factor-α (TNF-α), C reactive protein (CRP) will be tested by ELISA kit.
preoperation, 30 minutes and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangjiang Bi

Investigators

  • Principal Investigator: Jiangjiang Bi, MD, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJBi 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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