Effect of Gastrectomy on Gut Microbiome and Cognitive Function

Recruiting

• Conditions: Gastric Cancer; Perioperative Neurocognitive Disorders
• Interventions: Dietary Supplement: probiotics

• Registration Number: NCT06186089
• Lead Sponsor: Jiangjiang Bi

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-29
• Study Start: 2024-01-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Probiotics (PR)	probiotics	Patients undergoing total gastrectomy take probiotics qd for 3 months after surgery.

Primary Outcome Measures

Name	Time	Method
Cognitive function	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
Composition and diversity of gut microbiota	1 day before surgery and 7 days after surgery	It will be tested by 16s rRNA gene sequencing.

Secondary Outcome Measures

Name	Time	Method
Inflammatory factor	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.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China