Effect of Gastrectomy on Gut Microbiome and Cognitive Function

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186089
• Other study ID #: JJBi 2023
• Status: Recruiting
• Start date: January 20, 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: Jiangjiang Bi, MD
• Phone: 862783665431
• Email: bessie8210[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Neurocognitive Disorders
• Stomach Neoplasms

Intervention

Dietary Supplement:
• probiotics
patients undergoing total gastrectomy take probiotics qd for 3 months

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangjiang Bi

Country where clinical trial is conducted

China, 

References & Publications (12)

Bi J, Xu Y, Li S, Zhan G, Hua D, Tan J, Chi X, Xiang H, Guo F, Luo A. Contribution of preoperative gut microbiota in postoperative neurocognitive dysfunction in elderly patients undergoing orthopedic surgery. Front Aging Neurosci. 2023 Feb 17;15:1108205. doi: 10.3389/fnagi.2023.1108205. eCollection 2023. — View Citation

Bianchi VE, Herrera PF, Laura R. Effect of nutrition on neurodegenerative diseases. A systematic review. Nutr Neurosci. 2021 Oct;24(10):810-834. doi: 10.1080/1028415X.2019.1681088. Epub 2019 Nov 4. — View Citation

Cavin JB, Couvelard A, Lebtahi R, Ducroc R, Arapis K, Voitellier E, Cluzeaud F, Gillard L, Hourseau M, Mikail N, Ribeiro-Parenti L, Kapel N, Marmuse JP, Bado A, Le Gall M. Differences in Alimentary Glucose Absorption and Intestinal Disposal of Blood Glucose After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy. Gastroenterology. 2016 Feb;150(2):454-64.e9. doi: 10.1053/j.gastro.2015.10.009. Epub 2015 Oct 23. — View Citation

Erawijantari PP, Mizutani S, Shiroma H, Shiba S, Nakajima T, Sakamoto T, Saito Y, Fukuda S, Yachida S, Yamada T. Influence of gastrectomy for gastric cancer treatment on faecal microbiome and metabolome profiles. Gut. 2020 Aug;69(8):1404-1415. doi: 10.1136/gutjnl-2019-319188. Epub 2020 Jan 16. — View Citation

Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the Nomenclature of Cognitive Change Associated with Anaesthesia and Surgery-2018. Anesthesiology. 2018 Nov;129(5):872-879. doi: 10.1097/ALN.0000000000002334. — View Citation

Jahansouz C, Staley C, Bernlohr DA, Sadowsky MJ, Khoruts A, Ikramuddin S. Sleeve gastrectomy drives persistent shifts in the gut microbiome. Surg Obes Relat Dis. 2017 Jun;13(6):916-924. doi: 10.1016/j.soard.2017.01.003. Epub 2017 Jan 4. — View Citation

Maksimaityte V, Bausys A, Kryzauskas M, Luksta M, Stundiene I, Bickaite K, Bausys B, Poskus T, Bausys R, Strupas K. Gastrectomy impact on the gut microbiome in patients with gastric cancer: A comprehensive review. World J Gastrointest Surg. 2021 Jul 27;13(7):678-688. doi: 10.4240/wjgs.v13.i7.678. — View Citation

Martin CR, Osadchiy V, Kalani A, Mayer EA. The Brain-Gut-Microbiome Axis. Cell Mol Gastroenterol Hepatol. 2018 Apr 12;6(2):133-148. doi: 10.1016/j.jcmgh.2018.04.003. eCollection 2018. — View Citation

Mulak A, Bonaz B. Brain-gut-microbiota axis in Parkinson's disease. World J Gastroenterol. 2015 Oct 7;21(37):10609-20. doi: 10.3748/wjg.v21.i37.10609. — View Citation

Naseer MI, Bibi F, Alqahtani MH, Chaudhary AG, Azhar EI, Kamal MA, Yasir M. Role of gut microbiota in obesity, type 2 diabetes and Alzheimer's disease. CNS Neurol Disord Drug Targets. 2014 Mar;13(2):305-11. doi: 10.2174/18715273113126660147. — View Citation

van de Wouw M, Boehme M, Lyte JM, Wiley N, Strain C, O'Sullivan O, Clarke G, Stanton C, Dinan TG, Cryan JF. Short-chain fatty acids: microbial metabolites that alleviate stress-induced brain-gut axis alterations. J Physiol. 2018 Oct;596(20):4923-4944. doi: 10.1113/JP276431. Epub 2018 Aug 28. — View Citation

Zhan G, Yang N, Li S, Huang N, Fang X, Zhang J, Zhu B, Yang L, Yang C, Luo A. Abnormal gut microbiota composition contributes to cognitive dysfunction in SAMP8 mice. Aging (Albany NY). 2018 Jun 10;10(6):1257-1267. doi: 10.18632/aging.101464. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	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
Primary	Cognitive function	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
Primary	Composition and diversity of gut microbiota	It will be tested by 16s rRNA gene sequencing.	1 day before surgery and 7 days after surgery
Secondary	Inflammatory factor	Interleukin-1ß (IL-1ß), IL-6, tumor necrosis factor-a (TNF-a), C reactive protein (CRP) will be tested by ELISA kit.	preoperation, 30 minutes and 24 hours after surgery