Effect of Gastrectomy on Gut Microbiome and Cognitive Function

NCT06186089 | Recruiting

• 1 other identifier: JJBi 2023
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Neurocognitive Disorders; Gastric Cancer

Keywords

Perioperative neurocognitive disorders; proximal gastric cancer; gut microbiota; double-tract reconstruction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Inflammatory factor

  preoperation, 30 minutes and 24 hours after surgery

Study Arms (3)

Probiotics (PR)

Patients undergoing total gastrectomy take probiotics qd for 3 months after surgery.

Dietary Supplement: probiotics

Total gastrectomy (TG)

Patients undergoing total gastrectomy

Double-tract reconstruction (DTR)

Patients undergoing double-tract reconstruction

Interventions

probiotics DIETARY_SUPPLEMENT

patients undergoing total gastrectomy take probiotics qd for 3 months

Probiotics (PR)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing proximal gastric cancer surgery with general anesthesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangjiang Bi: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 30325806 BACKGROUND

• 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.

  PMID: 24059313 BACKGROUND

• 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.

  PMID: 26457021 BACKGROUND

• 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.

  PMID: 36875700 BACKGROUND

• 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.

  PMID: 29886457 BACKGROUND

• 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.

  PMID: 34354801 BACKGROUND

• 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.

  PMID: 28279578 BACKGROUND

• 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.

  PMID: 31953253 BACKGROUND

• 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.

  PMID: 26481855 BACKGROUND

• 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.

  PMID: 31684843 BACKGROUND

• 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.

  PMID: 30066368 BACKGROUND

• 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.

  PMID: 30023410 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Faeces and Peripheral Blood

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jiangjiang Bi, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiangjiang Bi, MD

CONTACT

862783665431; bessie8210@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 29, 2023
• Study Start: January 20, 2024
• Primary Completion: December 1, 2025
• Study Completion: June 1, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)