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Perioperative Neurocognitive DisordersNCT06186089

Effect of Gastrectomy on Gut Microbiome and Cognitive Function

An observational study of Perioperative Neurocognitive Disorders and Gastric Cancer, run by Jiangjiang Bi 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
probiotics
How many people
45 participants
Where
1 siteChina
Study dates
20 Jan 2024to Jun 2026
Phase
Observational
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing proximal gastric cancer surgery with general anesthesia

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jiangjiang Bi, MD contact

862783665431

bessie8210@163.com

China1 site, 1 recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430030

    Jiangjiang Bi, +862783665431, bessie8210@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
probiotics
Keywords
Perioperative neurocognitive disorders, proximal gastric cancer, gut microbiota, double-tract reconstruction
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • probioticsDietary supplement

    patients undergoing total gastrectomy take probiotics qd for 3 months

Study groups in NCT06186089
Study groupRoleWhat they receive
Probiotics (PR)Patients undergoing total gastrectomy take probiotics qd for 3 months after surgery.
Receives: Dietary Supplement: probiotics
Total gastrectomy (TG)Patients undergoing total gastrectomy
Double-tract reconstruction (DTR)Patients undergoing double-tract reconstruction

What is being measured

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

  1. Cognitive function

    The participants will be evaluated by Mini-mental State Examination scales, and diagnosed as cognitive dysfunction if score < 24.

    Measured: 1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery

  2. Cognitive function

    The participants will be evaluated by Montreal Cognitive Assessment scales, diagnosed as cognitive dysfunction if score < 26

    Measured: 1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery

  3. Composition and diversity of gut microbiota

    It will be tested by 16s rRNA gene sequencing.

    Measured: 1 day before surgery and 7 days after surgery

Secondary outcomes (1)

  1. Inflammatory factor

    Interleukin-1β (IL-1β), IL-6, tumor necrosis factor-α (TNF-α), C reactive protein (CRP) will be tested by ELISA kit.

    Measured: preoperation, 30 minutes and 24 hours after surgery

Timeline

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

  1. First posted29 Dec 2023
  2. Study start20 Jan 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06186089
Sponsor's protocol ID
JJBi 2023
Status last verified
Apr 2024
First submitted
7 Dec 2023
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30325806

  • 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.

    PubMed 24059313

  • 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.

    PubMed 26457021

  • 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.

    PubMed 36875700

  • 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.

    PubMed 29886457

  • 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.

    PubMed 34354801

  • 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.

    PubMed 28279578

  • 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.

    PubMed 31953253

  • 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.

    PubMed 26481855

  • 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.

    PubMed 31684843

  • 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.

    PubMed 30066368

  • 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.

    PubMed 30023410

Questions about this trial

What is this clinical trial studying?

An observational study of Perioperative Neurocognitive Disorders and Gastric Cancer, run by Jiangjiang Bi at 1 site in China.

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 4 inclusion and 7 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 11 Apr 2024. 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 Jiangjiang Bi, MD (862783665431, bessie8210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive function (time frame: 1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery). The study lists 3 primary outcomes in all. 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 NCT06186089, which also lists 12 linked publications.

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 11 Apr 2024.

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