Clinical Study of PEG Bowel Preparation in Appendectomy Patients

NCT07478029 | Recruiting

• 1 other identifier: TJ-IRB202402126
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is a necessary item of physical examination for colorectal cancer. For high-risk groups, annual physical examination is the most effective way of early prevention; At present, a large amount of polyethylene glycol (PEG2000 - 4000) is often used as laxative and lubricant in colonoscopy. However, the widespread use of PEG may cause long-term and irreversible damage to intestinal microorganisms and bring great hidden dangers to health. The appendix has long been regarded as a redundant organ in evolution. The incidence of appendicitis ranks first in surgical acute abdomen. Traditionally, once acute appendicitis is diagnosed, it is usually treated with appendectomy. However, recent studies have revealed that appendectomy may be associated with psychiatric diseases, colorectal cancer, cardiovascular diseases and other diseases. The appendix is not only an important organ of the immune system, but also undertakes the function of storing and protecting intestinal microbes.. . This change may affect the function of the central nervous system through the microbe gut brain axis, and then pose a potential threat to the health and behavior of the host, such as increasing the risk of diseases such as Parkinson's disease. Based on this, this clinical trial aims to investigate (1) the changes of intestinal flora in the appendectomy population before and after colonoscopy in the process of polyethylene glycol intestinal preparation; (2) the differences between the changes of intestinal flora before and after colonoscopy in the appendicectomy population and the normal population in the process of flora recovery.

Conditions

Appendicitis; Appendicitis Acute

Keywords

Bowel Preparation with Polyethylene Glycol (PEG) Laxatives; Gut microbiota

Outcome Measures

Primary Outcomes (3)

• Change in Relative Abundance of Specific Gut Microbes

  To analyse the changes in relative abundance of specific gut microbes before and after colonoscopy in patients with appendectomy. According to the species abundance table of each species, relative abundance profile display and cluster thermogram display will be carried out. Linear discriminant analysis Effect Size (LEfSe) will be performed using Kruskal-Wallis test and Wilcoxon rank-sum test to identify features with statistically significant differences between groups .

  Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy

• 2.Difference in Gut Microbiota Recovery Trajectory Between Appendectomy and Non-Appendectomy Groups

  To compare the recovery trajectory of the gut microbiota after colonoscopy between patients with appendectomy and control subjects without appendectomy. By comparing the degree of change from baseline in alpha diversity, beta diversity, and relative abundance of specific microbes at 1 month, 3 months, and 6 months post-colonoscopy between the two groups, the role of the appendix in microbiota recovery will be assessed.

  Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy

• 3.Change in Metabolic Function of Gut Microbiota

  To analyse the changes in metabolic function of the gut microbiota before and after colonoscopy in patients with appendectomy. Based on gene annotation results from metagenomic sequencing, the ko gene family will be mapped to the KEGG database to obtain metabolic function annotation information. Differences in the relative abundance of metabolic pathways (e.g., carbohydrate metabolism, short-chain fatty acid synthesis, amino acid metabolism) in fecal microbiota will be compared across time points. Inter-group differences will be analyzed using STAMP software or R packages.

  Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy

Study Arms (2)

Appendectomy Group

Patients with a history of appendectomy or right hemicolectomy (including appendectomy) are recruited. Subjects will undergo colonoscopy as per clinical routine, using PEG laxatives for bowel preparation. Fecal samples will be collected at 5 specific time points (pre-colonoscopy, first non-watery stool post-colonoscopy, 1 month, 3 months, and 6 months post-colonoscopy) for metagenomic sequencing analysis.

Drug: Bowel Preparation with Polyethylene Glycol (PEG) Laxatives

Non-Appendectomy Group

Age-matched healthy controls without a history of appendectomy or right hemicolectomy are recruited. Subjects will undergo colonoscopy as per clinical routine, using PEG laxatives for bowel preparation. Fecal samples will be collected at 5 specific time points (pre-colonoscopy, first non-watery stool post-colonoscopy, 1 month, 3 months, and 6 months post-colonoscopy) for metagenomic sequencing analysis.

Drug: Bowel Preparation with Polyethylene Glycol (PEG) Laxatives

Interventions

Bowel Preparation with Polyethylene Glycol (PEG) Laxatives DRUG

All subjects will undergo bowel preparation by taking Polyethylene Glycol (PEG) electrolyte powder according to the clinical routine requirements for colonoscopy. The specific dosage and administration will follow the hospital's standardized protocol. Researchers will record the usage of PEG.

Appendectomy Group; Non-Appendectomy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research subjects were adult patients from the Department of Gastroenterology of Tongji Hospital in Wuhan, China, who were scheduled to undergo colonoscopy. Participants were recruited continuously from the outpatient department and voluntarily joined after signing a written informed consent form. The participants were divided into two cohorts based on their history of appendectomy: individuals with a history of appendectomy (appendectomy group) and those without an appendectomy (normal group). All participants received routine bowel preparation using polyethylene glycol and provided fecal samples regularly within 6 months. No experimental interventions were conducted.

You may qualify if:

• Aged 18-75 years.
• Scheduled to undergo colonoscopy.
• Generally healthy without major organ diseases.
• For appendectomy group: history of appendectomy or right hemicolectomy (including appendectomy).
• For control group: no history of appendectomy or right hemicolectomy.

You may not qualify if:

• Allergy or intolerance to PEG laxatives.
• Pregnant or lactating women.
• Mental disorders.
• Use of antibiotics within 6 months prior to study enrollment.
• Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency).
• For control group only: presence of organic diseases.

Sponsors & Collaborators

• Huaping Xie: lead

Study Sites (1)

Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (9)

• Ghosh S, Dai C, Brown K, Rajendiran E, Makarenko S, Baker J, Ma C, Halder S, Montero M, Ionescu VA, Klegeris A, Vallance BA, Gibson DL. Colonic microbiota alters host susceptibility to infectious colitis by modulating inflammation, redox status, and ion transporter gene expression. Am J Physiol Gastrointest Liver Physiol. 2011 Jul;301(1):G39-49. doi: 10.1152/ajpgi.00509.2010. Epub 2011 Mar 31.

  PMID: 21454446 BACKGROUND

• Brown K, Abbott DW, Uwiera RRE, Inglis GD. Removal of the cecum affects intestinal fermentation, enteric bacterial community structure, and acute colitis in mice. Gut Microbes. 2018;9(3):218-235. doi: 10.1080/19490976.2017.1408763. Epub 2018 Mar 13.

  PMID: 29227180 BACKGROUND

• Vitetta L, Vitetta G, Hall S. The Brain-Intestinal Mucosa-Appendix- Microbiome-Brain Loop. Diseases. 2018 Apr 1;6(2):23. doi: 10.3390/diseases6020023.

  PMID: 29614774 BACKGROUND

• Nakahara K, Nakane S, Ishii K, Ikeda T, Ando Y. Gut microbiota of Parkinson's disease in an appendectomy cohort: a preliminary study. Sci Rep. 2023 Feb 7;13(1):2210. doi: 10.1038/s41598-023-29219-2.

  PMID: 36750613 BACKGROUND

• Guinane CM, Tadrous A, Fouhy F, Ryan CA, Dempsey EM, Murphy B, Andrews E, Cotter PD, Stanton C, Ross RP. Microbial composition of human appendices from patients following appendectomy. mBio. 2013 Jan 15;4(1):e00366-12. doi: 10.1128/mBio.00366-12.

  PMID: 23322636 BACKGROUND

• Cai S, Fan Y, Zhang B, Lin J, Yang X, Liu Y, Liu J, Ren J, Xu H. Appendectomy Is Associated With Alteration of Human Gut Bacterial and Fungal Communities. Front Microbiol. 2021 Sep 16;12:724980. doi: 10.3389/fmicb.2021.724980. eCollection 2021.

  PMID: 34603252 BACKGROUND

• Girard-Madoux MJH, Gomez de Aguero M, Ganal-Vonarburg SC, Mooser C, Belz GT, Macpherson AJ, Vivier E. The immunological functions of the Appendix: An example of redundancy? Semin Immunol. 2018 Apr;36:31-44. doi: 10.1016/j.smim.2018.02.005. Epub 2018 Mar 2.

  PMID: 29503124 BACKGROUND

• Song MY, Ullah S, Yang HY, Ahmed MR, Saleh AA, Liu BR. Long-term effects of appendectomy in humans: is it the optimal management of appendicitis? Expert Rev Gastroenterol Hepatol. 2021 Jun;15(6):657-664. doi: 10.1080/17474124.2021.1868298. Epub 2021 Jan 4.

  PMID: 33350352 BACKGROUND

• Tropini C, Moss EL, Merrill BD, Ng KM, Higginbottom SK, Casavant EP, Gonzalez CG, Fremin B, Bouley DM, Elias JE, Bhatt AS, Huang KC, Sonnenburg JL. Transient Osmotic Perturbation Causes Long-Term Alteration to the Gut Microbiota. Cell. 2018 Jun 14;173(7):1742-1754.e17. doi: 10.1016/j.cell.2018.05.008.

  PMID: 29906449 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Polyethylene Glycols; Laxatives

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• ping h Xie, Doctor

  Tongji Medical College of Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

ping h Xie

CONTACT

86+13437187007; hpxie@tjh.tjmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 17, 2026
• Study Start: February 23, 2024
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): March 18, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)