AppendicitisNCT07478029
Clinical Study of PEG Bowel Preparation in Appendectomy Patients
An observational study of Appendicitis and Appendicitis Acute, run by Huaping Xie at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis, Appendicitis Acute
- What is being tested?
- Bowel Preparation with Polyethylene Glycol (PEG) Laxatives
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2024to 18 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology
Wuhan, Hubei, 430030
ping h Xie, 86+13437187007, hpxie@tjh.tjmu.edu.cn
About this study
Official title: Impact of Polyethylene Glycol (PEG) Bowel Preparation on Intestinal Microbiota Composition and Diversity in Patients Undergoing Appendectomy
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.
Read the detailed description
The human gut microbiota constitutes one of the densest microbial communities on Earth, encompassing a highly diverse assembly of microorganisms that perform metabolic, immune, and protective functions crucial to human health. The gastrointestinal microbiota is influenced by a variety of factors, including genetics, host physiological status (such as age, disease, and stress), and environmental conditions such as living environment and medication use. Among these numerous perturbing factors, iatrogenic interventions-particularly the bowel cleansing procedure essential before colonoscopy-exert a particularly significant impact on the gut microecosystem.
Current colonoscopy preparation involves the administration of large volumes of polyethylene glycol (PEG2000-4000) as a laxative and lubricant. Existing studies indicate that PEG use may markedly reduce microbial richness and diversity. Specifically, PEG ingestion can lead to aberrant proliferation of *Akkermansia* species, a reduction in Firmicutes, and an increased load and virulence gene expression of pathogens such as *Citrobacter*. Metabolically, PEG use may result in decreased dehydroxylation of primary bile acids and altered cholesterol metabolism, ultimately contributing to diarrhea, weight loss, disruption of lipid and energy metabolism, and intestinal inflammation. Thus, extensive use of PEG may cause long-term and irreversible damage to the gut microbiota, posing substantial risks to health.
The appendix, located at the base of the cecum, is an elongated, tubular structure protruding from the posterior wall of the cecum. As an integral component of the intestinal mucosal immune system, its lumen harbors rich biofilm structures that provide an "ecological sanctuary" for commensal bacteria, shielding them from the flushing effect of intestinal contents. Emerging research indicates that under physiological conditions, the appendix continuously receives and shelters specific microbiota from the proximal colon, particularly adherent members of the Firmicutes and Bacteroidetes phyla. When microbial dysbiosis occurs in the host-due to factors such as infection, antibiotic exposure, or bowel cleansing-the appendix can serve as a microbial reservoir, accelerating the process of microecological restoration. Therefore, the appendix is considered a "natural backup system" for the gut microbiota, and its integrity plays an irreplaceable role in resisting microbial disturbances and maintaining microecological resilience. Historically, appendicitis has ranked as the most common acute abdominal emergency, and once acute appendicitis occurs, traditional therapy often involves appendectomy. Extensive epidemiological evidence has shown that post-appendectomy populations have significantly elevated risks of *Clostridioides difficile* infection, colorectal cancer, Parkinson's disease, and depression. Metagenomic studies further reveal that appendectomized individuals exhibit reduced gut microbial diversity, persistently low abundance of short-chain fatty acid-producing genera (e.g., *Faecalibacterium* and *Roseburia*), diminished stability of microbial networks, and compromised resistance and resilience against external disturbances. These findings suggest that appendiceal loss may place the gut microecosystem in a state of "fragile equilibrium," wherein superimposing the strong perturbation of PEG-based bowel cleansing could induce more severe and persistent dysbiosis.
This study adopts a parallel-controlled, monitored clinical trial design, enrolling a total of approximately 10 participants. Eligible subjects must have previously undergone appendectomy or right hemicolectomy with appendectomy, be aged 18-75 years, be scheduled for colonoscopy, be generally healthy, and have no history of major organ diseases. Control subjects must be aged 18-75 years, have no history of appendectomy or right hemicolectomy with appendectomy, be generally healthy, and have no history of major organ diseases. Both groups must meet corresponding exclusion criteria, including: contraindications to colonoscopy (e.g., organic diseases such as cardiopulmonary insufficiency), inability to tolerate PEG laxatives, pregnancy, long-standing history of intestinal diseases, or antibiotic use within the past six months.
Fecal samples will be collected at multiple time points: before colonoscopy, at the first non-watery stool after colonoscopy, and at one month, three months, and six months post-colonoscopy. Metagenomic sequencing will be used to detect fecal gut microbial information, and bioinformatics analysis will be performed with a focus on: (1) the long-term effects of colonoscopy on the gut microbiota and the disturbance characteristics during gut microecological recovery following appendectomy; (2) designing microecological restoration probiotic formulations based on microbiome features; and (3) screening representative fecal samples for subsequent animal experiments.
This study will not use recruitment advertisements; participation is entirely voluntary. Subjects will be informed of potential risks during the experiment and will sign informed consent forms upon agreeing to join the study. Volunteers who consent to participate will complete a questionnaire to assess their intestinal health status and other health conditions and will be screened according to the aforementioned selection and exclusion criteria. Collected samples will be labeled with codes to ensure that no personally identifiable information is disclosed. Throughout the study, participants' identities will be kept confidential, with only codes and disease phenotypes visible. Subjects may withdraw from the study at any time.
This study will analyze the composition and structure of participants' gut microbiota, and subjects will be kept informed of the progress of the tests and analyses in a timely manner and will have access to their own relevant data.
- Conditions
- Appendicitis, Appendicitis Acute
- Being tested
- Bowel Preparation with Polyethylene Glycol (PEG) Laxatives
- Keywords
- Bowel Preparation with Polyethylene Glycol (PEG) Laxatives, Gut microbiota
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel Preparation with Polyethylene Glycol (PEG) LaxativesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bowel Preparation with Polyethylene Glycol (PEG) Laxatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 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.
Measured: Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start23 Feb 2024
- Primary completion23 Feb 2027 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huaping Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huaping Xie, Tongji Hospital
- Investigators
- ping h Xie, Doctor, Study chair, Tongji Medical College of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478029
- Sponsor's protocol ID
- TJ-IRB202402126
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this trial, including fecal metagenomic sequencing data and questionnaire responses, will not be shared to protect participant privacy. Summary results will be disseminated through publication in peer-reviewed journals. As stated in the informed consent form, de-identified aggregate data may be made available for public query, but individual-level data will not be shared.
Publications
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.
PubMed 21454446Brown 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.
PubMed 29227180Vitetta L, Vitetta G, Hall S. The Brain-Intestinal Mucosa-Appendix- Microbiome-Brain Loop. Diseases. 2018 Apr 1;6(2):23. doi: 10.3390/diseases6020023.
PubMed 29614774Nakahara 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.
PubMed 36750613Guinane 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.
PubMed 23322636Cai 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.
PubMed 34603252Girard-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.
PubMed 29503124Song 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.
PubMed 33350352Tropini 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.
PubMed 29906449
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Polyethylene Glycol (PEG) Bowel Preparation on Intestinal Microbiota Composition and Diversity in Patients Undergoing Appendectomy
- ClinicalTrials.gov ID
- NCT07478029
- Acronym / sponsor ID
- TJ-IRB202402126
- Conditions
- Appendicitis, Appendicitis Acute
- Keywords
- Bowel Preparation with Polyethylene Glycol (PEG) Laxatives, Gut microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Huaping XieUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 18 Mar 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The human gut microbiota constitutes one of the densest microbial communities on Earth, encompassing a highly diverse assembly of microorganisms that perform metabolic, immune, and protective functions crucial to human health. The gastrointestinal microbiota is influenced by a variety of factors, including genetics, host physiological status (such as age, disease, and stress), and environmental conditions such as living environment and medication use. Among these numerous perturbing factors, iatrogenic interventions-particularly the bowel cleansing procedure essential before colonoscopy-exert a particularly significant impact on the gut microecosystem.
Current colonoscopy preparation involves the administration of large volumes of polyethylene glycol (PEG2000-4000) as a laxative and lubricant. Existing studies indicate that PEG use may markedly reduce microbial richness and diversity. Specifically, PEG ingestion can lead to aberrant proliferation of *Akkermansia* species, a reduction in Firmicutes, and an increased load and virulence gene expression of pathogens such as *Citrobacter*. Metabolically, PEG use may result in decreased dehydroxylation of primary bile acids and altered cholesterol metabolism, ultimately contributing to diarrhea, weight loss, disruption of lipid and energy metabolism, and intestinal inflammation. Thus, extensive use of PEG may cause long-term and irreversible damage to the gut microbiota, posing substantial risks to health.
The appendix, located at the base of the cecum, is an elongated, tubular structure protruding from the posterior wall of the cecum. As an integral component of the intestinal mucosal immune system, its lumen harbors rich biofilm structures that provide an "ecological sanctuary" for commensal bacteria, shielding them from the flushing effect of intestinal contents. Emerging research indicates that under physiological conditions, the appendix continuously receives and shelters specific microbiota from the proximal colon, particularly adherent members of the Firmicutes and Bacteroidetes phyla. When microbial dysbiosis occurs in the host-due to factors such as infection, antibiotic exposure, or bowel cleansing-the appendix can serve as a microbial reservoir, accelerating the process of microecological restoration. Therefore, the appendix is considered a "natural backup system" for the gut microbiota, and its integrity plays an irreplaceable role in resisting microbial disturbances and maintaining microecological resilience. Historically, appendicitis has ranked as the most common acute abdominal emergency, and once acute appendicitis occurs, traditional therapy often involves appendectomy. Extensive epidemiological evidence has shown that post-appendectomy populations have significantly elevated risks of *Clostridioides difficile* infection, colorectal cancer, Parkinson's disease, and depression. Metagenomic studies further reveal that appendectomized individuals exhibit reduced gut microbial diversity, persistently low abundance of short-chain fatty acid-producing genera (e.g., *Faecalibacterium* and *Roseburia*), diminished stability of microbial networks, and compromised resistance and resilience against external disturbances. These findings suggest that appendiceal loss may place the gut microecosystem in a state of "fragile equilibrium," wherein superimposing the strong perturbation of PEG-based bowel cleansing could induce more severe and persistent dysbiosis.
This study adopts a parallel-controlled, monitored clinical trial design, enrolling a total of approximately 10 participants. Eligible subjects must have previously undergone appendectomy or right hemicolectomy with appendectomy, be aged 18-75 years, be scheduled for colonoscopy, be generally healthy, and have no history of major organ diseases. Control subjects must be aged 18-75 years, have no history of appendectomy or right hemicolectomy with appendectomy, be generally healthy, and have no history of major organ diseases. Both groups must meet corresponding exclusion criteria, including: contraindications to colonoscopy (e.g., organic diseases such as cardiopulmonary insufficiency), inability to tolerate PEG laxatives, pregnancy, long-standing history of intestinal diseases, or antibiotic use within the past six months.
Fecal samples will be collected at multiple time points: before colonoscopy, at the first non-watery stool after colonoscopy, and at one month, three months, and six months post-colonoscopy. Metagenomic sequencing will be used to detect fecal gut microbial information, and bioinformatics analysis will be performed with a focus on: (1) the long-term effects of colonoscopy on the gut microbiota and the disturbance characteristics during gut microecological recovery following appendectomy; (2) designing microecological restoration probiotic formulations based on microbiome features; and (3) screening representative fecal samples for subsequent animal experiments.
This study will not use recruitment advertisements; participation is entirely voluntary. Subjects will be informed of potential risks during the experiment and will sign informed consent forms upon agreeing to join the study. Volunteers who consent to participate will complete a questionnaire to assess their intestinal health status and other health conditions and will be screened according to the aforementioned selection and exclusion criteria. Collected samples will be labeled with codes to ensure that no personally identifiable information is disclosed. Throughout the study, participants' identities will be kept confidential, with only codes and disease phenotypes visible. Subjects may withdraw from the study at any time.
This study will analyze the composition and structure of participants' gut microbiota, and subjects will be kept informed of the progress of the tests and analyses in a timely manner and will have access to their own relevant data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appendectomy Group | – | Drug: Bowel Preparation with Polyethylene Glycol (PEG) LaxativesPatients 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. |
| Non-Appendectomy Group | – | Drug: Bowel Preparation with Polyethylene Glycol (PEG) LaxativesAge-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Aged 18-75 years.
- Scheduled to undergo colonoscopy.
- Generally healthy without major organ diseases.
Key exclusion criteria (6 listed)
- Allergy or intolerance to PEG laxatives.
- Pregnant or lactating women.
- Mental disorders.
- Use of antibiotics within 6 months prior to study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowel Preparation with Polyethylene Glycol (PEG) LaxativesAll 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. | Drug | Appendectomy Group, Non-Appendectomy Group |
Primary outcome
Change in Relative Abundance of Specific Gut Microbes
Time frame: Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy
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 .
2.Difference in Gut Microbiota Recovery Trajectory Between Appendectomy and Non-Appendectomy Groups
Time frame: Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy
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.
3.Change in Metabolic Function of Gut Microbiota
Time frame: Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 21454446Ghosh 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.
- Background: PubMed 29227180Brown 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.
- Background: PubMed 29614774Vitetta L, Vitetta G, Hall S. The Brain-Intestinal Mucosa-Appendix- Microbiome-Brain Loop. Diseases. 2018 Apr 1;6(2):23. doi: 10.3390/diseases6020023.
- Background: PubMed 36750613Nakahara 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.
- Background: PubMed 23322636Guinane 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.
- Background: PubMed 34603252Cai 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.
- Background: PubMed 29503124Girard-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.
- Background: PubMed 33350352Song 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.
- Background: PubMed 29906449Tropini 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.
- Individual participant dataSharing planned: No. Individual participant data collected during this trial, including fecal metagenomic sequencing data and questionnaire responses, will not be shared to protect participant privacy. Summary results will be disseminated through publication in peer-reviewed journals. As stated in the informed consent form, de-identified aggregate data may be made available for public query, but individual-level data will not be shared.
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ping h Xie, Doctor study chair
Tongji Medical College of Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Appendicitis Acute, run by Huaping Xie 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ping h Xie (86+13437187007, hpxie@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Relative Abundance of Specific Gut Microbes (time frame: Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy). 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 NCT07478029, which also lists 9 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 17 Mar 2026.