CholecystectomyNCT07439640
PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy
An observational study of Cholecystectomy, run by Tongji Hospital at 1 site in China.
Trial summary
This observational study aims to investigate the impact of polyethylene glycol (PEG) laxatives used for bowel preparation on the gut microbiota of patients who have undergone cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystectomy
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2025to 16 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult patients scheduled for colonoscopy at the Department of Gastroenterology, Tongji Hospital, Wuhan, China. Participants are recruited consecutively from the outpatient clinic and voluntarily enrolled after providing written informed consent. Two cohorts are defined based on history of cholecystectomy: individuals with prior cholecystectomy (gallbladder removal group) and individuals with an intact gallbladder (normal group). All participants undergo routine bowel preparation with PEG-based laxatives and provide stool samples longitudinally over a 6-month period. No experimental interventions are administered.
Who may be able to join
- Scheduled to undergo colonoscopy with polyethylene glycol (PEG)-based bowel preparation.
- For the gallbladder removal group: prior cholecystectomy performed at least 6 months before enrolment.
- For the normal group: intact gallbladder (no history of cholecystectomy).
- Willing and able to provide written informed consent.
- Willing to collect and mail stool samples at five specified time points (baseline, first non-watery stool after colonoscopy, 1 month, 3 months, 6 months).
Who cannot join
- Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency, acute gastrointestinal bleeding, severe coagulopathy).
- Known intolerance or allergy to polyethylene glycol (PEG).
- Use of antibiotics, probiotics, or prebiotics within 6 months prior to enrolment.
- Pregnancy or breastfeeding.
- Mental disorders or any condition that may compromise the ability to comply with study procedures.
- Major organ diseases (e.g., liver cirrhosis, chronic kidney disease stage 4-5, uncontrolled diabetes mellitus).
- Participation in another interventional clinical trial within the last 3 months.
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
qiang Ding
About this study
Official title: Clinical Experimental Study on the Impact of PEG Laxatives for Intestinal Preparation on Gut Microbiota in Patients Undergoing Cholecystectomy
This observational study aims to investigate the impact of polyethylene glycol (PEG) laxatives used for bowel preparation on the gut microbiota of patients who have undergone cholecystectomy. Emerging evidence suggests that both cholecystectomy and high-dose PEG exposure can independently alter the intestinal microbial ecosystem. However, whether the microbiota of post-cholecystectomy patients is more vulnerable to PEG-induced perturbation and exhibits delayed recovery remains unknown.
Approximately 10 adults with prior cholecystectomy scheduled for colonoscopy and 10 age-matched controls without cholecystectomy will be enrolled. All participants will undergo standard colonoscopy preparation with PEG-based laxatives. Stool samples will be collected at five time points: before bowel preparation, at the first non-watery stool after colonoscopy, and at 1, 3, and 6 months post-colonoscopy. Metagenomic shotgun sequencing will be performed to characterise the taxonomic and functional profiles of the gut microbiome. Alpha diversity, beta diversity, differential abundance, and metabolic pathway alterations will be compared within and between groups over time.
The findings are expected to reveal whether cholecystectomised individuals are more susceptible to long-term gut dysbiosis after PEG exposure, and to inform future strategies for microbiota restoration in this specific population.
Read the detailed description
Gut microbiota dysbiosis has been implicated in various gastrointestinal and metabolic disorders. Polyethylene glycol (PEG)-based laxatives, routinely administered for bowel cleansing before colonoscopy, induce transient osmotic diarrhoea and have been shown in animal models to cause prolonged alterations in microbial composition and function. Meanwhile, cholecystectomy, one of the most frequently performed abdominal surgeries, alters bile acid flow and enterohepatic circulation, which can modulate the gut microbial ecosystem and has been associated with increased risk of post-operative diarrhoea and even colorectal neoplasia. Despite these independent effects, the combined influence of cholecystectomy and PEG-based bowel preparation on the human gut microbiome has not been systematically investigated.
This is a prospective, parallel-group, observational cohort study conducted at Tongji Hospital, Huazhong University of Science and Technology. A total of approximately 20 participants will be recruited and allocated into two groups: the cholecystectomy group, consisting of individuals who have undergone cholecystectomy at least six months prior to enrolment and are scheduled for a screening or surveillance colonoscopy; and the control group, comprising individuals with an intact gallbladder who are matched for age and sex and are also scheduled for colonoscopy.
Eligible participants are aged 18 to 75 years, have no history of major organ disease, have not used antibiotics, probiotics, or prebiotics within six months before enrolment, and have no contraindications to colonoscopy or PEG intake. Exclusion criteria include pregnancy, severe cardiopulmonary insufficiency, mental disorders, and inability to comply with stool collection procedures.
All participants will undergo standard bowel preparation using 2-4 L of PEG-4000/3350 solution according to routine clinical practice. No experimental intervention is administered.
Stool specimens of approximately 10 g each will be self-collected by participants at home using provided collection kits at five predefined time points: within three days before bowel preparation (baseline), at the first non-watery stool after colonoscopy, and at one month, three months, and six months after colonoscopy, each with a permitted window of ±7 days for the one-month visit and ±14 days for the three- and six-month visits. Samples will be immediately frozen at -80 °C until DNA extraction. Faecal genomic DNA will be subjected to shotgun metagenomic sequencing on the DNBSEQ-T7 platform. Raw reads will be filtered using fastp to remove adapter contamination and low-quality sequences. High-quality reads will be aligned to the human genome to exclude host DNA, and the remaining reads will be used for taxonomic profiling with MetaPhlAn or Kraken2/Bracken, and functional profiling with HUMAnN3 against the UniRef90 and KEGG databases.
The primary outcome is the change in gut microbial α-diversity, as measured by Shannon, Simpson, and Chao1 indices, and β-diversity, assessed by Bray-Curtis dissimilarity and UniFrac distances, both within and between groups across the five time points.
Secondary outcomes include the temporal dynamics of specific taxa, such as the phylum Firmicutes/Bacteroidetes ratio and butyrate-producing genera; differential abundance of species and functional pathways, including KEGG modules and MetaCyc reactions; and the correlation between microbial compositional shifts and clinical parameters, for example time since cholecystectomy and bowel movement frequency.
All statistical analyses will be performed using R. Within-group comparisons over time will be assessed by the Friedman test or repeated-measures ANOVA, or non-parametric equivalents, followed by post-hoc pairwise Wilcoxon signed-rank tests with false discovery rate correction. Between-group comparisons at each time point will be analysed using the Mann-Whitney U test or linear mixed-effects models adjusting for potential confounders. Principal coordinate analysis based on Bray-Curtis distances will visualise community separation, and permutational multivariate analysis of variance will test for significant clustering. Linear discriminant analysis effect size will identify taxa with differential abundance between groups, using an LDA score threshold of >2.0 and p <0.05.
The study protocol has been approved by the Medical Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Written informed consent will be obtained from all participants prior to enrolment. Results will be disseminated through peer-reviewed publications and scientific conferences.
By longitudinally profiling the gut microbiota of cholecystectomised and non-cholecystectomised individuals exposed to the same bowel preparation regimen, this study will delineate whether prior gallbladder removal predisposes patients to a more severe or prolonged PEG-induced dysbiosis. The findings may provide a microbiological rationale for tailored bowel preparation protocols or microbiota-targeted interventions, such as probiotics or post-colonoscopy dietary guidance, in this growing patient population.
- Conditions
- Cholecystectomy
- Keywords
- Gut Microbiota, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal group | Individuals with an intact gallbladder, matched for age and sex, who are scheduled for colonoscopy and serve as the control cohort. The same eligibility criteria, exclusion criteria, and observation procedures as the gallbladder removal group apply: participants are aged 18-75 years, free from major organ diseases, and have no recent use of antibiotics, probiotics, or prebiotics. Pregnancy, severe cardiopulmonary insufficiency, mental disorders, and colonoscopy/PEG contraindications are exclusionary. Participants undergo identical PEG-based bowel preparation and provide stool samples at the same five time points. No intervention is administered. Approximately 10 participants are planned for this cohort. | |
| Gallbladder removal group | Individuals who have undergone cholecystectomy at least six months prior to enrolment and are scheduled for a screening or surveillance colonoscopy. Eligible participants are aged 18-75 years, have no history of major organ disease, and have not used antibiotics, probiotics, or prebiotics within six months before enrolment. Exclusion criteria include pregnancy, severe cardiopulmonary insufficiency, mental disorders, and contraindications to colonoscopy or PEG intake. Participants receive standard bowel preparation with PEG-based laxatives according to routine clinical practice. No experimental intervention is administered. Stool samples are self-collected at five time points: within three days before bowel preparation, at the first non-watery stool after colonoscopy, and at one, three, and six months after colonoscopy. A total of approximately 10 participants are planned for this cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbial diversity
Assessment of α-diversity (Shannon index, Simpson index, Chao1 richness estimator) and β-diversity (Bray-Curtis dissimilarity, weighted and unweighted UniFrac distances) based on shotgun metagenomic sequencing of faecal samples. Comparisons will be made within each group across time points and between the gallbladder removal group and the normal group at each time point.
Measured: Baseline (within 3 days before bowel preparation);first non-watery stool after colonoscopy 9up to 48 hours after colonoscopy; 1 month (±7 days) after colonoscopy; 3 months (±14 days) after colonoscopy; 6 months (±14 days) after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start16 Jan 2025
- Primary completion16 Mar 2027 (estimated)
- Study completion16 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huaping Xie, Tongji Hospital
- Investigators
- ping h Xie, Study chair, Tongji Medical College of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439640
- Sponsor's protocol ID
- TJ-IRB202501007
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected during this study, including: * Demographic information (age, sex) * Clinical characteristics (time since cholecystectomy, bowel movement frequency) * Metagenomic sequencing data (raw FASTQ files, taxonomic abundance tables, functional pathway profiles) * Stool sample collection time points * Laboratory processing and quality control data
Publications
van der Wulp MY, Derrien M, Stellaard F, Wolters H, Kleerebezem M, Dekker J, Rings EH, Groen AK, Verkade HJ. Laxative treatment with polyethylene glycol decreases microbial primary bile salt dehydroxylation and lipid metabolism in the intestine of rats. Am J Physiol Gastrointest Liver Physiol. 2013 Oct 1;305(7):G474-82. doi: 10.1152/ajpgi.00375.2012. Epub 2013 Jul 18.
PubMed 23868407Zou Y, Zeng S, Chen M, Li S, Fu Q, Zhou S, Zhou J. Gut microbiota in children with split-dose bowel preparations revealed by metagenomics. Front Cell Infect Microbiol. 2023 Jul 18;13:1202007. doi: 10.3389/fcimb.2023.1202007. eCollection 2023.
PubMed 37533931Batista L, Robles V, Manichanh C, Ruiz L, Guagnozzi D, Pinsach F, Guarner F, Fernandez-Banares F. Colonic bacterial diversity and dysbiosis in active microscopic colitis as compared to chronic diarrhoea and healthy controls: effect of polyethylene glycol after bowel lavage for colonoscopy. BMC Gastroenterol. 2022 Jun 28;22(1):320. doi: 10.1186/s12876-022-02392-w.
PubMed 35764931Amaral Raposo M, Sousa Oliveira E, Dos Santos A, Guadagnini D, El Mourabit H, Housset C, Lemoinne S, Abdalla Saad MJ. Impact of cholecystectomy on the gut-liver axis and metabolic disorders. Clin Res Hepatol Gastroenterol. 2024 Aug;48(7):102370. doi: 10.1016/j.clinre.2024.102370. Epub 2024 May 9.
PubMed 38729564Tang B, Li S, Li X, He J, Zhou A, Wu L, Xiao X, Wang S, Jiang H, Jian J, Hou Z, Ge Y, Lei Y, Zhou J, Tu D, Lu C, Yang M, Yang S. Cholecystectomy-related gut microbiota dysbiosis exacerbates colorectal tumorigenesis. Nat Commun. 2025 Aug 16;16(1):7638. doi: 10.1038/s41467-025-62956-8.
PubMed 40819131Tan L, Jia F, Liu Y. Advances in research on the role of gut microbiota in the pathogenesis and precision management of gallstone disease. Front Med (Lausanne). 2025 Jun 25;12:1535355. doi: 10.3389/fmed.2025.1535355. eCollection 2025.
PubMed 40636353McGuinness AJ, O'Hely M, Stupart D, Watters D, Dawson SL, Hair C, Berk M, Mohebbi M, Loughman A, Guest G, Jacka FN. Prior Appendicectomy and Gut Microbiota Re-Establishment in Adults after Bowel Preparation and Colonoscopy. Biomedicines. 2024 Aug 23;12(9):1938. doi: 10.3390/biomedicines12091938.
PubMed 39335452Chen J, Sali A, Vitetta L. The gallbladder and vermiform appendix influence the assemblage of intestinal microorganisms. Future Microbiol. 2020 May;15:541-555. doi: 10.2217/fmb-2019-0325. Epub 2020 Jun 1.
PubMed 32478580
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Experimental Study on the Impact of PEG Laxatives for Intestinal Preparation on Gut Microbiota in Patients Undergoing Cholecystectomy
- ClinicalTrials.gov ID
- NCT07439640
- Acronym / sponsor ID
- TJ-IRB202501007
- Conditions
- Cholecystectomy
- Keywords
- Gut Microbiota, Colonoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 27 Feb 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.
This observational study aims to investigate the impact of polyethylene glycol (PEG) laxatives used for bowel preparation on the gut microbiota of patients who have undergone cholecystectomy. Emerging evidence suggests that both cholecystectomy and high-dose PEG exposure can independently alter the intestinal microbial ecosystem. However, whether the microbiota of post-cholecystectomy patients is more vulnerable to PEG-induced perturbation and exhibits delayed recovery remains unknown.
Approximately 10 adults with prior cholecystectomy scheduled for colonoscopy and 10 age-matched controls without cholecystectomy will be enrolled. All participants will undergo standard colonoscopy preparation with PEG-based laxatives. Stool samples will be collected at five time points: before bowel preparation, at the first non-watery stool after colonoscopy, and at 1, 3, and 6 months post-colonoscopy. Metagenomic shotgun sequencing will be performed to characterise the taxonomic and functional profiles of the gut microbiome. Alpha diversity, beta diversity, differential abundance, and metabolic pathway alterations will be compared within and between groups over time.
The findings are expected to reveal whether cholecystectomised individuals are more susceptible to long-term gut dysbiosis after PEG exposure, and to inform future strategies for microbiota restoration in this specific population.
Detailed description
Gut microbiota dysbiosis has been implicated in various gastrointestinal and metabolic disorders. Polyethylene glycol (PEG)-based laxatives, routinely administered for bowel cleansing before colonoscopy, induce transient osmotic diarrhoea and have been shown in animal models to cause prolonged alterations in microbial composition and function. Meanwhile, cholecystectomy, one of the most frequently performed abdominal surgeries, alters bile acid flow and enterohepatic circulation, which can modulate the gut microbial ecosystem and has been associated with increased risk of post-operative diarrhoea and even colorectal neoplasia. Despite these independent effects, the combined influence of cholecystectomy and PEG-based bowel preparation on the human gut microbiome has not been systematically investigated.
This is a prospective, parallel-group, observational cohort study conducted at Tongji Hospital, Huazhong University of Science and Technology. A total of approximately 20 participants will be recruited and allocated into two groups: the cholecystectomy group, consisting of individuals who have undergone cholecystectomy at least six months prior to enrolment and are scheduled for a screening or surveillance colonoscopy; and the control group, comprising individuals with an intact gallbladder who are matched for age and sex and are also scheduled for colonoscopy.
Eligible participants are aged 18 to 75 years, have no history of major organ disease, have not used antibiotics, probiotics, or prebiotics within six months before enrolment, and have no contraindications to colonoscopy or PEG intake. Exclusion criteria include pregnancy, severe cardiopulmonary insufficiency, mental disorders, and inability to comply with stool collection procedures.
All participants will undergo standard bowel preparation using 2-4 L of PEG-4000/3350 solution according to routine clinical practice. No experimental intervention is administered.
Stool specimens of approximately 10 g each will be self-collected by participants at home using provided collection kits at five predefined time points: within three days before bowel preparation (baseline), at the first non-watery stool after colonoscopy, and at one month, three months, and six months after colonoscopy, each with a permitted window of ±7 days for the one-month visit and ±14 days for the three- and six-month visits. Samples will be immediately frozen at -80 °C until DNA extraction. Faecal genomic DNA will be subjected to shotgun metagenomic sequencing on the DNBSEQ-T7 platform. Raw reads will be filtered using fastp to remove adapter contamination and low-quality sequences. High-quality reads will be aligned to the human genome to exclude host DNA, and the remaining reads will be used for taxonomic profiling with MetaPhlAn or Kraken2/Bracken, and functional profiling with HUMAnN3 against the UniRef90 and KEGG databases.
The primary outcome is the change in gut microbial α-diversity, as measured by Shannon, Simpson, and Chao1 indices, and β-diversity, assessed by Bray-Curtis dissimilarity and UniFrac distances, both within and between groups across the five time points.
Secondary outcomes include the temporal dynamics of specific taxa, such as the phylum Firmicutes/Bacteroidetes ratio and butyrate-producing genera; differential abundance of species and functional pathways, including KEGG modules and MetaCyc reactions; and the correlation between microbial compositional shifts and clinical parameters, for example time since cholecystectomy and bowel movement frequency.
All statistical analyses will be performed using R. Within-group comparisons over time will be assessed by the Friedman test or repeated-measures ANOVA, or non-parametric equivalents, followed by post-hoc pairwise Wilcoxon signed-rank tests with false discovery rate correction. Between-group comparisons at each time point will be analysed using the Mann-Whitney U test or linear mixed-effects models adjusting for potential confounders. Principal coordinate analysis based on Bray-Curtis distances will visualise community separation, and permutational multivariate analysis of variance will test for significant clustering. Linear discriminant analysis effect size will identify taxa with differential abundance between groups, using an LDA score threshold of >2.0 and p <0.05.
The study protocol has been approved by the Medical Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Written informed consent will be obtained from all participants prior to enrolment. Results will be disseminated through peer-reviewed publications and scientific conferences.
By longitudinally profiling the gut microbiota of cholecystectomised and non-cholecystectomised individuals exposed to the same bowel preparation regimen, this study will delineate whether prior gallbladder removal predisposes patients to a more severe or prolonged PEG-induced dysbiosis. The findings may provide a microbiological rationale for tailored bowel preparation protocols or microbiota-targeted interventions, such as probiotics or post-colonoscopy dietary guidance, in this growing patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | –Individuals with an intact gallbladder, matched for age and sex, who are scheduled for colonoscopy and serve as the control cohort. The same eligibility criteria, exclusion criteria, and observation procedures as the gallbladder removal group apply: participants are aged 18-75 years, free from major organ diseases, and have no recent use of antibiotics, probiotics, or prebiotics. Pregnancy, severe cardiopulmonary insufficiency, mental disorders, and colonoscopy/PEG contraindications are exclusionary. Participants undergo identical PEG-based bowel preparation and provide stool samples at the same five time points. No intervention is administered. Approximately 10 participants are planned for this cohort. |
| Gallbladder removal group | – | –Individuals who have undergone cholecystectomy at least six months prior to enrolment and are scheduled for a screening or surveillance colonoscopy. Eligible participants are aged 18-75 years, have no history of major organ disease, and have not used antibiotics, probiotics, or prebiotics within six months before enrolment. Exclusion criteria include pregnancy, severe cardiopulmonary insufficiency, mental disorders, and contraindications to colonoscopy or PEG intake. Participants receive standard bowel preparation with PEG-based laxatives according to routine clinical practice. No experimental intervention is administered. Stool samples are self-collected at five time points: within three days before bowel preparation, at the first non-watery stool after colonoscopy, and at one, three, and six months after colonoscopy. A total of approximately 10 participants are planned for this cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients scheduled for colonoscopy at the Department of Gastroenterology, Tongji Hospital, Wuhan, China. Participants are recruited consecutively from the outpatient clinic and voluntarily enrolled after providing written informed consent. Two cohorts are defined based on history of cholecystectomy: individuals with prior cholecystectomy (gallbladder removal group) and individuals with an intact gallbladder (normal group). All participants undergo routine bowel preparation with PEG-based laxatives and provide stool samples longitudinally over a 6-month period. No experimental interventions are administered.
Key inclusion criteria (5 listed)
- Scheduled to undergo colonoscopy with polyethylene glycol (PEG)-based bowel preparation.
- For the gallbladder removal group: prior cholecystectomy performed at least 6 months before enrolment.
- For the normal group: intact gallbladder (no history of cholecystectomy).
- Willing and able to provide written informed consent.
- Willing to collect and mail stool samples at five specified time points (baseline, first non-watery stool after colonoscopy, 1 month, 3 months, 6 months).
Key exclusion criteria (7 listed)
- Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency, acute gastrointestinal bleeding, severe coagulopathy).
- Known intolerance or allergy to polyethylene glycol (PEG).
- Use of antibiotics, probiotics, or prebiotics within 6 months prior to enrolment.
- Pregnancy or breastfeeding.
- Mental disorders or any condition that may compromise the ability to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in gut microbial diversity
Time frame: Baseline (within 3 days before bowel preparation);first non-watery stool after colonoscopy 9up to 48 hours after colonoscopy; 1 month (±7 days) after colonoscopy; 3 months (±14 days) after colonoscopy; 6 months (±14 days) after colonoscopy
Assessment of α-diversity (Shannon index, Simpson index, Chao1 richness estimator) and β-diversity (Bray-Curtis dissimilarity, weighted and unweighted UniFrac distances) based on shotgun metagenomic sequencing of faecal samples. Comparisons will be made within each group across time points and between the gallbladder removal group and the normal group at each time point.
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 27 Feb 2026.
- Background: PubMed 23868407van der Wulp MY, Derrien M, Stellaard F, Wolters H, Kleerebezem M, Dekker J, Rings EH, Groen AK, Verkade HJ. Laxative treatment with polyethylene glycol decreases microbial primary bile salt dehydroxylation and lipid metabolism in the intestine of rats. Am J Physiol Gastrointest Liver Physiol. 2013 Oct 1;305(7):G474-82. doi: 10.1152/ajpgi.00375.2012. Epub 2013 Jul 18.
- Background: PubMed 37533931Zou Y, Zeng S, Chen M, Li S, Fu Q, Zhou S, Zhou J. Gut microbiota in children with split-dose bowel preparations revealed by metagenomics. Front Cell Infect Microbiol. 2023 Jul 18;13:1202007. doi: 10.3389/fcimb.2023.1202007. eCollection 2023.
- Background: PubMed 35764931Batista L, Robles V, Manichanh C, Ruiz L, Guagnozzi D, Pinsach F, Guarner F, Fernandez-Banares F. Colonic bacterial diversity and dysbiosis in active microscopic colitis as compared to chronic diarrhoea and healthy controls: effect of polyethylene glycol after bowel lavage for colonoscopy. BMC Gastroenterol. 2022 Jun 28;22(1):320. doi: 10.1186/s12876-022-02392-w.
- Background: PubMed 38729564Amaral Raposo M, Sousa Oliveira E, Dos Santos A, Guadagnini D, El Mourabit H, Housset C, Lemoinne S, Abdalla Saad MJ. Impact of cholecystectomy on the gut-liver axis and metabolic disorders. Clin Res Hepatol Gastroenterol. 2024 Aug;48(7):102370. doi: 10.1016/j.clinre.2024.102370. Epub 2024 May 9.
- Background: PubMed 40819131Tang B, Li S, Li X, He J, Zhou A, Wu L, Xiao X, Wang S, Jiang H, Jian J, Hou Z, Ge Y, Lei Y, Zhou J, Tu D, Lu C, Yang M, Yang S. Cholecystectomy-related gut microbiota dysbiosis exacerbates colorectal tumorigenesis. Nat Commun. 2025 Aug 16;16(1):7638. doi: 10.1038/s41467-025-62956-8.
- Background: PubMed 40636353Tan L, Jia F, Liu Y. Advances in research on the role of gut microbiota in the pathogenesis and precision management of gallstone disease. Front Med (Lausanne). 2025 Jun 25;12:1535355. doi: 10.3389/fmed.2025.1535355. eCollection 2025.
- Background: PubMed 39335452McGuinness AJ, O'Hely M, Stupart D, Watters D, Dawson SL, Hair C, Berk M, Mohebbi M, Loughman A, Guest G, Jacka FN. Prior Appendicectomy and Gut Microbiota Re-Establishment in Adults after Bowel Preparation and Colonoscopy. Biomedicines. 2024 Aug 23;12(9):1938. doi: 10.3390/biomedicines12091938.
- Background: PubMed 32478580Chen J, Sali A, Vitetta L. The gallbladder and vermiform appendix influence the assemblage of intestinal microorganisms. Future Microbiol. 2020 May;15:541-555. doi: 10.2217/fmb-2019-0325. Epub 2020 Jun 1.
- Individual participant dataSharing planned: No. De-identified individual participant data collected during this study, including: * Demographic information (age, sex) * Clinical characteristics (time since cholecystectomy, bowel movement frequency) * Metagenomic sequencing data (raw FASTQ files, taxonomic abundance tables, functional pathway profiles) * Stool sample collection time points * Laboratory processing and quality control data
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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 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 Cholecystectomy, run by Tongji Hospital 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 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: looking for participants now, as of the sponsor's last update on 27 Feb 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?
Changes in gut microbial diversity (time frame: Baseline (within 3 days before bowel preparation);first non-watery stool after colonoscopy 9up to 48 hours after colonoscopy; 1 month (±7 days) after colonoscopy; 3 months (±14 days) after colonoscopy; 6 months (±14 days) after colonoscopy). 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 NCT07439640, which also lists 8 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 27 Feb 2026.