Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy

NCT06339697 | Completed Phase 4

• 1 other identifier: 2022-KY-233
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the role of different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) on the composition, evolution and recovery of the gut microbiome of patients with colonic polyps undergoing bowel preparation.

Conditions

Colon Polyp; Cathartic Colon

Keywords

bowel preparation; gut microbiome; Cathartics

Outcome Measures

Primary Outcomes (5)

• gut microbiome-taxonomy

  16s sequencing results of feces. Based on the abundance information (absolute and relative) from ZOTU and its taxonomic annotations, the total number of sequences at each taxonomic level (Kingdom, Phylum, Class, Order, Family, Genus) for each sample and its proportion of the total number of sequences were summarized.

  Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation

• gut microbiome-heatmap

  Based on the species annotations and abundance information of all samples at the genus level, the genera of concern (30 genera with high default abundance rankings) and their abundance information in each sample are selected to draw heat maps. At the same time, and clustering at both the level of taxonomic information and differences between samples, one can look for patterns of aggregation of species or samples.

  Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation

• gut microbiome-Alpha Diversity

  Includes both the diversity of species in the sample (Richness) and the overall evenness of the distribution of how many species make up the sample (Evenness). Indices such as Richness, Chao1, Shannon, Simpson, Dominance and Equitability are commonly used to assess the species diversity of a sample.

  Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation

• gut microbiome-Beta Diversity

  Beta Diversity is a comparison of microbial community composition between samples. Bray Curtis, Weighted UniFrac and Unweighted UniFrac distances were calculated based on the ZOTUs abundance information of the samples to assess the differences in microbial community composition between samples. Based on the above distance matrix, it was analyzed by multivariate statistical methods such as Principal Component Analysis, Principal Co-ordinates AnalysisUnweighted Pair-group Method with Arithmetic Means to further from the results to explore the differences in microbial community structure in each sample and the differences in the contribution of different classifications to the samples.

  Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation

• gut microbiome-Functional predictions

  In the 16S analysis, a preliminary functional spectrum prediction analysis was performed. The constructed ZOTU sequences were aligned with bacterial 16S sequence databases of known function (e.g., KEGG 16S Sequence Database, Silva SSU Database,) to obtain information on bacterial abundance in environmental samples. This abundance information is mapped directly or indirectly to the annotated microbial genomes of the KEGG databases, combined with the number of 16S rRNA genes and the abundance information of the functional genes (characterized using the KEGG Ortholog, KO), to obtain functional data on (some of the) known bacteria contained in the samples, as well as their abundance information.

  Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation

Secondary Outcomes (10)

• Age

  Before bowel preparation

• Gender

  Before bowel preparation

• Height

  Before bowel preparation

• Weight

  Before bowel preparation

• BMI

  Before bowel preparation

Study Arms (2)

compounded polyethylene glycol electrolyte dispersions

ACTIVE COMPARATOR

For patients undergoing colonoscopic polypectomy in the morning, 2-3 L should be taken the night before and 1-2 L the morning of the procedure, and for patients undergoing colonoscopy in the afternoon, divided doses should be taken on the same day.

Drug: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)

compounded sodium pico-sulfate

ACTIVE COMPARATOR

Oral sodium picolinate/magnesium citrate (PicolaxÒ), 2 sachets, each sachet contains 0.01 g of sodium picolinate, 3.5 g of magnesium oxide, 12.0 g of citric acid, each sachet should be dissolved in 150 ml of water, sachet 1 should be taken at 7:00 p.m.-9:00 p.m. on the first day of the operation, and cite 1,500-2,000 ml of clarified fluids after the dose and before going to bed, sachet 2 should be taken 4-6 hours prior to colonoscopy, and 750 ml of clarified fluids should be taken orally before the colonoscopy. The second bag should be taken 4-6 hours before the colonoscopy and 750 ml of clarified liquid should be taken orally before the colonoscopy.

Drug: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate)

Interventions

different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) DRUG

Bowel preparation with different types of laxatives (compounded polyethylene glycol electrolytes and compounded sodium picosulfate)

compounded polyethylene glycol electrolyte dispersions; compounded sodium pico-sulfate

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All colon polyps diagnosed by electronic colonoscopy
• Age above 18 years old
• Patients sign an informed consent form, agree to cooperate with the study of this project, and collect fecal specimens on time to receive follow-up visits

You may not qualify if:

• Patients who received antibiotics, PPIs 2 weeks before the study
• Patients who consumed probiotics or herbs 2 weeks prior to the study
• Had a colonoscopy or used diarrhea-inducing drugs or gastrointestinal stimulants 1 week prior to the study
• Gastrointestinal surgery and gastrointestinal endoscopic procedures in the 1 month prior to the study
• Bacterial or parasitic intestinal infections in the 1 month prior to the study
• Patients on long-term low-calorie diets, vegan diets, gluten-free diets and other "special" diets
• Pregnant/nursing patients
• Patients with a history of hypersensitivity to relevant medications
• Patients with contraindications to sodium picosulfate: renal insufficiency, renal transplant recipients, congestive heart failure, symptomatic ischemic heart disease within the last 6 months, cirrhosis of the liver, patients on hemodialysis or peritoneal dialysis, patients taking certain medications - renin-angiotensin blockers, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), and patients taking medications known to trigger the syndrome of inappropriate secretion of antidiuretic hormone. patients taking medications known to induce the syndrome of inappropriate antidiuretic hormone secretion (tricyclic antidepressants, selective 5-hydroxytryptamine reuptake inhibitors, multiple antipsychotics, and carbamazepine)
• Patients with contraindications to colonoscopy, such as severe hypertension, anemia, coronary artery disease, cardiopulmonary insufficiency, etc.
• Patients with contraindications to drug-induced diarrhea, such as intestinal obstruction, electrolyte disorders, or severe renal insufficiency.
• Any other reason the investigator considers inappropriate for enrollment

Sponsors & Collaborators

• Zhang Yanli: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Head of Gastroenterology

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 1, 2024
• Study Start: December 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)