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

NCT ID: NCT06339697

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-06-30

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.

Detailed Description

Good and adequate bowel preparation is essential for colonoscopy, especially in patients requiring endoscopic treatment, and the role of bowel purgatives and their safety for patients has been extensively studied. There are several laxatives available in clinical practice, the most widely used being electrolyte-supplemented polyethylene glycol (PEG) solutions, and other types of laxatives such as compound sodium picosulfate (SP) have been developed subsequently.

When a large amount of laxative passes through the intestine, many microorganisms are removed from the intestine. Thus leading to significant changes in the composition of the intestinal microbiota during intestinal cleansing. There is no consensus on how gut cleansing affects the gut microbiome.

There are no studies exploring whether there are differences in the effects of different types of laxatives on the human gut microbiome. In this study, focusing on patients diagnosed with colon polyps, the investigators explored the effects on the composition, evolution, recovery and functional pathways of the patients' gut microbiome after the use of different types of laxatives and endoscopic treatment.

Conditions

Colon Polyp; Cathartic Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

compounded polyethylene glycol electrolyte dispersions

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

compounded sodium pico-sulfate

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhang Yanli

OTHER

Sponsor Role: lead

Responsible Party

Zhang Yanli

Deputy Head of Gastroenterology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022-KY-233

Identifier Type: -

Identifier Source: org_study_id