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

2022-KY-233

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.

2022-12-01

2023-06-30

2023-06-30

Completed

Early phase I

194

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 194, 'type': 'ACTUAL'}}

2024-04-01