Clinical trial NCT06339697: Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy
Official title: Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Polyp
Cathartic Colon
Keywords: bowel preparation
gut microbiome
Cathartics
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: gut microbiome-taxonomy
timeFrame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
measure: gut microbiome-heatmap
timeFrame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
measure: gut microbiome-Alpha Diversity
timeFrame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
measure: gut microbiome-Beta Diversity
timeFrame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
measure: gut microbiome-Functional predictions
timeFrame: Before bowel preparation, 7 days after bowel preparation, 14 days after bowel preparation
Secondary outcomes:
measure: Age
timeFrame: Before bowel preparation
measure: Gender
timeFrame: Before bowel preparation
measure: Height
timeFrame: Before bowel preparation
measure: Weight
timeFrame: Before bowel preparation
measure: BMI
timeFrame: Before bowel preparation
measure: Whether the enrollee is a smoker
timeFrame: Before bowel preparation
measure: Whether the enrollee is a drinker
timeFrame: Before bowel preparation
measure: Evaluation of the effectiveness of intestinal cleansing Evaluation of the effectiveness of intestinal cleansing
timeFrame: Within 24 hours after bowel preparation
measure: Gastrointestinal Symptom Score
timeFrame: Within 2 weeks after bowel preparation
measure: adverse event
timeFrame: Within 2 weeks after bowel preparation
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: