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Comparative study on tolerance and defoaming effect of magnesium sodium potassium sulfate oral concentrated solution and polyethylene glycol combined with simethicone

Comparative study on tolerance and defoaming effect of magnesium sodium potassium sulfate oral concentrated solution and polyethylene glycol combined with simethicone

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110865
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-06-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects undergoing colonoscopy

Interventions

Control group:Polyethylene glycol + Simethicone
Trial group:Concentrated solution of magnesium, sodium and potassium sulfate for oral use

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Between the ages of 18 and 65; 2. There are indications for colonoscopy; 3. Have a clear sense of awareness and the ability to act independently, and can cooperate with the implementation of the intervention. 4. Agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Patients with known or suspected intestinal obstruction or stenosis, active inflammatory bowel disease (e.g. Crohn's disease and ulcerative colitis), known or suspected gastrointestinal perforation, toxic colitis, toxic megacolon, gastric emptying disorders (e.g., gastric weakness, gastric retention); 2.Acute abdominal disease requiring surgery (e.g. acute appendicitis), nausea and vomiting, ascites, history of abdominal surgery (e.g. colostomy, colectomy, gastric bypass, gastric anastomosis); 3.Significant electrolyte disturbances (e.g., hypernatremia, hyponatremia, hyperphosphatremia, hypokalemia, hypocalcemia), dehydration, or electrolyte abnormalities secondary to the use of diuretics or other medications; 4.Severe renal insufficiency (glomerular filtration rate < 30 ml/min/1.73 m^2), hepatic insufficiency or cardiac insufficiency (including heart failure); 5.Impairment of consciousness; 6. Patients who are pregnant, breastfeeding, or who refuse (if they have fertility potential) a pregnancy test. 7. Patients allergic to the ingredients of the preparation (polyethylene glycol, sodium sulfate, potassium sulfate, magnesium sulfate); 8. Patients who are unable to follow the study procedures. 9. Patients who participated in an investigational surgical drug or device study in the past 30 days. 10. Patients who withdraw their consent after completing the baseline procedure.

Design outcomes

Primary

MeasureTime frame
Safety evaluation;Tolerance evaluation;

Secondary

MeasureTime frame
Effectiveness evaluation;

Countries

China

Contacts

Public ContactNian Bixiao

Peking University First Hospital

18611812574@163.com+86 18611812574

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026