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Optimized Regimen for High-Risk Populations with Inadequate Bowel Preparation Among Han and Tibetan Ethnicities at Different Altitudes: Efficacy of Sodium Sulfate, Magnesium Sulfate, and Potassium Sulfate Oral Concentrated Solution Combined with Lactulose:A Prospective, Multicenter, Randomized Controlled Trial

Optimized Regimen for High-Risk Populations with Inadequate Bowel Preparation Among Han and Tibetan Ethnicities at Different Altitudes: Efficacy of Sodium Sulfate, Magnesium Sulfate, and Potassium Sulfate Oral Concentrated Solution Combined with Lactulose:A Prospective, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128881
Enrollment
Unknown
Registered
2026-07-27
Start date
2026-07-27
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Colorectal adenoma,carcinoma in situ, adenocarcinoma

Interventions

Monotherapy group:Bowel preparation with Oral Sulfate Solution alone.
Combination group:Bowel preparation using lactulose and Oral Sulfate Solution

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Signed written informed consent approved by the Ethics Committee. 2. Subjects with chronological age between 18 years (inclusive) and 75 years (inclusive), regardless of gender. 3. Self-identified and registered ethnicity as Han or Tibetan. 4. Subjects undergoing colonoscopy for clinical indications. 5. Presence of at least one risk factor for inadequate bowel preparation: (1) Chronic constipation; (2) BMI > 25 kg/m^2; (3) Age > 70 years; (4) History of diabetes mellitus, Parkinson's disease, stroke, or spinal cord injury; (5) Use of tricyclic antidepressants or narcotics.

Exclusion criteria

Exclusion criteria: 1.Refusal to sign or failure to provide informed consent. 2.Use of other medications for bowel preparation. 3.Pregnancy or lactation. 4.Therapeutic colonoscopy, such as polypectomy. 5.Hypersensitivity to any component of sodium magnesium potassium sulfate. 6.Congestive heart failure, severe dehydration, inflammatory bowel disease, known or suspected gastrointestinal perforation, toxic colitis or toxic megacolon, known or suspected intestinal obstruction, known or suspected gastrointestinal obstruction or stricture, gastric emptying disorder, or ascites. 7.Previous colorectal surgery resulting in altered colorectal anatomy unsuitable for bowel preparation quality assessment using the Boston Bowel Preparation Scale (BBPS). 8.Emergency colonoscopy. 9.Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m^2). 10.Subjects deemed unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
bowel preparation success rate;

Secondary

MeasureTime frame
Patient Compliance, Tolerability, and Subjective Feedback;Defecation Characteristics and Intestinal Evacuation Kinetics;Advanced Adenoma Detection Rate;Intraluminal Bubble Elimination Efficacy Assessment;Detection Efficacy Analysis by Adenoma Size;Predictors of Adequate Bowel Preparation;Right-Sided Colon Cleansing Adequacy Rate;Adenoma Detection Rate;The correlation between defecation status and the cleanliness of bowel preparation;

Countries

China

Contacts

Public ContactBin Chuxuan

Bejing Tongren Hospital, Capital Medical Uniersity

cxbin911@126.com+86 10 5853 3225

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026