Evaluating sodium phosphate powder for intestinal preparation in older adults

A Prospective, Multicenter, Randomized Controlled Clinical Trial on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in the Population Aged 50 to 70 Years Old

This study is testing if sodium phosphate powder is a safe and effective way to prepare older adults for a colonoscopy compared to other methods.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 50 Years to 70 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06652906 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of sodium phosphate powder for intestinal preparation in individuals aged 50 to 70 years. It is a prospective, multicenter, randomized controlled trial involving 362 participants across 8 centers. The primary goal is to assess the effectiveness of the preparation method as determined by the Boston intestinal preparation score, while secondary objectives include evaluating patient tolerance and the impact on lesion detection during colonoscopy. Participants will be randomly assigned to receive either sodium phosphate powder or an alternative preparation method.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 70 who are planning to undergo a colonoscopy and have no contraindications for the procedure.

Not a fit: Patients with a history of colorectal surgery, severe electrolyte disorders, or active gastrointestinal bleeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and effectiveness of intestinal preparation for colonoscopy in older adults.

How similar studies have performed: Previous studies have shown varying degrees of success with similar intestinal preparation methods, but this specific approach with sodium phosphate powder is being evaluated for the first time in this age group.

Eligibility criteria

Inclusion Criteria:

1. Age 50 to 70 years old, gender unlimited
2. No contraindications for colonoscopy examination, planned to undergo colonoscopy examination in the near future
3. Agree to participate in this study

Exclusion Criteria:

1. Patients with a history of colorectal surgery (resection of malignant tumors, resection of rectal perforation, etc.)
2. Electrolyte disorders and hemodialysis patients
3. Patients with active lower gastrointestinal bleeding
4. Patients with abnormal coagulation function
5. Concomitant severe primary diseases such as lung, liver, kidney, and hematopoietic system, liver function ALT AST exceeds the upper limit of the reference value by 1.5 times, or Cr exceeds the upper limit of the reference value
6. Merge other diseases that may affect the efficacy judgment or pose a significant risk, such as acute inflammatory bowel disease, colon cancer, intussusception, volvulus, intestinal obstruction, peritonitis, ascites, stubborn constipation, etc
7. Patients with mental illness and severe neurosis
8. Patients known to have allergies to the investigational or control drugs
9. Participated in other clinical researchers within one month
10. Researchers believe that there are other situations that are not suitable for inclusion, and patients are unwilling to be included in the study

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Peng Yan

Conditions Physical Examination