Effectiveness of Mannitol Versus Polyethylene Glycol Electrolyte Dispersion as a Salve for Patients With Inadequate Bowel Preparation: a Randomized Controlled Clinical Trial

NCT05912114 | Unknown

• 1 other identifier: MPEG1.0
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with inadequate bowel preparation, current guidelines recommend either remedial measures or rescheduling the endoscopy, but previous surveys have found that approximately 30% of patients do not follow medical advice to reschedule the examination if it is rescheduled, while those who take remedial measures on the same day are more compliant, so remedial measures may be a better option than rescheduling the examination. As for the remedy regimen, it has been demonstrated that oral PEG is superior to the enema regimen in terms of bowel cleansing, but PEG is very resistant to be taken by most patients due to its poor taste and the larger doses required, resulting in poor bowel preparation and poor compliance. In contrast, oral mannitol has the advantages of small dose and good taste, and patient compliance may be higher.

Conditions

Bowel Cleansing; Good Taste

Outcome Measures

Primary Outcomes (1)

• Bowel cleanliness

  The BBPS scoring method, defined as a score of ≥2 for each bowel segment, was used to consider the preparation adequate.

  1 hour

Secondary Outcomes (1)

• Patients' feelings

  1 hour

Other Outcomes (1)

• Patients' willingness to take such measures again.

  1 hour

Study Arms (2)

Mannitol

EXPERIMENTAL

Use of oral 1L Mannitol for remediation of intestinal uncleanliness

Drug: Mannitol

Polyethylene glycol electrolyte

ACTIVE COMPARATOR

Use of oral 1L PEG for remediation of intestinal uncleanliness

Drug: Polyethylene glycol electrolyte

Interventions

Mannitol DRUG

Mannitol, as an osmotic laxative, increases the colloid osmotic pressure in the intestinal lumen, which results in a hyperosmolar state in the intestine, thus allowing easy elimination of stools.

Mannitol

Polyethylene glycol electrolyte DRUG

Polyethylene glycol electrolyte is an inert polymer that cannot be absorbed by the body itself. Due to its high permeability, it retains water in the intestinal tract, increasing the amount of fluid retained in the intestine and softening the stool, thus acting as a diuretic.

Polyethylene glycol electrolyte

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years with a pre-first colonoscopy bowel cleanliness of less than 2 points in any segment of the bowel.

You may not qualify if:

• \- (1) Pregnant women. (2) History of colorectal surgery. (3) Patients with acute exacerbation of inflammatory bowel disease. (4) Patients with severe medical conditions that make them unsuitable for colonoscopy.
• (5) Patients with known allergy to mannitol/PEG. (6) Patients who refuse to sign the informed consent form.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo first hospital

Ningbo, Zhejiang, 315000, China

RECRUITING

Related Publications (1)

• Zheng S, Xu Z, Deng F, Wang S, Qian T, Lin P, Wang C, Wang W, Xia Y, Xu L, Zhang Z. Comparing the efficacy of mannitol and polyethylene glycol in treating patients with poor bowel preparation: a randomized controlled clinical study. Tech Coloproctol. 2025 Dec 24;30(1):15. doi: 10.1007/s10151-025-03243-y.

  PMID: 41444456 DERIVED

MeSH Terms

Interventions

Mannitol; glycoprep

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Central Study Contacts

Lei f Xu

CONTACT

+8613486659126; xulei22@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)