NCT05542810

Brief Summary

In this study, 200 patients were enrolled from 2023.1.1 to 2023.12.31, and were randomly divided into intervention and control groups. The intervention group compared the effectiveness of intestinal preparation in the two groups with sports drinks as a polyethylene glycol solvent and water as a polyethylene glycol solvent in the intervention group, and compared adverse reactions, acceptability of solution taste, time of oral laxatives, willingness to repeat the same intestinal preparation or the willingness to recommend the same intestinal preparation to others.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

September 5, 2022

Last Update Submit

September 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • A prospective randomized trial to compare the effectiveness of sports drink and water as a solvent in polyethylene glycol for colonoscopy

    After drinking, a questionnaire was used to compare the adverse reactions, acceptance, preparation time, and differences in the patient's willingness to prepare again or to recommend the same intestinal preparation method to others, and the results were expressed numerically.

    1year

Study Arms (2)

Sports drinks are polyethylene glycol solvents

EXPERIMENTAL
Combination Product: Use sports drinks as polyethylene glycol solvents

Water is a polyethylene glycol solvent

NO INTERVENTION

Interventions

Using sports drinks as a polyethylene glycol solvent and water as a polyethylene glycol solvent in the control group, the effectiveness of intestinal preparation in the two groups was compared, and the adverse reactions, the acceptability of the solution taste, the timing of oral laxatives, and the willingness to repeat the same intestinal preparation or the willingness to recommend the same intestinal preparation to others were compared.

Sports drinks are polyethylene glycol solvents

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients with gastrointestinal disorders Age 18 to 25 years

You may not qualify if:

  • Those who refuse to drink sports drinks Hypersensitivity to polyethylene glycol pregnant women, patients with suspected intestinal obstruction patients at risk of aspiration or with severe systemic or poorly controlled chronic disease patients with acute or severe disease and coagulation disorders patients with diabetes mellitus patients with a history of abdominal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of gastroenterology

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 15, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 15, 2022

Record last verified: 2022-09