Bowel PreparationEarly Phase 1NCT05542810
Compare the Effectiveness of Sports Drink and Water as a Solvent in Polyethylene Glycol for Colonoscopy
A Early Phase 1 study testing Use sports drinks as polyethylene glycol solvents in people with Bowel Preparation, run by GanHuoye.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Use sports drinks as polyethylene glycol solvents
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospitalized patients with gastrointestinal disorders Age 18 to 25 years
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Trial to Compare the Effectiveness of Sports Drink and Water as a Solvent in Polyethylene Glycol for Colonoscopy
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.
- Conditions
- Bowel Preparation
- Being tested
- Use sports drinks as polyethylene glycol solvents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use sports drinks as polyethylene glycol solventsCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Sports drinks are polyethylene glycol solvents | Experimental | Not described Receives: Combination Product: Use sports drinks as polyethylene glycol solvents |
| Water is a polyethylene glycol solvent | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GanHuoye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GanHuoye, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542810
- Sponsor's protocol ID
- Guangzhou Medical University
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial to Compare the Effectiveness of Sports Drink and Water as a Solvent in Polyethylene Glycol for Colonoscopy
- ClinicalTrials.gov ID
- NCT05542810
- Acronym / sponsor ID
- Guangzhou Medical University
- Conditions
- Bowel Preparation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GanHuoyeUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sports drinks are polyethylene glycol solvents | Experimental | Combination Product: Use sports drinks as polyethylene glycol solvents |
| Water is a polyethylene glycol solvent | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients with gastrointestinal disorders Age 18 to 25 years
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use sports drinks as polyethylene glycol solventsUsing 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. | Combination product | Sports drinks are polyethylene glycol solvents |
Primary outcome
A prospective randomized trial to compare the effectiveness of sports drink and water as a solvent in polyethylene glycol for colonoscopy
Time frame: 1year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
Related trials for Bowel Preparation
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Use sports drinks as polyethylene glycol solvents in people with Bowel Preparation, run by GanHuoye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gan Huoye (13927688350, gzyghy04@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A prospective randomized trial to compare the effectiveness of sports drink and water as a solvent in polyethylene glycol for colonoscopy (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.