Bowel PreparationNCT04247386
Mizone vs Water for Bowel Preparation.
A study testing PEG-Mizone and PEG-ELS in people with Bowel Preparation, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with PEG-ELS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- PEG-Mizone and PEG-ELS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2019to 31 Aug 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.
Who cannot join
- Patients with constipation;
- Patients with congestive heart failure;
- Patients with a history of kidney disease;
- Patients with a history of poor intestinal preparation;
- Pregnant / lactating women;
- Patients without informed consent;
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- Allergic or intolerant to any research drug;
- Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;
- Patients with a history of inflammatory bowel disease;
- Significant electrolyte anomalies, including phosphorus, sodium, potassium, calcium, chloride and magnesium;
- History of colorectal resection；
- Patients with diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study
In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with PEG-ELS. The aim was to demonstrate that polyethylene glycol electrolyte powder (PEG-4000) and Mizone is not inferior in overall quality of intestinal preparation to PEG-ELS in subjects undergoing colonoscopy.
- Conditions
- Bowel Preparation
- Being tested
- PEG-Mizone, PEG-ELS
- Keywords
- bowel preparation quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-MizoneDrug
The evening before the colonoscopy:60gPEG-4000 was mixed with 0.6LMizone and 0.4L water.
On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 1.2LMizone and 0.8L water.
PEG-ELSDrug
The evening before the colonoscopy:60gPEG-4000 was mixed with 1L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 2L water.
| Study group | Role | What they receive |
|---|---|---|
| PEG-Mizone prep | Experimental | The evening before the colonoscopy: The patients who are randomized to the " PEG-Mizone prep " arm will drink single dose of 60g Polyethylene Glycol (PEG-4000) with 0.6L Mizone+0.4L water at a rate of 250 ml every 15 min.
On the day of the colonoscopy: The patients who are randomized to the " PEG-Mizone prep " arm will drink single dose of 120g Polyethylene Glycol (PEG-4000) with 1.2L Mizone+0.8L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Receives: Drug: PEG-Mizone |
| PEG-ELS prep | Active comparator | The evening before the colonoscopy: In the PEG-ELS prep group, all the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min.
On the day of the colonoscopy: all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Receives: Drug: PEG-ELS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bowel Preparation
The OBPS，a scoring system with scores between 0 and 14, where 0 is the best score，divides the colon into 3 segments (right, transverse and rectosigmoid colon); each is scored from 0-4 (0=excellent, If it is necessary to suction liquid stool to adequately see the colonic wall, a score of 2 (fair) is given; if it is necessary to wash and to suction, a score of 3 (poor) is given. The remaining scores fall into place around these anchors. ). A score 0-2 is added to indicate the total amount of luminal fluid.(0=The total amount of fluid in the colon is very small,1=a moderate volume of fluid overall in the colon,2=a large volume of fluid overall in the colon)
Measured: 1 Day of colonoscopy
Secondary outcomes (2)
Adverse event rate
Including Electrolyte disorders requiring clinical treatment, etc.
Measured: 3 days
patient tolerability of bowel preparation
On the day of the patient's colonoscopy, each patient will complete another form regarding their bowel preparation experience with a modified 5-point Likert scale for ease of use (score 5-1: very easy, easy, tolerable, difficult or very difficult).
Measured: 1 Day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start25 Dec 2019
- Primary completion1 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247386
- Sponsor's protocol ID
- PEG-1.0
- Status last verified
- Sep 2020
- First submitted
- 21 Dec 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Z, Gao H, Yuan X, Liu C, Bao Z, Yu S, Xie H, Wang W, Xie J, Xu L. The efficacy and tolerability of sports drink versus water in bowel preparations: a randomised controlled study. Trials. 2022 Aug 26;23(1):709. doi: 10.1186/s13063-022-06658-2.
PubMed 36028915
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04247386
- Acronym / sponsor ID
- PEG-1.0
- Conditions
- Bowel Preparation
- Keywords
- bowel preparation quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 30 Jan 2020 (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 order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with PEG-ELS. The aim was to demonstrate that polyethylene glycol electrolyte powder (PEG-4000) and Mizone is not inferior in overall quality of intestinal preparation to PEG-ELS in subjects undergoing colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-Mizone prep | Experimental | Drug: PEG-MizoneThe evening before the colonoscopy: The patients who are randomized to the " PEG-Mizone prep " arm will drink single dose of 60g Polyethylene Glycol (PEG-4000) with 0.6L Mizone+0.4L water at a rate of 250 ml every 15 min. On the day of the colonoscopy: The patients who are randomized to the " PEG-Mizone prep " arm will drink single dose of 120g Polyethylene Glycol (PEG-4000) with 1.2L Mizone+0.8L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. |
| PEG-ELS prep | Active comparator | Drug: PEG-ELSThe evening before the colonoscopy: In the PEG-ELS prep group, all the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min. On the day of the colonoscopy: all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.
Key exclusion criteria (12 listed)
- Patients with constipation;
- Patients with congestive heart failure;
- Patients with a history of kidney disease;
- Patients with a history of poor intestinal preparation;
- Pregnant / lactating women;
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 |
|---|---|---|
| PEG-MizoneThe evening before the colonoscopy:60gPEG-4000 was mixed with 0.6LMizone and 0.4L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 1.2LMizone and 0.8L water. | Drug | PEG-Mizone prep |
| PEG-ELSThe evening before the colonoscopy:60gPEG-4000 was mixed with 1L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 2L water. | Drug | PEG-ELS prep |
Primary outcome
Quality of Bowel Preparation
Time frame: 1 Day of colonoscopy
The OBPS，a scoring system with scores between 0 and 14, where 0 is the best score，divides the colon into 3 segments (right, transverse and rectosigmoid colon); each is scored from 0-4 (0=excellent, If it is necessary to suction liquid stool to adequately see the colonic wall, a score of 2 (fair) is given; if it is necessary to wash and to suction, a score of 3 (poor) is given. The remaining scores fall into place around these anchors. ). A score 0-2 is added to indicate the total amount of luminal fluid.(0=The total amount of fluid in the colon is very small,1=a moderate volume of fluid overall in the colon,2=a large volume of fluid overall in the colon)
2 secondary outcomes
Adverse event rate
Time frame: 3 days
patient tolerability of bowel preparation
Time frame: 1 Day of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 36028915Zhang Z, Gao H, Yuan X, Liu C, Bao Z, Yu S, Xie H, Wang W, Xie J, Xu L. The efficacy and tolerability of sports drink versus water in bowel preparations: a randomised controlled study. Trials. 2022 Aug 26;23(1):709. doi: 10.1186/s13063-022-06658-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-Mizone and PEG-ELS in people with Bowel Preparation, run by Ningbo No. 1 Hospital at 1 site in China.
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 12 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: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Bowel Preparation (time frame: 1 Day of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04247386, which also lists 1 linked publication.
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 16 Sep 2020.