Bowel PreparationNCT04021979
Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG
A study testing Enteral Nutrition Powder Ensure, 1.5L PEG and 2L PEG in people with Bowel Preparation, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Enteral Nutrition Powder Ensure, 1.5L PEG and 2L PEG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Nov 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the age of 18-75year
- Outpatients undergoing colonoscopy
- Informed consent
Who cannot join
- the age >75 years or <18 years
- history of colectomy or bowel obstruction
- severe constipation (defined as stool frequerncy of 3 or less/week)
- current pregnancy or breastfeeding
- BMI >30, diabetes
- known allergies to cleansing agents or ingredients of Enteral nutrition
- inability to follow the oral bowel preparation regimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Bowel Cleansing Regimens（Controlled Dietary Restriction With Enteral Nutrition and 1.5L Polyethylene Glycol vs Controlled Dietary Restriction and 2.0L Polyethylene Glycol）：an Endoscopist-blinded, Prospective Randomized Controlled Trial
This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.
Read the detailed description
Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial，additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food.
We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.
- Conditions
- Bowel Preparation
- Being tested
- Enteral Nutrition Powder Ensure, 1.5L PEG, Self-controlled diet, 2L PEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Nutrition Powder EnsureDietary supplement
Also called Ensure
Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.
1.5L PEGDrug
Also called Hengkangzhengqing
Low volume PEG
Self-controlled dietOther
Self-controlled low residue diet.
2L PEGDrug
Also called Hengkangzhengqing
Normal volume of PEG
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutritional+PEG | Experimental | Enteral Nutritional Powder with low volume 1.5L PEG Receives: Dietary Supplement: Enteral Nutrition Powder Ensure; Drug: 1.5L PEG |
| Self-controlled diet+PEG | Placebo comparator | Self-controlled diet with normal amount of 2L PEG Receives: Other: Self-controlled diet; Drug: 2L PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of bowel preparation
Evaluation of the quality of bowel preparation for each participant by the Ottawa bowel preparation scale(OBPS)，it's a validated scoring system with scores between 0 and 14, where 0 is the best score，The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon.n addition, a score 0-2 is added to indicate the total amount of luminal fluid.
Measured: 1day
Secondary outcomes (5)
patients' satisfaction with the process of bowel preparation
At the end of the procedure, the patients were asked about the satisfaction with the process of bowel preparation. Satisfaction includes bad，not so bad and good.Bad means that the patient is not satisfied with the program, not so bad means that the patient is satisfied with the plan, and good means that the patient is very satisfied with the plan.
Measured: 1day
patients' willingness to have the colonoscopy done again at this facility in the future
It represent participants who wanted to choose the same protocol in the future as they received in this trial.Including yes and no two options, if yes, indicating that the patient is willing to undergo colonoscopy again, if no, indicating that the patient is reluctant to undergo colonoscopy again.
Measured: 1day
comparison with previous experience
If patients with colonoscopy times ≥ 2, they need to compare with previous experience，Including better than last experience, similar to the last experience, and worse than the last experience.
Measured: 1day
adverse events
It represent the incidence of abdominal cramping, bloating, nausea/vomiting after intake of PEG and/or enteral nutrition was compared.
Measured: 1day
Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol
It represented the percentage of patients who thinks the protocol is easy to use.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Nov 2019 (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
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongpeng Lu, master, Principal investigator, Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021979
- Sponsor's protocol ID
- 2017-R035
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Bowel Cleansing Regimens（Controlled Dietary Restriction With Enteral Nutrition and 1.5L Polyethylene Glycol vs Controlled Dietary Restriction and 2.0L Polyethylene Glycol）：an Endoscopist-blinded, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04021979
- Acronym / sponsor ID
- 2017-R035
- Conditions
- Bowel Preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 16 Jul 2019 (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.
This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.
Detailed description
Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial，additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food.
We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutritional+PEG | Experimental | Dietary Supplement: Enteral Nutrition Powder Ensure, Drug: 1.5L PEGEnteral Nutritional Powder with low volume 1.5L PEG |
| Self-controlled diet+PEG | Placebo comparator | Other: Self-controlled diet, Drug: 2L PEGSelf-controlled diet with normal amount of 2L PEG |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the age of 18-75year
- Outpatients undergoing colonoscopy
- Informed consent
Key exclusion criteria (7 listed)
- the age >75 years or <18 years
- history of colectomy or bowel obstruction
- severe constipation (defined as stool frequerncy of 3 or less/week)
- current pregnancy or breastfeeding
- BMI >30, diabetes
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 |
|---|---|---|
| Enteral Nutrition Powder EnsureAlso: EnsureEnteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy. | Dietary supplement | Enteral Nutritional+PEG |
| 1.5L PEGAlso: HengkangzhengqingLow volume PEG | Drug | Enteral Nutritional+PEG |
| Self-controlled dietSelf-controlled low residue diet. | Other | Self-controlled diet+PEG |
| 2L PEGAlso: HengkangzhengqingNormal volume of PEG | Drug | Self-controlled diet+PEG |
Primary outcome
the quality of bowel preparation
Time frame: 1day
Evaluation of the quality of bowel preparation for each participant by the Ottawa bowel preparation scale(OBPS)，it's a validated scoring system with scores between 0 and 14, where 0 is the best score，The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon.n addition, a score 0-2 is added to indicate the total amount of luminal fluid.
5 secondary outcomes
patients' satisfaction with the process of bowel preparation
Time frame: 1day
patients' willingness to have the colonoscopy done again at this facility in the future
Time frame: 1day
comparison with previous experience
Time frame: 1day
adverse events
Time frame: 1day
Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Hongpeng Lu, master principal investigator
Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Nutrition Powder Ensure, 1.5L PEG and 2L PEG 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 3 inclusion and 7 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 16 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Xu, PhD (+86-0574-87089840, xulei22@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the quality of bowel preparation (time frame: 1day). 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 16 Jul 2019.