Bowel PreparationNCT04776733
Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation
A study testing prepackaged semisolid nutritional formulations and restricted diet 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, the investigators will compare prepackaged semisolid nutritional formulations and restricted diet. 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?
- prepackaged semisolid nutritional formulations and restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Oct 2021
- 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;
- History of colorectal resection；
- Patients with diabetes.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang, 315010
Lie min Ruan, MD, +86-574-87085111, master@nbdyyy.com
About this study
Official title: Comparing the Efficacy and Tolerability of a Prepackaged Semisolid Nutritional Formulations With a Restricted Diet for Colonoscopy Preparation: A Randomized Clinical Trial.
In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, the investigators will compare prepackaged semisolid nutritional formulations and restricted diet. The aim was to demonstrate that prepackaged semisolid nutritional formulations is not inferior in overall quality of intestinal preparation to restricted diet in subjects undergoing colonoscopy.
- Conditions
- Bowel Preparation
- Being tested
- prepackaged semisolid nutritional formulations, restricted diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prepackaged semisolid nutritional formulationsOther
The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation.
On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast.
restricted dietOther
The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation.
On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast.
| Study group | Role | What they receive |
|---|---|---|
| prepackaged group | Experimental | All colonoscopy were performed in the afternoon. The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening.
On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast. 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: Other: prepackaged semisolid nutritional formulations |
| restricted diet group | Active comparator | All colonoscopy were performed in the afternoon. The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening.
On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast. 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: Other: restricted diet |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
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
- NCT04776733
- Sponsor's protocol ID
- AHE 1.0
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Tolerability of a Prepackaged Semisolid Nutritional Formulations With a Restricted Diet for Colonoscopy Preparation: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04776733
- Acronym / sponsor ID
- AHE 1.0
- Conditions
- Bowel Preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 2 Mar 2021 (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, the investigators will compare prepackaged semisolid nutritional formulations and restricted diet. The aim was to demonstrate that prepackaged semisolid nutritional formulations is not inferior in overall quality of intestinal preparation to restricted diet in subjects undergoing colonoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prepackaged group | Experimental | Other: prepackaged semisolid nutritional formulationsAll colonoscopy were performed in the afternoon. The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening. On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast. 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. |
| restricted diet group | Active comparator | Other: restricted dietAll colonoscopy were performed in the afternoon. The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation. All the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min in the evening. On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast. 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 (11 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 |
|---|---|---|
| prepackaged semisolid nutritional formulationsThe day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation. On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast. | Other | prepackaged group |
| restricted dietThe day before the colonoscopy: restricted diet prepared by patients were used for diet preparation. On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast. | Other | restricted diet group |
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prepackaged semisolid nutritional formulations and restricted diet 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 11 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 8 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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?
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 8 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.