Colon PolypNCT03943758
a Low-residue Diet for Bowel Preparation
A study testing Prepackaged Low-residue diet and Self-prepared Low-residue diet in people with Colon Polyp and Colorectal Adenoma, run by Changhai Hospital at 1 site in China.
Trial summary
Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colon Polyp, Colorectal Adenoma
- What is being tested?
- Prepackaged Low-residue diet and Self-prepared Low-residue diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 589 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2019to 31 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age is between 18-65.
- Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- Patients who have signed inform consent form
Who cannot join
- subjects who had known or suspected heart failure, stroke or renal failure;
- subjects who had a history of colon surgery or inflammatory bowel disease;
- subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons;
- subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products;
- subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week;
- subjects who had participated in another interventional clinical trial in the previous 60 days;
- pregnant or lactating women and those planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy
Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.
- Conditions
- Colon Polyp, Colorectal Adenoma
- Being tested
- Prepackaged Low-residue diet, Self-prepared Low-residue diet
- Keywords
- Bowel preparation, Polyp, adenoma
- Medical subject headings
- Colonic Polyps, Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepackaged Low-residue dietDietary supplement
Subjects in the prepackaged Low-residue diet group were given 6 packs (60g/pack) pre-packaged formula LRD and asked to use the formula according to individual needs prior to colonoscopy.
Self-prepared Low-residue dietDietary supplement
Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| prepackaged Low-residue diet group | Experimental | The prepackaged Low-residue diet (Maifu Nutrition Technology Co. Ltd, Beijing, China). One package of the prepackaged Low-residue diet contained quantity of heat amounts to 268 kilocalories with 12.0 g of protein, 9.6 g of lipid, and 34.1 g of carbohydrate. Receives: Dietary Supplement: Prepackaged Low-residue diet |
| self-prepared Low-residue group | Active comparator | Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy Receives: Dietary Supplement: Self-prepared Low-residue diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation rate
Boston Bowel Preparation Scale (BBPS) was adopted to evaluate the quality of bowel preparation. Each section of the colon (i.e. the right, the transverse, and the rectosigmoid colon) was rated (0, very poor; 1, poor; 2, good; and 3, very good). Adequate bowel of bowel preparation was defined as a total score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1.
Measured: 30 mins
BBPS scores of the entire colon
The sum of the scores of three bowel segment.
Measured: 30 mins
Secondary outcomes (2)
adenoma detection rate (ADR)
adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
Measured: 30 mins
preparation completion rate
preparation completion rate is the number of patients ingest more than 80% laxative, divided by the total number of patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start10 May 2019
- Primary completion10 Dec 2020
- Study completion31 Dec 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 Colon PolypStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Jinan Military General Hospital, Wuhan TongJi Hospital, Zhejiang University, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University, West China Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943758
- Sponsor's protocol ID
- Low-residue
- Status last verified
- Dec 2021
- First submitted
- 8 May 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan P, Gu L, Zhao S, Wang S, Ma J, Fu H, Chen Y, He S, Tian Z, Xu L, Feng Z, Li Y, Yang Z, Yang L, Wang W, Hou Q, Liu T, Li C, Tian D, Wang X, Gao Y, Shi H, Bai Y, Li Z. Prepackaged formula low-residue diet vs. self-prepared low-residue diet before colonoscopy: A multicenter randomized controlled trial. Front Med (Lausanne). 2023 Mar 24;10:1029493. doi: 10.3389/fmed.2023.1029493. eCollection 2023.
PubMed 37035340
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT03943758
- Acronym / sponsor ID
- Low-residue
- Conditions
- Colon Polyp, Colorectal Adenoma
- Keywords
- Bowel preparation, Polyp, adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Jinan Military General Hospital, Wuhan TongJi Hospital, Zhejiang University, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University, West China Hospital
- Study start
- 10 May 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 May 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.
Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prepackaged Low-residue diet group | Experimental | Dietary Supplement: Prepackaged Low-residue dietThe prepackaged Low-residue diet (Maifu Nutrition Technology Co. Ltd, Beijing, China). One package of the prepackaged Low-residue diet contained quantity of heat amounts to 268 kilocalories with 12.0 g of protein, 9.6 g of lipid, and 34.1 g of carbohydrate. |
| self-prepared Low-residue group | Active comparator | Dietary Supplement: Self-prepared Low-residue dietSubjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose age is between 18-65.
- Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- Patients who have signed inform consent form
Key exclusion criteria (7 listed)
- subjects who had known or suspected heart failure, stroke or renal failure;
- subjects who had a history of colon surgery or inflammatory bowel disease;
- subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons;
- subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products;
- subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week;
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 Low-residue dietSubjects in the prepackaged Low-residue diet group were given 6 packs (60g/pack) pre-packaged formula LRD and asked to use the formula according to individual needs prior to colonoscopy. | Dietary supplement | prepackaged Low-residue diet group |
| Self-prepared Low-residue dietSubjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy. | Dietary supplement | self-prepared Low-residue group |
Primary outcome
Adequate bowel preparation rate
Time frame: 30 mins
Boston Bowel Preparation Scale (BBPS) was adopted to evaluate the quality of bowel preparation. Each section of the colon (i.e. the right, the transverse, and the rectosigmoid colon) was rated (0, very poor; 1, poor; 2, good; and 3, very good). Adequate bowel of bowel preparation was defined as a total score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1.
BBPS scores of the entire colon
Time frame: 30 mins
The sum of the scores of three bowel segment.
2 secondary outcomes
adenoma detection rate (ADR)
Time frame: 30 mins
preparation completion rate
Time frame: 1 day
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 11 Jan 2022.
- Derived from this study: PubMed 37035340Pan P, Gu L, Zhao S, Wang S, Ma J, Fu H, Chen Y, He S, Tian Z, Xu L, Feng Z, Li Y, Yang Z, Yang L, Wang W, Hou Q, Liu T, Li C, Tian D, Wang X, Gao Y, Shi H, Bai Y, Li Z. Prepackaged formula low-residue diet vs. self-prepared low-residue diet before colonoscopy: A multicenter randomized controlled trial. Front Med (Lausanne). 2023 Mar 24;10:1029493. doi: 10.3389/fmed.2023.1029493. eCollection 2023.
- 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.
Zhaoshen Li, M.D. principal investigator
Changhai Hospital
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 Low-residue diet and Self-prepared Low-residue diet in people with Colon Polyp and Colorectal Adenoma, run by Changhai 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: finished, as of the sponsor's last update on 11 Jan 2022. 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?
Adequate bowel preparation rate (time frame: 30 mins). The study lists 2 primary outcomes in all. 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 NCT03943758, 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 11 Jan 2022.