Bowel Preparation for ColonoscopyNCT06514989
Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy
A study testing Low-residue full nutrition formula podwer and Self-prepared low-residue diet in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital at 27 sites in China.
Trial summary
Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the… 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 for Colonoscopy
- What is being tested?
- Low-residue full nutrition formula podwer and Self-prepared low-residue diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 757 participants
- Where
- 27 sitesChina
- Study dates
- 1 Jul 2024to 20 Jun 2025
- 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
- adult subjects between the ages of 18 and 75 who were scheduled for screening, monitoring, and diagnostic colonoscopy.
Who cannot join
- severe heart, brain, lung, kidney complications or a history of acute myocardial infarction within six months.
- a history of abdominal or pelvic surgery, BMI > 28 or BMI < 18.5, inflammatory bowel disease, constipation (less than 3 bowel movements in the past week, with strenuous bowel movements, hard stool, small volume), or intestinal obstruction.
- imaging and laboratory tests are highly suspicious of colorectal cancer or warning signs and symptoms of colorectal cancer: blood in the stool, black stool, unexplained anemia and significant weight loss, abdominal mass, and positive digital rectal examination.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites
Ankang Central Hospital
Ankang, Shanxi
the central hospital of Dalian
Dalian, Liaoning
Shengli Oilfield Central Hospital
Dongying, Shandong
Ganzhou People's Hospital
Ganzhou, Jiangxi
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Huizhou Central People's Hospital
Huizhou, Guangdong
Jiangmen Central Hospital
Jiangmen, Guangdong
Shandong Provincial Hospital
Jinan, Shandong
Lu'an People's Hospital
Lu'an, Anhui
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjin, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu
Nanjing Gulou Hospital
Nanjing, Jiangsu
PLA 909 Hospital
Quanzhou, Fujian
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433
Shanghai East Hospital
Shanghai, Shanghai Municipality
East China Hospital, Fudan University
Shanghai
Shanghai Seventh People's Hospital
Shanghai
Northern Theater General Hospital
Shenyang, Liaoning
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
Jiangsu Subei People's Hospital
Yangzhou, Jiangsu
Yibin Second People's Hospital
Yibin, Sichuan
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei
PLA 909 Hospital
Zhangzhou, Fujian
About this study
Official title: Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy: a Multicenter Non-inferiority Randomized Controlled Study
Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Low-residue full nutrition formula podwer, Self-prepared low-residue diet
- Keywords
- Bowel preparation, Low-residue diet, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-residue full nutrition formula podwerDietary supplement
The day before the colonoscopy, subjects were given a low-residue full nutrition formula podwer instead of a traditional self-prepared low-residue diet. Subjects were given 6 packs (60g/pack) pre-packaged FNFP and asked to use the FNFP according to individual needs. The 2 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 1 liter taken 3-5 hours before the 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. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liter taken 4-6 hours before the colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol | Experimental | Not described Receives: Dietary Supplement: Low-residue full nutrition formula podwer |
| Self-prepared low-residue diet combined with 3 liters of polyethylene glycol | Active comparator | Not described 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
Defined as score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale
Measured: Two months
Secondary outcomes (9)
Excellent bowel preparation rate
Measured: Two months
BBPS score (including total score, left colon, transverse colon, and right colon)
Measured: Two months
Aronchick Scale score
Measured: Two months
Bowel preparation completion rate
PEG intake is more than 90% of the requirement
Measured: Two weeks
Subject satisfaction rate
Measured: Two weeks
Colonoscopist satisfaction rate
Measured: Two weeks
Adenoma detection rate
Measured: Four weeks
Polyp detection rate
Measured: Two weeks
Compliance with FNFP
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Mar 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation for ColonoscopyStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Li Zhaoshen, PhD, Study chair, Department of Gastroenterology, Changhai Hospital, Navy Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514989
- Sponsor's protocol ID
- FNFP2024
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy: a Multicenter Non-inferiority Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06514989
- Acronym / sponsor ID
- FNFP2024
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- Bowel preparation, Low-residue diet, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 23 Jul 2024 (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.
Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol | Experimental | Dietary Supplement: Low-residue full nutrition formula podwer |
| Self-prepared low-residue diet combined with 3 liters of polyethylene glycol | Active comparator | Dietary Supplement: Self-prepared low-residue diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult subjects between the ages of 18 and 75 who were scheduled for screening, monitoring, and diagnostic colonoscopy.
Key exclusion criteria (3 listed)
- severe heart, brain, lung, kidney complications or a history of acute myocardial infarction within six months.
- a history of abdominal or pelvic surgery, BMI > 28 or BMI < 18.5, inflammatory bowel disease, constipation (less than 3 bowel movements in the past week, with strenuous bowel movements, hard stool, small volume), or intestinal obstruction.
- imaging and laboratory tests are highly suspicious of colorectal cancer or warning signs and symptoms of colorectal cancer: blood in the stool, black stool, unexplained anemia and significant weight loss, abdominal mass, and positive digital rectal examination.
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 |
|---|---|---|
| Low-residue full nutrition formula podwerThe day before the colonoscopy, subjects were given a low-residue full nutrition formula podwer instead of a traditional self-prepared low-residue diet. Subjects were given 6 packs (60g/pack) pre-packaged FNFP and asked to use the FNFP according to individual needs. The 2 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 1 liter taken 3-5 hours before the colonoscopy. | Dietary supplement | Low-residue nutrition formula podwer combined with 2 liters of polyethylene glycol |
| 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. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liter taken 4-6 hours before the colonoscopy. | Dietary supplement | Self-prepared low-residue diet combined with 3 liters of polyethylene glycol |
Primary outcome
Adequate bowel preparation rate
Time frame: Two months
Defined as score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale
9 secondary outcomes
Excellent bowel preparation rate
Time frame: Two months
BBPS score (including total score, left colon, transverse colon, and right colon)
Time frame: Two months
Aronchick Scale score
Time frame: Two months
Bowel preparation completion rate
Time frame: Two weeks
Subject satisfaction rate
Time frame: Two weeks
Colonoscopist satisfaction rate
Time frame: Two weeks
Adenoma detection rate
Time frame: Four weeks
Polyp detection rate
Time frame: Two weeks
Compliance with FNFP
Time frame: Two weeks
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 Sep 2025.
- 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.
Li Zhaoshen, PhD study chair
Department of Gastroenterology, Changhai Hospital, Navy Medical University
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-residue full nutrition formula podwer and Self-prepared low-residue diet in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital at 27 sites 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 3 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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: Two months). 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 11 Sep 2025.