Bowel PreparationNCT05609591
Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children
A study testing Liquid diet group, Enteral nutrition group and Low residual diet group in people with Bowel Preparation, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Liquid diet group, Enteral nutrition group and Low residual diet group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2022to 30 Jul 2024
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 2 years～18 years old
- Children under anesthesia for elective colonoscopy with bowel preparation
Who cannot join
- Children who are unable to perform bowel preparation with polyethylene glycol-4000
- Children whose guardians refuse to participate in this study
- Children who are unable to eat orally
- Children with stomy
Trial locations and contacts
1 site in 1 country.
China1 site
Children'S Hospital of Fudan University
Shanghai, Shanghai Municipality, 201100
About this study
Official title: Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children : A Randomized Clinical Trial
To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children
Read the detailed description
The accuracy of endoscopic diagnosis and treatment of safety depends largely on the intestinal cleaning quality. Qualified bowel preparation is a prerequisite for clear vision during colonoscopy. Presently, the common diet for children before colonoscopy in China is a liquid or low residual diet. The liquid and low residual diet often have poor taste and satiety, often resulting in poor compliance of children, especially young children, who are often unwilling to eat a liquid diet, resulting in insufficient caloric supply and unstable blood glucose during bowel preparation. Enteral formula as a kind of high-energy and low-fiber diet has been applied in clinical practice. Currently, there is no comparison between liquid diet, low-residue diet, and enteral formulas in children's bowel preparation in China. Dietary restriction is an indispensable part to ensure the success of the bowel preparation program. There is an urgent need to conduct research on the application of various dietary programs in children's bowel preparation before colonoscopy in China. In order to provide high-quality evidence for the bowel preparation diet program for children.
- Conditions
- Bowel Preparation
- Being tested
- Liquid diet group, Enteral nutrition group, Low residual diet group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid diet groupDietary supplement
Fluid diet including juice, rice soup, filtered vegetable juice/broth, lotus root powder and milk and egg soup were given to children for bowel preparation.
Enteral nutrition groupDietary supplement
100% short peptide enteral nutrition are given to children for bowel preparation
Low residual diet groupDietary supplement
Low residua diet included gruel with grain only, peeled carrot, white gourd, powdered skin, tofu, vegetable, mud and fruit. were given to children for bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| Liquid diet group | Experimental | From 8:00 on the day before colonoscopy, oral fluids including juice, rice soup, filtered vegetable juice/broth, lotus root powder and milk and egg soup were taken to ensure energy intake and blood glucose stability. The fasting starts at 9:00 AM on the day of colonoscopy. Receives: Dietary Supplement: Liquid diet group |
| Enteral nutrition group | Experimental | Oral administration of 100% short peptide enteral nutrition preparation from 8:00 on the day before colonoscopy. The fasting starts at 9:00 AM on the day of colonoscopy. Receives: Dietary Supplement: Enteral nutrition group |
| Low residual diet group | Experimental | From 8:00 on the day before colonoscopy, the patients were given oral administration of less residue food included gruel with grain only, peeled carrot, white gourd, powdered skin, tofu, vegetable, mud and fruit. The fasting starts at 9:00 AM on the day of colonoscopy. Receives: Dietary Supplement: Low residual diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale score
The nurse will use the Boston Bowel Preparation Scale colonoscopic to evaluate the intestinal fecal trait under colonoscope and record in the case report form. The right side (cecum and ascending colon), transverse colon (hepatic flexion and splenic flexion) and left side (descending colon, sigmoid colon and rectum) were scored respectively. 0 score: a large amount of solid stool remains in the colon; 1 score: liquid and semi-solid feces exist in some intestinal segments; 2 points: a small amount of feces remains, but does not affect the colonoscopic field of view; 3 points: no solid liquid fecal residue in the colon.
The total score of the scale is 9 points, 8-9 points is excellent; 6-7 points is good; 4-5 points is average; 0-3 points is Poor.
Measured: After the children finish their bowel preparation, an average of 5 minutes
Secondary outcomes (5)
Revised-Bristol Stool Form Scale score
The fecal traits are recorded in the case report form by the nurse with a Revised-Bristol Stool Form Scale according to the stool characteristics of children. The score was 8 points in order: 8 points: clear water stool, no residue; 7 points: turbid water sample, with or without a small amount of fecal residue; 6 points: velvet, unclear edge, mushy stool; 5 points: soft mass, clear edge; 4 points: like sausage or snake, smooth and soft; 3 points: sausage-shaped, but with cracks on the surface; 2 points: sausage-shaped, but in chunks; 1 point: scattered hard pieces, like nuts. A score of 8 indicates that the naked eye assessment of bowel preparation is qualified, and colonoscopy can be performed directly. A score of 6-7 indicates that bowel preparation is not sufficient, and a colonoscopy should be performed at the selected day. ≤5 points is recommended to cancel the colonoscopy on the same day and extend the bowel preparation time.
Measured: After the children finish their bowel preparation, an average of 5 minutes.
The times of enema
Children with substandard bowel preparation before colonoscopy were going to undergo enemas to ensure the visual clarity of colonoscopy. The times of enema will be recorded by the nurse who perform the enema in the case report form.
Measured: After the children finish their enema, an average of 1 minute.
Number of defecation during bowel preparation
The number of defecation during bowel preparation will be recorded in the case report form by the nurse.
Measured: After the children finish their bowel preparation, an average of 1 minute.
Medication compliance
Children who complete less than 30% polyethylene glycol 4000 (PEG-4000) are defined as having poor compliance, completing 30%~60% PEG-4000 is fair compliance, completing 60%~80% PEG-4000 is good compliance, and great than 80% PEG-4000 is excellent compliance. The nurse will evaluate children's compliance according to their completion of PEG-4000 and record it in the case report form.
Measured: After the children finish their bowel preparation, an average of 3 minutes.
Adverse reactions of bowel preparation
Acceptable safety indicators: occasional and mild nausea, vomiting, abdominal pain, abdominal distension; a few sporadic rashes; perianal discomfort.
Indicators need to be closely monitored: frequent and severe vomiting, abdominal pain, abdominal distension, blood in the stool; Widespread or diffuse rash.
Unacceptable indicators: fecal incontinence, dehydration, and electrolyte disturbance; intestinal perforation; shock.
All the adverse reactions will be observed and recorded in the case report form by the nurse.
Measured: During children's bowel preparation, an average of 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start9 Nov 2022
- Primary completion30 Jan 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Gu, 3, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609591
- Sponsor's protocol ID
- FNF20210820
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2022
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will not make individual participant data available to other reseasrchers
Publications
Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
PubMed 15758907Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. doi: 10.1111/j.1365-2036.2006.03212.x.
PubMed 17269992Barkun A, Chiba N, Enns R, Marcon M, Natsheh S, Pham C, Sadowski D, Vanner S. Commonly used preparations for colonoscopy: efficacy, tolerability, and safety--a Canadian Association of Gastroenterology position paper. Can J Gastroenterol. 2006 Nov;20(11):699-710. doi: 10.1155/2006/915368.
PubMed 17111052Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.
PubMed 29112090Wu R, Ji WY, Yang C, Zhan Q. A Systematic Review and Meta-Analysis of Low-Residue Diet Versus Clear Liquid Diet: Which Is Better for Bowel Preparation Before Colonoscopy? Gastroenterol Nurs. 2021 Sep-Oct 01;44(5):341-352. doi: 10.1097/SGA.0000000000000554.
PubMed 34238885
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05609591
- Acronym / sponsor ID
- FNF20210820
- Conditions
- Bowel Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Nov 2022 (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.
To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children
Detailed description
The accuracy of endoscopic diagnosis and treatment of safety depends largely on the intestinal cleaning quality. Qualified bowel preparation is a prerequisite for clear vision during colonoscopy. Presently, the common diet for children before colonoscopy in China is a liquid or low residual diet. The liquid and low residual diet often have poor taste and satiety, often resulting in poor compliance of children, especially young children, who are often unwilling to eat a liquid diet, resulting in insufficient caloric supply and unstable blood glucose during bowel preparation. Enteral formula as a kind of high-energy and low-fiber diet has been applied in clinical practice. Currently, there is no comparison between liquid diet, low-residue diet, and enteral formulas in children's bowel preparation in China. Dietary restriction is an indispensable part to ensure the success of the bowel preparation program. There is an urgent need to conduct research on the application of various dietary programs in children's bowel preparation before colonoscopy in China. In order to provide high-quality evidence for the bowel preparation diet program for children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liquid diet group | Experimental | Dietary Supplement: Liquid diet groupFrom 8:00 on the day before colonoscopy, oral fluids including juice, rice soup, filtered vegetable juice/broth, lotus root powder and milk and egg soup were taken to ensure energy intake and blood glucose stability. The fasting starts at 9:00 AM on the day of colonoscopy. |
| Enteral nutrition group | Experimental | Dietary Supplement: Enteral nutrition groupOral administration of 100% short peptide enteral nutrition preparation from 8:00 on the day before colonoscopy. The fasting starts at 9:00 AM on the day of colonoscopy. |
| Low residual diet group | Experimental | Dietary Supplement: Low residual diet groupFrom 8:00 on the day before colonoscopy, the patients were given oral administration of less residue food included gruel with grain only, peeled carrot, white gourd, powdered skin, tofu, vegetable, mud and fruit. The fasting starts at 9:00 AM on the day of colonoscopy. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 2 years～18 years old
- Children under anesthesia for elective colonoscopy with bowel preparation
Key exclusion criteria (4 listed)
- Children who are unable to perform bowel preparation with polyethylene glycol-4000
- Children whose guardians refuse to participate in this study
- Children who are unable to eat orally
- Children with stomy
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 |
|---|---|---|
| Liquid diet groupFluid diet including juice, rice soup, filtered vegetable juice/broth, lotus root powder and milk and egg soup were given to children for bowel preparation. | Dietary supplement | Liquid diet group |
| Enteral nutrition group100% short peptide enteral nutrition are given to children for bowel preparation | Dietary supplement | Enteral nutrition group |
| Low residual diet groupLow residua diet included gruel with grain only, peeled carrot, white gourd, powdered skin, tofu, vegetable, mud and fruit. were given to children for bowel preparation | Dietary supplement | Low residual diet group |
Primary outcome
Boston Bowel Preparation Scale score
Time frame: After the children finish their bowel preparation, an average of 5 minutes
The nurse will use the Boston Bowel Preparation Scale colonoscopic to evaluate the intestinal fecal trait under colonoscope and record in the case report form. The right side (cecum and ascending colon), transverse colon (hepatic flexion and splenic flexion) and left side (descending colon, sigmoid colon and rectum) were scored respectively. 0 score: a large amount of solid stool remains in the colon; 1 score: liquid and semi-solid feces exist in some intestinal segments; 2 points: a small amount of feces remains, but does not affect the colonoscopic field of view; 3 points: no solid liquid fecal residue in the colon. The total score of the scale is 9 points, 8-9 points is excellent; 6-7 points is good; 4-5 points is average; 0-3 points is Poor.
5 secondary outcomes
Revised-Bristol Stool Form Scale score
Time frame: After the children finish their bowel preparation, an average of 5 minutes.
The times of enema
Time frame: After the children finish their enema, an average of 1 minute.
Number of defecation during bowel preparation
Time frame: After the children finish their bowel preparation, an average of 1 minute.
Medication compliance
Time frame: After the children finish their bowel preparation, an average of 3 minutes.
Adverse reactions of bowel preparation
Time frame: During children's bowel preparation, an average of 24 hours.
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 22 Oct 2024.
- Results publication: PubMed 15758907Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
- Results publication: PubMed 17269992Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. doi: 10.1111/j.1365-2036.2006.03212.x.
- Results publication: PubMed 17111052Barkun A, Chiba N, Enns R, Marcon M, Natsheh S, Pham C, Sadowski D, Vanner S. Commonly used preparations for colonoscopy: efficacy, tolerability, and safety--a Canadian Association of Gastroenterology position paper. Can J Gastroenterol. 2006 Nov;20(11):699-710. doi: 10.1155/2006/915368.
- Results publication: PubMed 29112090Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.
- Results publication: PubMed 34238885Wu R, Ji WY, Yang C, Zhan Q. A Systematic Review and Meta-Analysis of Low-Residue Diet Versus Clear Liquid Diet: Which Is Better for Bowel Preparation Before Colonoscopy? Gastroenterol Nurs. 2021 Sep-Oct 01;44(5):341-352. doi: 10.1097/SGA.0000000000000554.
- Individual participant dataSharing planned: No. we will not make individual participant data available to other reseasrchers
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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.
Ying Gu, 3 study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid diet group, Enteral nutrition group and Low residual diet group in people with Bowel Preparation, run by Children's Hospital of Fudan University 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 2 inclusion and 4 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 22 Oct 2024. 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?
Boston Bowel Preparation Scale score (time frame: After the children finish their bowel preparation, an average of 5 minutes). 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 NCT05609591, which also lists 5 linked publications.
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 22 Oct 2024.