Child ObesityNCT04525560
Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
A study testing PEG-ELS-S and PEG-ELS-L in people with Child Obesity and Bowel Preparation, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children. Read more about this study
- Who is it for?
- Ages 2 to 22 years
- Conditions the study is for
- Child Obesity, Bowel Preparation
- What is being tested?
- PEG-ELS-S and PEG-ELS-L
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 30 May 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 2 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed children in Department of Gastroenterology at Children's Hospital of Fudan University
- According to the indications of electronic colonoscopy, colonoscopy was performed for the first time
- Age: 2-22 years old
Who cannot join
- Having contraindications of electronic colonoscopy
- Having contraindications of general anesthesia
- Previous abdominal surgery
- Chronic constipation
- There is evidence of intestinal stenosis and gastrointestinal malformation
- Laxatives or drugs in the intestinal preparation protocol of this study have been used before bowel preparation
- Disagree the use of the bowel preparation protocol developed in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
About this study
Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.
Read the detailed description
The adequacy of bowel preparation before colonoscopy is particularly important for the visualization of intestinal mucosa under colonoscopy. Some studies have shown that bowel preparation must be customized according to the age, weight and clinical status of the child. However, there is no internationally recognized standard scheme for pediatric intestinal reserve. In pediatric clinical trials, polyethylene glycol with electrolyte solution (PEG-ELS) is more effective than bisacodyl, folium sennae and magnesium citrate. PEG-ELS is an electrolyte balanced isotonic solution, which can be used to clean the intestinal tract by large volume irrigation. Polyethylene glycol 4000 is a long-chain linear polymer, which can hardly absorb and decompose after oral administration. It can effectively increase the composition of intestinal fluid, stimulate intestinal peristalsis, cause watery diarrhea, and achieve the purpose of cleaning the intestine. The inorganic salt composition and proper amount of water in the formula ensure the balance of water and electrolyte exchange between intestinal tract and body fluid. In this study, PEG-ELS short protocol and long protocol were selected for intestinal preparation, and the effectiveness and safety of different intestinal preparation protocols under electronic colonoscopy for children over 2 years old were compared.
- Conditions
- Child Obesity, Bowel Preparation
- Being tested
- PEG-ELS-S, PEG-ELS-L
- Keywords
- Child, Electronic colonoscopy, bowel preparation, polyethylene glycol with electrolyte solution
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-ELS-SOther
2/3 dose of PEG-ELS was taken orally from the evening on the day before colonoscopy, and the remaining 1/3 dose of PEG-ELS was orally administered in the morning of the next day.
PEG-ELS-LOther
PEG-ELS is given orally on the day before colonoscopy, which is divided into 10-12 portions and taken one portion every hour. If half of the total amount is not completed at afternoon ward round the day before colonoscopy, nasogastric feeding is recommended.
| Study group | Role | What they receive |
|---|---|---|
| PEG-ELS-S | Experimental | The dosage of PEG-ELS is given according to body weight: 10-15 kg, PEG-ELS 0.75 L; 15-22.5 kg, PEG-ELS 1.5 L; 22.5-30 kg, PEG-ELS 2.25 L; more than 30 kg, PEG-ELS 3 L. Receives: Other: PEG-ELS-S |
| PEG-ELS-L | Active comparator | The dosage of PEG-ELS is given according to body weight: 10-15 kg, PEG-ELS 0.75 L; 15-22.5 kg, PEG-ELS 1.5 L; 22.5-30 kg, PEG-ELS 2.25 L; more than 30 kg, PEG-ELS 3 L. Receives: Other: PEG-ELS-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleansing
Bowel cleansing was assessed by Boston bowel preparation scale (BBPS). The scores of left, middle and right colon were added up to the total score of BBPS, with the lowest score of 0 and the highest score of 9. The score of 8-9 represents excellent bowel preparation, 6-7 represents good, 4-5 represents average, and 0-3 represents poor. Excellent and good for intestinal preparation are qualified, general and poor for intestinal preparation are unqualified.
Measured: During the operation of electronic colonoscopy (about 15 min )
Secondary outcomes (6)
Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)
This variable is a binary variables (good/poor). Poor compliance was defined as PEG-ELS dosage less than 75% of the prescribed dose. Good compliance was defined as PEG-ELS dosage more than 75% of the prescribed dose. Prescribed dose and actually oral dose were recorded by nurse.
Measured: During bowel preparation (about 24 hours)
Adverse reactions receiving polyethylene glycol with electrolyte solution
This variable is a binary variables (Yes/No). The variable would be set to "Yes" as any adverse reactions including Nausea, vomiting, abdominal distension, abdominal pain or allergic to PEG-ELS appeared during bowel preparation.
Measured: During bowel preparation (about 24 hours)
Rate of nasal feeding PEG-ELS
Rate of nasal feeding PEG-ELS. Nasogastric feeding is recommended for those who cannot complete the prescribed amount.
Measured: During bowel preparation (about 24 hours)
Enema rate before colonoscopy
At 8 am on the day of electronic colonoscopy, no food and water were given from 8 am. At 11 am on the day of colonoscopy, the last assessment of stool was conducted. If the Bristol stool form scale (BSFS) ≤ 5 points, colonoscopy should be cancelled and bowel preparation time should be prolonged; if BFSF = 6 points, Warm normal saline (50 ml/kg) was given for enema; if BFSF = 7 points, no enema.
Measured: immediately before colonoscopy
Times of washing under colonoscopy
If the visual field is not clear, it should be washed during the operation of electronic colonoscopy.
Measured: During the operation of electronic colonoscopy (about 15 mins)
Adverse events
It is a repeated measured variable. This variable is a binary variables (Yes/No). The variable would be set to "Yes" as any adverse reactions. An adverse event refers to the event that occurs after a patient in a clinical study accepts a research-based product, which does not necessarily have a causal relationship with the test product. Adverse events are diseases, signs or symptoms (including abnormal laboratory results) that occur or worsen during the course of the study.
Measured: up to 30 minutes after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Aug 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525560
- Sponsor's protocol ID
- BP/2+
- Status last verified
- Oct 2021
- First submitted
- 21 Aug 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
- ClinicalTrials.gov ID
- NCT04525560
- Acronym / sponsor ID
- BP/2+
- Conditions
- Child Obesity, Bowel Preparation
- Keywords
- Child, Electronic colonoscopy, bowel preparation, polyethylene glycol with electrolyte solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 25 Aug 2020 (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.
Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.
Detailed description
The adequacy of bowel preparation before colonoscopy is particularly important for the visualization of intestinal mucosa under colonoscopy. Some studies have shown that bowel preparation must be customized according to the age, weight and clinical status of the child. However, there is no internationally recognized standard scheme for pediatric intestinal reserve. In pediatric clinical trials, polyethylene glycol with electrolyte solution (PEG-ELS) is more effective than bisacodyl, folium sennae and magnesium citrate. PEG-ELS is an electrolyte balanced isotonic solution, which can be used to clean the intestinal tract by large volume irrigation. Polyethylene glycol 4000 is a long-chain linear polymer, which can hardly absorb and decompose after oral administration. It can effectively increase the composition of intestinal fluid, stimulate intestinal peristalsis, cause watery diarrhea, and achieve the purpose of cleaning the intestine. The inorganic salt composition and proper amount of water in the formula ensure the balance of water and electrolyte exchange between intestinal tract and body fluid. In this study, PEG-ELS short protocol and long protocol were selected for intestinal preparation, and the effectiveness and safety of different intestinal preparation protocols under electronic colonoscopy for children over 2 years old were compared.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-ELS-S | Experimental | Other: PEG-ELS-SThe dosage of PEG-ELS is given according to body weight: 10-15 kg, PEG-ELS 0.75 L; 15-22.5 kg, PEG-ELS 1.5 L; 22.5-30 kg, PEG-ELS 2.25 L; more than 30 kg, PEG-ELS 3 L. |
| PEG-ELS-L | Active comparator | Other: PEG-ELS-LThe dosage of PEG-ELS is given according to body weight: 10-15 kg, PEG-ELS 0.75 L; 15-22.5 kg, PEG-ELS 1.5 L; 22.5-30 kg, PEG-ELS 2.25 L; more than 30 kg, PEG-ELS 3 L. |
Who may qualify
- Ages
- 2 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Newly diagnosed children in Department of Gastroenterology at Children's Hospital of Fudan University
- According to the indications of electronic colonoscopy, colonoscopy was performed for the first time
- Age: 2-22 years old
Key exclusion criteria (7 listed)
- Having contraindications of electronic colonoscopy
- Having contraindications of general anesthesia
- Previous abdominal surgery
- Chronic constipation
- There is evidence of intestinal stenosis and gastrointestinal malformation
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 |
|---|---|---|
| PEG-ELS-S2/3 dose of PEG-ELS was taken orally from the evening on the day before colonoscopy, and the remaining 1/3 dose of PEG-ELS was orally administered in the morning of the next day. | Other | PEG-ELS-S |
| PEG-ELS-LPEG-ELS is given orally on the day before colonoscopy, which is divided into 10-12 portions and taken one portion every hour. If half of the total amount is not completed at afternoon ward round the day before colonoscopy, nasogastric feeding is recommended. | Other | PEG-ELS-L |
Primary outcome
Bowel cleansing
Time frame: During the operation of electronic colonoscopy (about 15 min )
Bowel cleansing was assessed by Boston bowel preparation scale (BBPS). The scores of left, middle and right colon were added up to the total score of BBPS, with the lowest score of 0 and the highest score of 9. The score of 8-9 represents excellent bowel preparation, 6-7 represents good, 4-5 represents average, and 0-3 represents poor. Excellent and good for intestinal preparation are qualified, general and poor for intestinal preparation are unqualified.
6 secondary outcomes
Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)
Time frame: During bowel preparation (about 24 hours)
Adverse reactions receiving polyethylene glycol with electrolyte solution
Time frame: During bowel preparation (about 24 hours)
Rate of nasal feeding PEG-ELS
Time frame: During bowel preparation (about 24 hours)
Enema rate before colonoscopy
Time frame: immediately before colonoscopy
Times of washing under colonoscopy
Time frame: During the operation of electronic colonoscopy (about 15 mins)
Adverse events
Time frame: up to 30 minutes after colonoscopy
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 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-ELS-S and PEG-ELS-L in people with Child Obesity and 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 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 Oct 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?
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?
Bowel cleansing (time frame: During the operation of electronic colonoscopy (about 15 min )). 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 Oct 2021.