Polyethylene GlycolsNCT05424757
Polyethylene Glycol Safety in Children
An observational study of Polyethylene Glycols and Children, Only, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The primary objective is to measure levels of selected PEG 3350 components and metabolites in the blood and urine of children who are already taking PEG 3350 compared to children who are not taking PEG 3350. Changes to medical therapy are not recommended as part of this study. Read more about this study
- Who is it for?
- Ages 0 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyethylene Glycols, Children, Only
- What is being tested?
- PEG 3350
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 9 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 0 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study population will be selected from children cared for at The Children's Hospital of Philadelphia.
Who may be able to join
- Children less than 17 years old who have been taking PEG 3350 for at least one month.
- Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day currently recommended by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines (2). Preferences will be given to children taking at least 17 grams/day.
- Normal Physical and neurological development for age. Weight and height percentiles ≥ 5% and ≤ 95% for age.
- Children less than 17 years old who have been taking PEG 3350 for at least one month.
- Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day currently recommended by the NASPGHAN and ESPGHAN guidelines (2). Preferences will be given to children taking at 17 grams/day.
- Any of the following problems associated with increased bowel permeability:
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- Weight ≤ 5% for age. Malnutrition is associated with increased intestinal permeability.
- Children who had a pathogen (see Group 1 Exclusion Criteria "A. b." for list of pathogens) isolated from their stool within the past month.
- Children with celiac disease who are untreated or began treatment within the past 3 months.
- Children with inflammatory bowel disease
- Children with Hirschsprung disease. This intestinal motility disorder predisposes to bowel injury called enterocolitis (18-20).
- Children with intestinal motility disorders other than Hirschsprung disease.
- Children less than 17 years old who have been taking PEG 3350 for at least one month.
- Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day currently recommended by the NASPGHAN and ESPGHAN guidelines (2). Preference will be given to children taking at least 17 grams/day.
- Any of the following problems with the nervous system:
- Diagnosed with a disease that affects nervous system function before starting PEG 3350.
- Diagnosed with a disease that affects nervous system function after starting PEG 3350.
- Abnormal nervous system function without a specific diagnosis.
- Episodic nervous system dysfunction. This might include seizure disorder, metabolic disease, or mitochondrial disease.
- Note: Included in Group 3 are children with cerebral palsy, neuronal migration defects, traumatic brain injury, hypoxic ischemic encephalopathy, seizure disorder, tics, migraine, clinical depression, anxiety disorder, obsessive-compulsive disorder, post-surgical brain injury, autism spectrum disorder as well as genetic defects that affect the nervous system (Cornelia de Lange, Rett Syndrome, Pelizaeus-Merzbacher disease, etc.).
- Any weight and height (i.e., no exclusions based on growth percentiles). Abnormalities in any organ including the bowel are acceptable.
Who cannot join
- Children with underlying bowel problems that might be expected to increase bowel permeability (are included in group 2). In this group we will specifically exclude children with:
- Diarrhea within the past month. Note that PEG 3350 may cause loose stool and this is often the intended therapeutic effect. Therefore, we will exclude children with presumed infectious diarrhea since this may alter gut permeability but will include children whose loose stool is attributed to PEG 3350. If loose or watery stool began after initiation of PEG 3350 or after an increase in PEG 3350 dose within prior 3 days, children may be enrolled for GROUP 1.
- Children whose stool had a recognized diarrhea causing pathogen within the past 4 months will be excluded since the time required to repair epithelial lining is not clear. Enteric pathogens that would prevent enrollment include Salmonella, Shigella, Campylobacter, Yersinia, E. Coli (enterotoxigenic, enteropathogenic, enteraggregative, enterohemorrhagic), Clostridum difficile, Rotavirus, Norovirus, Astrovirus, and other known or suspected diarrhea causing organisms.
- pylori infection since this causes a stomach inflammation. HIV infection since this may alter bowel permeability (17) and predispose to other types of infection Symptoms neurologic disease or dysfunction (since they will be enrolled in Group 3).
- Group 2: Children with problems that might increase intestinal epithelial permeability.
- Children with neurologic or neuropsychiatric symptoms. These children will be enrolled in Group 3.
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- Group 3: Children with underlying neurologic disease or with neuropsychiatric disorders or symptoms.
- There are no specific exclusion criteria. This is important since this group may be at the highest risk for PEG 3350 side effects.
- Group 4: Children who are not taking PEG 3350. We will enroll 75 children who are not taking PEG 3350. Inclusion and exclusion criteria for these children will be the same as those detailed above for children who are taking PEG 3350 except that they may not have taken PEG 3350 within the last month.
- Enrollment targets for Groups 1, 2 and 3:
- 15 children taking PEG 3350, age 0-6 years old (for each Group).
- 6 children taking PEG 3350, age 7-12 years old (for each Group).
- 4 children taking PEG 3350, age 13-17 years old (for each Group).
- An equal number of children in each age group who are not taking PEG 3350.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Quantitative Analysis of Selected PEG 3350 Components and Metabolites in Children's Plasma and Urine
The primary objective is to measure levels of selected PEG 3350 components and metabolites in the blood and urine of children who are already taking PEG 3350 compared to children who are not taking PEG 3350.
Changes to medical therapy are not recommended as part of this study.
Read the detailed description
For subjects taking PEG 3350, blood and urine will be collected 1.5 to 4 hours after subjects take PEG 3350.
For subjects who are not taking PEG 3350, the same PEG 3350 components and metabolites will be measured in blood and urine.
PEG 3350 containing medicines from study subjects will be analyzed for the same PEG 3350 components and metabolites.
A stool specimen will be collected for future studies.
Additional data will be obtained from:
- Review of medical records.
- A brief questionnaire.
- Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment (for children more than 1.5 years old)
- Bayley-IV Social-Emotional Scale assessment (for children less than 1.5 years old)
- Conditions
- Polyethylene Glycols, Children, Only
- Being tested
- PEG 3350
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350Drug
Data and biospecimens will be collected from two groups of children:
- Children who have taken PEG 3350 daily for at least 30 days.
- Children who have NOT taken PEG 3350 for at least 30 days.
No changes to medicines are recommended as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Children who are taking PEG 3350 | * Children less than 17 years old who have taken PEG 3350 daily for at least 30 days.
* Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day.
* Preference will be given to children taking at least 17 grams/day.
Notes:
Only children who are already taking PEG 3350 as part of their current medical regimen will be included. Changes to medical therapy are not recommended as part of this study.
Children in three subgroups will be enrolled:
1. Children with no known bowel or nervous system disease or neuropsychiatric symptoms.
2. Children with bowel problems that might increase intestinal permeability.
3. Children with neurologic disease or with neuropsychiatric disorders or symptoms. Receives: Drug: PEG 3350 | |
| Children who are not taking PEG 3350 | * Children less than 17 years old who have NOT taken PEG 3350 for at least 30 days. Children in three subgroups will be included: 1. Children with no known bowel or nervous system disease or neuropsychiatric symptoms. 2. Children with bowel problems that might increase intestinal permeability. 3. Children with neurologic disease or with neuropsychiatric disorders or symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEG 3350 related molecules in plasma
Plasma levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
Measured: 15 minutes
PEG 3350 related molecules in urine
Urine levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
Measured: 10 minutes
PEG 3350 related molecules in medicine samples
Medicine sample levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
Measured: 5 minutes
Neurobehavioral symptoms in children who are taking PEG 3350
Participants will complete a short symptom questionnaire specific to this study. The questionnaire asks if specific symptoms are present and if they changed after the child started PEG 3350 containing medicine.
Measured: 5 minutes
Baseline neurobehavioral symptoms in children who are not taking PEG 3350
Participants will complete a short symptom questionnaire specific to this study.
Measured: 5 minutes
Assessment of current Child behavior (1.5 years to 18 years old)
Families with children >1.5 years to 18 years old will complete an age-appropriate Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment. Specific CBCL forms are available for ages 1.5 to 5 years and for 6 to 18 years.
Standard scores are scaled. 50 is average for age and gender. Standard deviation is 10 points. Higher scores indicate greater problems. Normal = below 93%. Borderline = 93-97%. Clinical range = above 97%.
Measured: 30 minutes
Assessment of current Child behavior (< 1.5 years old)
Caregivers with children < 1.5 years old will complete a Bayley-4 Social-Emotional Scale (BSID-IV) assessment. The BSID-IV Social-Emotional Scale is an adaptation of the Greenspan Social-Emotional Growth Chart: A Screening Questionnaire for Infants and Young Children. The Social-Emotional Scale assesses acquisition of social and emotional milestones.
Items assess mastery of functional emotional skills, such as self-regulation and interest in the world; communicating needs; engaging others and establishing relationships; using emotions in a purposeful manner; and using emotional signals to solve problems.
The standardized mean motor score is 100 (SD 15), with scores lower than 85 indicating mild impairment, and lower than 70 indicating moderate or severe impairment.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start30 Sep 2022
- Primary completion9 Aug 2025
- Study completion9 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyethylene GlycolsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Robert O Heuckeroth, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424757
- Sponsor's protocol ID
- 14-011454
- Other IDs
- 1R01FD005312-01
- Status last verified
- Nov 2025
- First submitted
- 15 Jun 2022
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of Selected PEG 3350 Components and Metabolites in Children's Plasma and Urine
- ClinicalTrials.gov ID
- NCT05424757
- Acronym / sponsor ID
- 14-011454
- Conditions
- Polyethylene Glycols, Children, Only
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 9 Aug 2025 (actual)
- Study completion
- 9 Aug 2025 (actual)
- First posted
- 21 Jun 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.
The primary objective is to measure levels of selected PEG 3350 components and metabolites in the blood and urine of children who are already taking PEG 3350 compared to children who are not taking PEG 3350.
Changes to medical therapy are not recommended as part of this study.
Detailed description
For subjects taking PEG 3350, blood and urine will be collected 1.5 to 4 hours after subjects take PEG 3350.
For subjects who are not taking PEG 3350, the same PEG 3350 components and metabolites will be measured in blood and urine.
PEG 3350 containing medicines from study subjects will be analyzed for the same PEG 3350 components and metabolites.
A stool specimen will be collected for future studies.
Additional data will be obtained from:
- Review of medical records.
- A brief questionnaire.
- Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment (for children more than 1.5 years old)
- Bayley-IV Social-Emotional Scale assessment (for children less than 1.5 years old)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children who are taking PEG 3350 | – | Drug: PEG 3350* Children less than 17 years old who have taken PEG 3350 daily for at least 30 days. * Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day. * Preference will be given to children taking at least 17 grams/day. Notes: Only children who are already taking PEG 3350 as part of their current medical regimen will be included. Changes to medical therapy are not recommended as part of this study. Children in three subgroups will be enrolled: 1. Children with no known bowel or nervous system disease or neuropsychiatric symptoms. 2. Children with bowel problems that might increase intestinal permeability. 3. Children with neurologic disease or with neuropsychiatric disorders or symptoms. |
| Children who are not taking PEG 3350 | – | –* Children less than 17 years old who have NOT taken PEG 3350 for at least 30 days. Children in three subgroups will be included: 1. Children with no known bowel or nervous system disease or neuropsychiatric symptoms. 2. Children with bowel problems that might increase intestinal permeability. 3. Children with neurologic disease or with neuropsychiatric disorders or symptoms. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study population will be selected from children cared for at The Children's Hospital of Philadelphia.
Key inclusion criteria (21 listed)
- Children less than 17 years old who have been taking PEG 3350 for at least one month.
- Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day currently recommended by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines (2). Preferences will be given to children taking at least 17 grams/day.
- Normal Physical and neurological development for age. Weight and height percentiles ≥ 5% and ≤ 95% for age.
- Children less than 17 years old who have been taking PEG 3350 for at least one month.
- Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day currently recommended by the NASPGHAN and ESPGHAN guidelines (2). Preferences will be given to children taking at 17 grams/day.
Key exclusion criteria (14 listed)
- Children with underlying bowel problems that might be expected to increase bowel permeability (are included in group 2). In this group we will specifically exclude children with:
- Diarrhea within the past month. Note that PEG 3350 may cause loose stool and this is often the intended therapeutic effect. Therefore, we will exclude children with presumed infectious diarrhea since this may alter gut permeability but will include children whose loose stool is attributed to PEG 3350. If loose or watery stool began after initiation of PEG 3350 or after an increase in PEG 3350 dose within prior 3 days, children may be enrolled for GROUP 1.
- Children whose stool had a recognized diarrhea causing pathogen within the past 4 months will be excluded since the time required to repair epithelial lining is not clear. Enteric pathogens that would prevent enrollment include Salmonella, Shigella, Campylobacter, Yersinia, E. Coli (enterotoxigenic, enteropathogenic, enteraggregative, enterohemorrhagic), Clostridum difficile, Rotavirus, Norovirus, Astrovirus, and other known or suspected diarrhea causing organisms.
- pylori infection since this causes a stomach inflammation. HIV infection since this may alter bowel permeability (17) and predispose to other types of infection Symptoms neurologic disease or dysfunction (since they will be enrolled in Group 3).
- Group 2: Children with problems that might increase intestinal epithelial permeability.
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 3350Data and biospecimens will be collected from two groups of children: * Children who have taken PEG 3350 daily for at least 30 days. * Children who have NOT taken PEG 3350 for at least 30 days. No changes to medicines are recommended as part of this study. | Drug | Children who are taking PEG 3350 |
Primary outcome
PEG 3350 related molecules in plasma
Time frame: 15 minutes
Plasma levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
PEG 3350 related molecules in urine
Time frame: 10 minutes
Urine levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
PEG 3350 related molecules in medicine samples
Time frame: 5 minutes
Medicine sample levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
Neurobehavioral symptoms in children who are taking PEG 3350
Time frame: 5 minutes
Participants will complete a short symptom questionnaire specific to this study. The questionnaire asks if specific symptoms are present and if they changed after the child started PEG 3350 containing medicine.
Baseline neurobehavioral symptoms in children who are not taking PEG 3350
Time frame: 5 minutes
Participants will complete a short symptom questionnaire specific to this study.
Assessment of current Child behavior (1.5 years to 18 years old)
Time frame: 30 minutes
Families with children >1.5 years to 18 years old will complete an age-appropriate Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment. Specific CBCL forms are available for ages 1.5 to 5 years and for 6 to 18 years. Standard scores are scaled. 50 is average for age and gender. Standard deviation is 10 points. Higher scores indicate greater problems. Normal = below 93%. Borderline = 93-97%. Clinical range = above 97%.
Assessment of current Child behavior (< 1.5 years old)
Time frame: 90 minutes
Caregivers with children < 1.5 years old will complete a Bayley-4 Social-Emotional Scale (BSID-IV) assessment. The BSID-IV Social-Emotional Scale is an adaptation of the Greenspan Social-Emotional Growth Chart: A Screening Questionnaire for Infants and Young Children. The Social-Emotional Scale assesses acquisition of social and emotional milestones. Items assess mastery of functional emotional skills, such as self-regulation and interest in the world; communicating needs; engaging others and establishing relationships; using emotions in a purposeful manner; and using emotional signals to solve problems. The standardized mean motor score is 100 (SD 15), with scores lower than 85 indicating mild impairment, and lower than 70 indicating moderate or severe impairment.
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 4 Nov 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Robert O Heuckeroth, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyethylene Glycols and Children, Only, run by Children's Hospital of Philadelphia at 1 site in United States.
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 21 inclusion and 14 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 4 Nov 2025. 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 United States. 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?
PEG 3350 related molecules in plasma (time frame: 15 minutes). The study lists 7 primary outcomes in all. 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 4 Nov 2025.