Functional ConstipationNCT06357897
The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
A study testing Local PEG4000 and Commercial PEG4000 in people with Functional Constipation, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Local PEG4000 and Commercial PEG4000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- 3 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children will be enrolled in this study when they meet 2 criteria:
- Age from 6 months to 18 years old
- Children are diagnosed with FC according to ROME IV criteria
Who cannot join
- Children will be excluded from the study if they meet any of the following criteria:
- Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, hypothyroidism, etc.
- Suspected GI obstruction
- Receiving medication affecting bowel movement
- Having a history of allergy to PEG and stevia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
About this study
Official title: Faculty of Medicine, Chulalongkorn University
This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.
Read the detailed description
Total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. They will be randomised in Group A or Group B.
Children in group A will receive PEG-Chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
Children in group B will receive the standard PEG formula (Forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
PEG-Chula and standard PEG will be prepared in sachets with similar packaging and appearance labelled A, B, C, D.
Children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner.
Parents will be advised to record symptoms, dietary intake, and dose of medication in a logbook.
Children will visit the researchers on days 7, 14, 28, and 56 to collect data on symptoms, stool diameter, bowel size measured by ultrasound, side effects, and medication compliance. Children with poor compliance will be excluded from the study.
- Conditions
- Functional Constipation
- Being tested
- Local PEG4000, Commercial PEG4000
- Keywords
- Functional constipation, Children, Polyethylene glycol, Palatability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local PEG4000Drug
Also called PEG-Chula
PEG-Chula is developed from PEG 4000 used at King Chulalongkorn Memorial Hospital with added sweetener and flavours. Children will be given PEG-Chula at a dose of 0.5 - 1 g/kg/day.
Commercial PEG4000Drug
Also called Forlax
For commercial PEG, We use Forlax as the control group. Children will be given Forlax at a dose of 0.5 - 1 g/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| PEG-Chula | Experimental | PEG-Chula is developed from local PEG 4000 used at King Chulalongkorn Memorial Hospital (KCMH) with the addition of sweetener and flavours and prepared into sachets labelled A, B, C and D. Receives: Drug: Local PEG4000 |
| Standard PEG | Other | Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance. Receives: Drug: Commercial PEG4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of stool
The frequency of stool per day
Measured: At 7 days, 14 days, 28 days and 56 days
Stool consistency assessed by Bristol stool chart
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool
Measured: At 7 days, 14 days, 28 days and 56 days
Secondary outcomes (6)
Fecal incontinence
Number of fecal incontinence occurs per day
Measured: At 7 days, 14 days, 28 days and 56 days
Rectal diameter measured by transabdominal ultrasonography
Rectal diameter in centimeters is measured by transabdominal ultrasonography.
Measured: At 7 days, 14 days, 28 days, 56 days and 2 years
Anterior wall thickness measured by transabdominal ultrasonography
Anterior wall thickness in centimeters is measured by transabdominal ultrasonography.
Measured: At 7 days, 14 days, 28 days, 56 days and 2 years
Adverse events
Adverse events (i.e diarrhea, abdominal pain, bloating, nausea or vomiting)
Measured: At 7 days, 14 days, 28 days and 56 days
Palatability of medication assessed by facial Hedonic scale
The facial Hedonic scale contains 5 pictures of facial expression and number 1 mean dislike very much while number 5 means like very much
Measured: At 7 days, 14 days, 28 days and 56 days
Change of gut microbiota before and after treatment
Stools is collected before treatment at baseline and at the end of treatment. Gut microbiota was analyzed by Nanopore technique.
Measured: At baseline and 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start3 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group received PEG-Chula Control group received Forlax
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duc Long Tran, Chulalongkorn University
- Investigators
- Palittiya Sintusek, Ph.D., Study chair, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357897
- Sponsor's protocol ID
- 0093/67
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data were collected anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faculty of Medicine, Chulalongkorn University
- ClinicalTrials.gov ID
- NCT06357897
- Acronym / sponsor ID
- 0093/67
- Conditions
- Functional Constipation
- Keywords
- Functional constipation, Children, Polyethylene glycol, Palatability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 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.
This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.
Detailed description
Total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. They will be randomised in Group A or Group B.
Children in group A will receive PEG-Chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
Children in group B will receive the standard PEG formula (Forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
PEG-Chula and standard PEG will be prepared in sachets with similar packaging and appearance labelled A, B, C, D.
Children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner.
Parents will be advised to record symptoms, dietary intake, and dose of medication in a logbook.
Children will visit the researchers on days 7, 14, 28, and 56 to collect data on symptoms, stool diameter, bowel size measured by ultrasound, side effects, and medication compliance. Children with poor compliance will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Intervention group received PEG-Chula Control group received Forlax
| Arm | Type | Receives |
|---|---|---|
| PEG-Chula | Experimental | Drug: Local PEG4000PEG-Chula is developed from local PEG 4000 used at King Chulalongkorn Memorial Hospital (KCMH) with the addition of sweetener and flavours and prepared into sachets labelled A, B, C and D. |
| Standard PEG | Other | Drug: Commercial PEG4000Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age from 6 months to 18 years old
- Children are diagnosed with FC according to ROME IV criteria
Key exclusion criteria (5 listed)
- Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, hypothyroidism, etc.
- Suspected GI obstruction
- Receiving medication affecting bowel movement
- Having a history of allergy to PEG and stevia.
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 |
|---|---|---|
| Local PEG4000Also: PEG-ChulaPEG-Chula is developed from PEG 4000 used at King Chulalongkorn Memorial Hospital with added sweetener and flavours. Children will be given PEG-Chula at a dose of 0.5 - 1 g/kg/day. | Drug | PEG-Chula |
| Commercial PEG4000Also: ForlaxFor commercial PEG, We use Forlax as the control group. Children will be given Forlax at a dose of 0.5 - 1 g/kg/day. | Drug | Standard PEG |
Primary outcome
The frequency of stool
Time frame: At 7 days, 14 days, 28 days and 56 days
The frequency of stool per day
Stool consistency assessed by Bristol stool chart
Time frame: At 7 days, 14 days, 28 days and 56 days
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool
6 secondary outcomes
Fecal incontinence
Time frame: At 7 days, 14 days, 28 days and 56 days
Rectal diameter measured by transabdominal ultrasonography
Time frame: At 7 days, 14 days, 28 days, 56 days and 2 years
Anterior wall thickness measured by transabdominal ultrasonography
Time frame: At 7 days, 14 days, 28 days, 56 days and 2 years
Adverse events
Time frame: At 7 days, 14 days, 28 days and 56 days
Palatability of medication assessed by facial Hedonic scale
Time frame: At 7 days, 14 days, 28 days and 56 days
Change of gut microbiota before and after treatment
Time frame: At baseline and 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. The data were collected anonymous.
Related trials for Functional Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
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.
Palittiya Sintusek, Ph.D. study chair
Chulalongkorn 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 Local PEG4000 and Commercial PEG4000 in people with Functional Constipation, run by Chulalongkorn University at 1 site in Thailand.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duc Long Tran, M.D. (+66916668748, tdlong@ctump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of stool (time frame: At 7 days, 14 days, 28 days and 56 days). 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?
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 2 Apr 2026.