Physical Therapy in Pediatric Functional ConstipationNCT06207721
Physical Therapy for Functional Constipation in Children
A study testing Polyethylene Glycols and Physical therapy program in people with Physical Therapy in Pediatric Functional Constipation, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Physical Therapy in Pediatric Functional Constipation
- What is being tested?
- Polyethylene Glycols and Physical therapy program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Dec 2023
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children diagnosed as functional constipation.
- aged from 4 to 18 years old
- from both sex
Who cannot join
- children diagnosed as constipation caused by medicine Bowel surgery, Endocrine and metabolic disorders , Neurological and psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment
- Being tested
- Polyethylene Glycols, Physical therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene GlycolsDrug
Polyethylene Glycols syrup (0.7 g/kg daily)
Physical therapy programOther
The physical therapy program includes exercises and massage
| Study group | Role | What they receive |
|---|---|---|
| Control group (A) | Experimental | conventional treatment by diet regimen and laxatives Receives: Drug: Polyethylene Glycols |
| study Group (B) | Experimental | physical therapy program in addition to conventional treatment by diet regimen and laxatives Receives: Drug: Polyethylene Glycols; Other: Physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rome-III criteria
assessment for functional constipation symptoms
Measured: after 6 months of interventions
Secondary outcomes (1)
short form 36 questionnaire
assessment for quality of life
Measured: after 6 months of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Oct 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Therapy in Pediatric Functional ConstipationStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207721
- Sponsor's protocol ID
- constipation in children
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soliman A, AboAli SEM, Abdel Karim AE, Elsamahy SA, Hasan J, Hassan BA, Mohammed AH. Effect of adding telerehabilitation home program to pharmaceutical treatment on the symptoms and the quality of life in children with functional constipation: a randomized controlled trial. Eur J Pediatr. 2024 Sep;183(9):3943-3958. doi: 10.1007/s00431-024-05639-8. Epub 2024 Jun 26.
PubMed 38922435
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy for Functional Constipation in Children
- ClinicalTrials.gov ID
- NCT06207721
- Acronym / sponsor ID
- constipation in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 Jan 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.
Children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (A) | Experimental | Drug: Polyethylene Glycolsconventional treatment by diet regimen and laxatives |
| study Group (B) | Experimental | Drug: Polyethylene Glycols, Other: Physical therapy programphysical therapy program in addition to conventional treatment by diet regimen and laxatives |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children diagnosed as functional constipation.
- aged from 4 to 18 years old
- from both sex
Key exclusion criteria (1 listed)
- children diagnosed as constipation caused by medicine Bowel surgery, Endocrine and metabolic disorders , Neurological and psychiatric disorders.
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 |
|---|---|---|
| Polyethylene GlycolsPolyethylene Glycols syrup (0.7 g/kg daily) | Drug | Control group (A), study Group (B) |
| Physical therapy programThe physical therapy program includes exercises and massage | Other | study Group (B) |
Primary outcome
Rome-III criteria
Time frame: after 6 months of interventions
assessment for functional constipation symptoms
1 secondary outcome
short form 36 questionnaire
Time frame: after 6 months of interventions
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 29 Mar 2024.
- Derived from this study: PubMed 38922435Soliman A, AboAli SEM, Abdel Karim AE, Elsamahy SA, Hasan J, Hassan BA, Mohammed AH. Effect of adding telerehabilitation home program to pharmaceutical treatment on the symptoms and the quality of life in children with functional constipation: a randomized controlled trial. Eur J Pediatr. 2024 Sep;183(9):3943-3958. doi: 10.1007/s00431-024-05639-8. Epub 2024 Jun 26.
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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 Polyethylene Glycols and Physical therapy program in people with Physical Therapy in Pediatric Functional Constipation, run by Delta University for Science and Technology at 1 site in Egypt.
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 1 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 29 Mar 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 Egypt. 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?
Rome-III criteria (time frame: after 6 months of interventions). 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 NCT06207721, which also lists 1 linked publication.
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 29 Mar 2024.