Constipation, Neurologically ImpairedNCT07740785
This Study Aims to Evaluate the Safety and Efficacy of Fiber Supplementation on Constipation in Neurologically Impaired Children Using Rectal Wall Thickness Measurement by Ultrasound.
A study testing Psyllium Husk and Fiber in people with Constipation, Neurologically Impaired, run by Ain Shams University at 1 site in Egypt.
Trial summary
The current increasing survival of children with central nervous system damage has created a major challenge for medical care. Gastrointestinal and nutritional problems in neurologically impaired children have been recognized as an integral part of their disease, often leading to growth failure and worsened quality of… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Constipation, Neurologically Impaired
- What is being tested?
- Psyllium Husk and Fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2025to 1 Nov 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged from 2 years to 14 years
- Patients with upper motor neuronal lesion confirmed by MRI , who are following at Neurology clinic for at least 6 months before enrollment.
- Those suffering from constipation according to Rome IV criteria as the presence of the following two or more symptoms for at least 3 months, with symptom onset at least 6 months prior to diagnosis: having two or fewer defecations per week, history of excessive stool retention, history of painful or hard bowel movements, history of large-diameter stools that may obstruct the toilet, presence of a large fecal mass in the rectum and at least one episode per week of incontinence after the acquisition of toileting skills.
Who cannot join
- Patients with constipation and have any comorbidities contributing to constipation ex: hypothyroidism, diabetes mellitus, cow milk protein allergy (CMPA) and anorectal deformities.
- Patient following any certain regimen due to inborn errors of metabolism and those who underwent any gastrointestinal tract (GIT) surgeries as resection anastomosis.
- Patients on ketogenic diet as line of managing epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Dietary Fiber Intervention on Constipation in Neurologically Impaired Children.
The current increasing survival of children with central nervous system damage has created a major challenge for medical care. Gastrointestinal and nutritional problems in neurologically impaired children have been recognized as an integral part of their disease, often leading to growth failure and worsened quality of life for both children and caregivers. (1) Measuring rectal wall thickness to highlight the benefit of dietary intervention to constipated children having neurological impairment will be a novel point in this study.
- Conditions
- Constipation, Neurologically Impaired
- Being tested
- Psyllium Husk, Fiber
- Keywords
- constipation, neurologically impaired, fiber
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium HuskDietary supplement
Psyllium husk 5gm per day
FiberDietary supplement
this group will be advised regarding increasing daily fiber intake
| Study group | Role | What they receive |
|---|---|---|
| Intervention group neurologically impaired children with constipation | Experimental | They will receive psyllium husk Receives: Dietary Supplement: Psyllium Husk; Dietary Supplement: Fiber |
| Control group, Neurologically impaired children with constipation | Active comparator | will receive awarness about increasing dietary fiber intake Receives: Dietary Supplement: Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups will be used as a objective method of assessing constipation in those patients
Measured: 3 to 6 months
To decrease the incidence of constipation in children with neurological impairment as well as improve bowel function.
Aim of the primary outcome is to decrease the incidence of constipation in children with neurological impairment and improve bowel function by using same methods referred to in study design and methodology
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start10 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation, Neurologically ImpairedStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740785
- Sponsor's protocol ID
- MS 804/2025
- Status last verified
- Nov 2025
- First submitted
- 18 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Fiber Intervention on Constipation in Neurologically Impaired Children.
- ClinicalTrials.gov ID
- NCT07740785
- Acronym / sponsor ID
- MS 804/2025
- Conditions
- Constipation, Neurologically Impaired
- Keywords
- constipation, neurologically impaired, fiber
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Aug 2026 (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 current increasing survival of children with central nervous system damage has created a major challenge for medical care. Gastrointestinal and nutritional problems in neurologically impaired children have been recognized as an integral part of their disease, often leading to growth failure and worsened quality of life for both children and caregivers. (1) Measuring rectal wall thickness to highlight the benefit of dietary intervention to constipated children having neurological impairment will be a novel point in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group neurologically impaired children with constipation | Experimental | Dietary Supplement: Psyllium Husk, Dietary Supplement: FiberThey will receive psyllium husk |
| Control group, Neurologically impaired children with constipation | Active comparator | Dietary Supplement: Fiberwill receive awarness about increasing dietary fiber intake |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged from 2 years to 14 years
- Patients with upper motor neuronal lesion confirmed by MRI , who are following at Neurology clinic for at least 6 months before enrollment.
- Those suffering from constipation according to Rome IV criteria as the presence of the following two or more symptoms for at least 3 months, with symptom onset at least 6 months prior to diagnosis: having two or fewer defecations per week, history of excessive stool retention, history of painful or hard bowel movements, history of large-diameter stools that may obstruct the toilet, presence of a large fecal mass in the rectum and at least one episode per week of incontinence after the acquisition of toileting skills.
Key exclusion criteria (3 listed)
- Patients with constipation and have any comorbidities contributing to constipation ex: hypothyroidism, diabetes mellitus, cow milk protein allergy (CMPA) and anorectal deformities.
- Patient following any certain regimen due to inborn errors of metabolism and those who underwent any gastrointestinal tract (GIT) surgeries as resection anastomosis.
- Patients on ketogenic diet as line of managing epilepsy.
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 |
|---|---|---|
| Psyllium HuskPsyllium husk 5gm per day | Dietary supplement | Intervention group neurologically impaired children with constipation |
| Fiberthis group will be advised regarding increasing daily fiber intake | Dietary supplement | Control group, Neurologically impaired children with constipation, Intervention group neurologically impaired children with constipation |
Primary outcome
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups
Time frame: 3 to 6 months
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups will be used as a objective method of assessing constipation in those patients
To decrease the incidence of constipation in children with neurological impairment as well as improve bowel function.
Time frame: 3 to 6 months
Aim of the primary outcome is to decrease the incidence of constipation in children with neurological impairment and improve bowel function by using same methods referred to in study design and methodology
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 3 Aug 2026.
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 Psyllium Husk and Fiber in people with Constipation, Neurologically Impaired, run by Ain Shams University 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 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 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 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?
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?
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?
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups (time frame: 3 to 6 months). 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 3 Aug 2026.