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Can a daily fiber supplement ease constipation in kids with brain injuries?

NCT ID NCT07740785

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether a daily psyllium husk supplement or increased dietary fiber can relieve constipation in children aged 2 to 14 with neurological impairment. Participants will be divided into two groups: one receiving psyllium husk, the other receiving advice on increasing fiber intake. The study uses ultrasound to measure rectal wall thickness as an objective way to assess constipation before and after the intervention, aiming to improve bowel function and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Psyllium husk (a dietary fiber supplement) and dietary fiber advice
What this could lead to
If it works, this could point toward a simple, safe dietary approach to ease constipation and improve quality of life for children with neurological impairment.
What could go wrong
This is a small, early-stage trial, and results may not apply to all children. Fiber can sometimes cause bloating or gas, and the benefit may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ain Shams University

    Cairo, Cairo Governorate, 11252, Egypt