Skip to content

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.

The Impact of Dietary Fiber Intervention on Constipation in Neurologically Impaired Children.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07740785
Enrollment
60
Registered
2026-08-03
Start date
2025-11-10
Completion date
2026-11-01
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Neurologically Impaired

Keywords

constipation, neurologically impaired, fiber

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTPsyllium Husk

Psyllium husk 5gm per day

DIETARY_SUPPLEMENTFiber

this group will be advised regarding increasing daily fiber intake

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anterior rectal wall thickness measured by ultrasonography in each group before and after intervention and comparing both groups3 to 6 monthsAnterior 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.3 to 6 monthsAim 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026