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Active Not Recruiting
NCT07740785
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.
Conditions: Constipation, Neurologically Impaired
Sex: All
Ages: 2 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Ain Shams University
Location: Ain Shams University Cairo Cairo Governorate
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07740785). StuddyBuddy aggregates publicly available trial information.