Assessing Anorectal Function in Children with Chronic Constipation
The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence
This study is testing different treatments for children aged 4 to 16 with chronic constipation to see what helps improve their symptoms and understand why they have these issues.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 16 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06543979 on ClinicalTrials.gov |
What this trial studies
This study evaluates the patterns of anorectal manometry in children aged 4 to 16 years suffering from chronic refractory constipation, with or without fecal incontinence. It aims to understand the underlying causes of their symptoms, such as sphincter dysfunction or pelvic floor issues, through high-resolution anorectal manometry. Additionally, the study will explore the effectiveness of various treatments, including lubiprostone, biofeedback sessions, and botox injections, while also assessing dietary changes like the elimination of cow milk products. The study will monitor safety and tolerability throughout the interventions.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 4 to 16 years who meet the Rome IV criteria for functional constipation and have chronic refractory constipation.
Not a fit: Patients whose constipation is fully explained by other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide targeted treatment options for children suffering from chronic constipation, improving their quality of life.
How similar studies have performed: Other studies have shown promising results using anorectal manometry to guide treatment in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children and adolescents aged from 4 to 16 years. 2. Participants fulfilling Rome IV criteria for the diagnosis of functional constipation. At least 2 of the following present at least once per week for at least 1 month: * 2 or fewer defecations in the toilet per week * At least 1 episode of fecal incontinence per week * History of retentive posturing or excessive volitional stool retention * History of painful or hard bowel movements * Presence of a large fecal mass in the rectum * History of large-diameter stools that may obstruct the toilet The symptoms cannot be fully explained by another medical condition (Hyams et al., 2016). 3. Participants who have chronic refractory constipation. Chronic refractory constipation (CRC) is defined as children who are unable to pass stools in spite of being on maximum laxative therapy and require daily rectal stimulation in the form of enemas or suppositories to pass stools 4-Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire. 5-The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: * participants who have anorectal malformation * participants who have neurological disease affecting lower limbs * Has a history of hypersensitivity or allergies to lubiprostone
Where this trial is running
Cairo
- Ain shams university — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: asmaa abdelnaby mohamed soliman, master — assistant lecturer
- Study coordinator: asmaa abdelnaby mohamed soliman, master
- Email: samka2015.abdelnaby@gmail.com
- Phone: +2001070689789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.