RecruitingPhase 1/2

Anorectal Manometery in Pediatric Chronic Refractory Constipation

Egypt60 participantsStarted 2024-09-07

Plain-language summary

Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia

Who can participate

Age range4 Years – 16 Years

SexALL

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Inclusion criteria

✓. Children and adolescents aged from 4 to 16 years.
✓. Participants fulfilling Rome IV criteria for the diagnosis of functional constipation.
✓. 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.

What they're measuring

To evaluate the manometric parameters in children with chronic refractory constipation

Timeframe: 1 year

evaluate the efficacy of oral administration of lubiprostone 8 and 24 μg once daily for 4 weeks in participants with chronic refractory constipation

Timeframe: 1 month

Trial details

NCT IDNCT06543979

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

asmaa abdelnaby mohamed soliman, master

+2001070689789 samka2015.abdelnaby@gmail.com

View on ClinicalTrials.gov More Chronic Constipation trials