Anorectal Manometery in Pediatric Chronic Refractory Constipation

Phase 1

Recruiting

• Conditions: Chronic Constipation
• Interventions: Drug: lubiprostone , single arm; Procedure: biofeed back sessions; Procedure: botox injection

• Registration Number: NCT06543979
• Lead Sponsor: Ain Shams University

Brief 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

Detailed Description

Primary objective: To assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence.

Secondary objective: To determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. To assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. To assess the effect of elimination of cow milk products in patient with chronic refractory constipation.

Study Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Study Start: 2024-09-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-09-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm as all participant will receive the treatment	biofeed back sessions	all participant will receive lubiprostone
single arm as all participant will receive the treatment	botox injection	all participant will receive lubiprostone
single arm as all participant will receive the treatment	lubiprostone , single arm	all participant will receive lubiprostone

Primary Outcome Measures

Name	Time	Method
To evaluate the manometric parameters in children with chronic refractory constipation	1 year	To measure the percent of the most common manometric parameters in children with chronic refractory constipation e.g dyssengeric defecation and reduced rectal sensetivity and anal sphincter dysfunction.
evaluate the efficacy of oral administration of lubiprostone 8 and 24 μg once daily for 4 weeks in participants with chronic refractory constipation	1 month	Spontaneous Bowel Movement (SBM) Frequency at Week 1,2,3 and 4 A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.

Secondary Outcome Measures

Name	Time	Method
To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity	3 months	Participants with chronic refractory constipation and manometry parameters showed dyssengeric defecation or hyposensitivity will receive biofeedback sessions and the investigators measure the difference in bowel management scoring tool before and after the biofeedback sessions the higher the score the worest the condition
To determine the effect of cow milk protein free diet on chronic refractory constipation in children	1 month	Participants will receive cow milk free diet for 4 weeks and investigators measure the difference in bowel management scoring tool before and after cow milk free diet the higher the score the worest the condition
To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure	3 month	Participants with chronic refractory and manometric parameters showed high anal canal resting pressure will have botulinum toxin injection and investigators measure the difference in bowel management scoring tool before and after the injection the higher the score the worest the condition

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt