Anorectal Manometery in Pediatric Chronic Refractory Constipation

The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Constipation
• Intervention / Treatment: Drug: lubiprostone , single arm; Procedure: biofeed back sessions; Procedure: botox injection

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: yosra mohamed mohsen awad, MD; Phone Number: 01001831590
• Study Contact Backup: Name: asmaa abdelnaby mohamed soliman, master; Phone Number: +2001070689789; Email: samka2015.abdelnaby@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • AIN shams university
    • Contact: Asmaa Abdelnaby, Master; Phone Number: 01070689789; Email: Samka2015.abdelnaby@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single arm as all participant will receive the treatment; all participant will receive lubiprostone	Drug: lubiprostone , single arm; laxative; Other Names: lubicont; Procedure: biofeed back sessions; Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations; Procedure: botox injection; Botulinum toxin injection for participants suffering from elevated anal canal pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the manometric parameters in children with chronic refractory constipation	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.	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	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity	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	3 months
To determine the effect of cow milk protein free diet on chronic refractory constipation in children	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	1 month
To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure	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	3 month

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: asmaa abdelnaby mohamed soliman, master, Assistant Lecturer

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: manometery in constipation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes