Anorectal Manometery in Pediatric Chronic Refractory Constipation

NCT06543979 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: manometery in constipation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity

  3 months

• To determine the effect of cow milk protein free diet on chronic refractory constipation in children

  1 month

• To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure

  3 month

Study Arms (1)

single arm as all participant will receive the treatment

OTHER

all participant will receive lubiprostone

Drug: lubiprostone , single arm; Procedure: biofeed back sessions; Procedure: botox injection

Interventions

lubiprostone , single arm DRUG

laxative

Also known as: lubicont

single arm as all participant will receive the treatment

biofeed back sessions PROCEDURE

Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations

single arm as all participant will receive the treatment

botox injection PROCEDURE

Botulinum toxin injection for participants suffering from elevated anal canal pressure

single arm as all participant will receive the treatment

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged from 4 to 16 years.
• 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:
• 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).
• 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.
• 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.

You may not qualify if:

• participants who have anorectal malformation
• participants who have neurological disease affecting lower limbs
• Has a history of hypersensitivity or allergies to lubiprostone

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Lubiprostone; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• asmaa abdelnaby mohamed soliman, master

  assistant lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

asmaa abdelnaby mohamed soliman, master

CONTACT

+2001070689789; samka2015.abdelnaby@gmail.com

yosra mohamed mohsen awad, MD

CONTACT

01001831590

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of pediatrics

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: August 9, 2024
• Study Start: September 7, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

EG (1)