Anorectal Manometery in Pediatric Chronic Refractory Constipation
ConditionChronic Constipation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-16
SponsorAin Shams University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents aged from 4 to 16 years.
Participants fulfilling Rome IV criteria for the diagnosis of functional constipation.
2 or fewer defecations in the toilet per week
At least 1 episode of fecal incontinence per week
Disqualifiers
participants who have anorectal malformation
participants who have neurological disease affecting lower limbs
Has a history of hypersensitivity or allergies to lubiprostone
Trial design
Design model
Single group
Treatments tested in this trial
lubiprostone , single arm
Druglaxative
biofeed back sessions
Procedure/SurgeryBiofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations
botox injection
Procedure/SurgeryBotulinum toxin injection for participants suffering from elevated anal canal pressure
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: single arm as all participant will receive the treatmentOther 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year2
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.
Time frame
1 monthSecondary outcomes
1
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
Time frame
3 months2
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
Time frame
1 month3
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
Time frame
3 monthSponsors and contacts
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Source ClinicalTrials.gov