A Phase 1/2 interventional study of lubiprostone , single arm and biofeed back sessions in Chronic Constipation, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Ain Shams University · Phase 1/2, Interventional, and Treatment
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
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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:
all participant will receive lubiprostone
Drug: lubiprostone , single arm · Procedure: biofeed back sessions · Procedure: botox injection
laxative
Also known as: lubicont
Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations
Botulinum toxin injection for participants suffering from elevated anal canal pressure
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 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.
Time frame: 1 month
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 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
Time frame: 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
Time frame: 3 month
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Ain Shams University