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New treatment option for Chronic Constipation
Official title Anorectal Manometery in Pediatric Chronic Refractory Constipation
ClinicalTrials.gov ID: NCT06543979
What this study is testing
What is lubiprostone , single arm?
lubiprostone , single arm is an investigational medicine, being studied as a potential treatment for chronic constipation.
Also referred to as lubicont.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 16
You may be able to join 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...
- 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
You likely can't join if
- participants who have anorectal malformation
- participants who have neurological disease affecting lower limbs
- Has a history of hypersensitivity or allergies to lubiprostone
See the full eligibility criteria
- 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:
- 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).
- 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...
- participants who have anorectal malformation
- participants who have neurological disease affecting lower limbs
- Has a history of hypersensitivity or allergies to lubiprostone
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.