Phase
Condition
Constipation
Treatment
botox injection
biofeed back sessions
lubiprostone , single arm
Clinical Study ID
Ages 4-16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Children and adolescents aged from 4 to 16 years.
Participants fulfilling Rome IV criteria for the diagnosis of functionalconstipation. 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 symptomscannot be fully explained by another medical condition (Hyams et al., 2016).
- Participants who have chronic refractory constipation. Chronic refractoryconstipation (CRC) is defined as children who are unable to pass stools in spite ofbeing on maximum laxative therapy and require daily rectal stimulation in the formof enemas or suppositories to pass stools 4-Is willing and able to keep a diary onhis/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
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 Design
Study Description
Connect with a study center
Ain shams university
Cairo,
EgyptActive - Recruiting
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