Phase
Condition
Ileus
Bowel Dysfunction
Treatment
Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
Clinical Study ID
Ages 3-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has short bowel syndrome, defined as 50% or less of expected bowel lengthbased on subject age and/or height, and measured at the time of the subject's priorintestinal resection.
Minimum residual bowel length of 3 cm.
Male or female patients aged 3 mo to 65 years inclusive
The subject, parent or legal guardian of the subject is able to read, understand,and is willing to provide informed consent.
The subject or parent or legal guardian of the patient is able to understand therequirements of the study and is willing to bring the subject to all clinic visitsand complete all study related procedures (as determined by the investigator).
Exclusion
Exclusion Criteria:
Ultra-short bowel syndrome defined as less than 3 cm of bowel length.
Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerativecolitis)
Evidence of active or prior Crohn's disease.
Primary intestinal failure (i.e., without loss or resection of intestinal tissue).
Coagulopathy, as defined by INR > 1.4 or platelets < 100.
Known immunocompromised status including, but not limited to, individuals who haveundergone organ transplantation, chemotherapy or radiotherapy within the past 12months, who have clinically significant leukopenia, who are positive for the humanimmunodeficiency virus (HIV) or whose immune status makes the subject a poorcandidate for clinical trial participation in the opinion of the Investigator.
Subject is determined by the investigator to be unsuitable for participation in thistrial for any reason.
Study Design
Study Description
Connect with a study center
University of California San Francisco
San Francisco, California 94143
United StatesSite Not Available
Stanford University School of Medicine
Stanford, California 94304
United StatesSite Not Available
Lucile Packard Children's Hospital Stanford
Palo Alto 5380748, California 5332921 94303
United StatesActive - Recruiting
University of California San Francisco
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Stanford University School of Medicine
Stanford 5398563, California 5332921 94304
United StatesActive - Recruiting
Children's National Hospital
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesActive - Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio 45229-3026
United StatesSite Not Available
Cincinnati Children's Hospital
Cincinnati 4508722, Ohio 5165418 45229-3026
United StatesActive - Recruiting

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