Clinical trial NCT01696656: Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency
Official title: Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Insufficiency
Short Bowel Syndrome
Keywords: Gastrointestinal drugs
Antibiotics
Vitamins
Minerals
Intestinal insufficiency
Short Bowel syndrome
Adjuvant therapy
Antacids
Gastrointestinal motility modifiers
Micronutrients
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with short bowel syndrome secondary to trauma, Crohn´s disease, mesenteric thrombosis, radiation enteritis and other conditions, suffering from intestinal insufficiency and undergoing home-parenteral or enteral nutrition.

Brief summary: Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Prescriptional pattern of these drugs will be analyzed in a clinical cohort.

Detailed description: Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Little attention has been given to the indications and dosage schedules of such drugs, many of which are employed as off-label prescriptions because of lack of official guidelines.

Prescriptional patterns of these drugs will be analyzed in a clinical cohort of home parenteral/enteral nutrition patients, registered at the outpatient service of Hospital das Clinicas, Sao Paulo, Brazil.

Eligibility criteria: Inclusion Criteria: Home nutritional support longer than 12 months,full records and return visits available at the hospital system.

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Exclusion Criteria: Critical illness, death, discontinuation of nutritional therapy, registered for intestinal transplantation, additional gastrointestinal operations for short bowel syndrome (valves, lengthening) or for other conditions (gallbladder disease, intestinal obstruction, necrosis, infection).

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Primary outcomes:
measure: Major gastrointestinal adjuvant prescription
timeFrame: Last 12 months
Secondary outcomes:
measure: Major antibiotic adjuvant prescription
timeFrame: Last 12 months
Other outcomes:
measure: Main vitamin/mineral adjuvant prescription
timeFrame: Last 12 months
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077
Study officials:
affiliation: University of Sao Paulo
name: Bruna Z Godoy, RPh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tilg H. Short bowel syndrome: searching for the proper diet. Eur J Gastroenterol Hepatol. 2008 Nov;20(11):1061-3. doi: 10.1097/MEG.0b013e3283040cc9.
citation: Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current management of short bowel syndrome. Curr Probl Surg. 2012 Feb;49(2):52-115. doi: 10.1067/j.cpsurg.2011.10.002. No abstract available.
citation: Efsen E, Jeppesen PB. Modern treatment of adult short bowel syndrome patients. Minerva Gastroenterol Dietol. 2011 Dec;57(4):405-17.