Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency
|ClinicalTrials.gov Identifier: NCT01696656|
Recruitment Status : Completed
First Posted : October 1, 2012
Last Update Posted : October 1, 2012
|Condition or disease||Intervention/treatment|
|Intestinal Insufficiency Short Bowel Syndrome||Drug: Drug prescription pattern|
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.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Patients with variable categories of major intestinal resection due to benign diseases,suffering from intestinal insufficiency and maintained with home nutritional support. Only clinically stable and nonhospitalized subjects will be recruited.
Drug: Drug prescription pattern
Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records
- Major gastrointestinal adjuvant prescription [ Time Frame: Last 12 months ]The most prescribed adjuvant agent for alleviation of gastrointestinal troubles such as diarrhea, malabsorption or gastric hypersecretion.
- Major antibiotic adjuvant prescription [ Time Frame: Last 12 months ]Principal antibiotic employed for suspected or actual bacterial overgrowth associated with diarrhea, malabsorption or systemic aberrations.
- Main vitamin/mineral adjuvant prescription [ Time Frame: Last 12 months ]Vitamin, mineral or other micronutrient required for correction of nutrition deficiency, not available or poorly absorbed via current parenteral/enteral nutrition regimen
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696656
|Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077|
|Sao Paulo, Brazil, 05403900|
|Principal Investigator:||Bruna Z Godoy, RPh||University of Sao Paulo|