Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency

Completed

• Conditions: Intestinal Insufficiency; Short Bowel Syndrome
• Interventions: Drug: Drug prescription pattern

• Registration Number: NCT01696656
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-28
• Last Update Submitted: 2012-09-28
• Study First Posted: 2012-10-01
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intestinal insufficiency	Drug prescription pattern	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.

Primary Outcome Measures

Name	Time	Method
Major gastrointestinal adjuvant prescription	Last 12 months	The most prescribed adjuvant agent for alleviation of gastrointestinal troubles such as diarrhea, malabsorption or gastric hypersecretion.

Secondary Outcome Measures

Name	Time	Method
Major antibiotic adjuvant prescription	Last 12 months	Principal antibiotic employed for suspected or actual bacterial overgrowth associated with diarrhea, malabsorption or systemic aberrations.

Trial Locations

Locations (1)

Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077; 🇧🇷 Sao Paulo, Brazil