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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 2012

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.

Interventions

  • Drug: Drug prescription pattern
    • Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records

Arms, Groups and Cohorts

  • Intestinal insufficiency
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

Home nutritional support longer than 12 months,full records and return visits available at the hospital system. - 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). -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joel Faintuch, Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School – University of Sao Paulo
  • Overall Official(s)
    • Bruna Z Godoy, RPh, Principal Investigator, University of Sao Paulo

References

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.

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.

Efsen E, Jeppesen PB. Modern treatment of adult short bowel syndrome patients. Minerva Gastroenterol Dietol. 2011 Dec;57(4):405-17.

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