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

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696656
• Other study ID #: Gutadjuvant1
• Secondary ID: 0540/11
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: September 28, 2012
• Start date: September 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Intestinal Insufficiency
• Short Bowel Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Main vitamin/mineral adjuvant prescription	Vitamin, mineral or other micronutrient required for correction of nutrition deficiency, not available or poorly absorbed via current parenteral/enteral nutrition regimen	Last 12 months	No
Primary	Major gastrointestinal adjuvant prescription	The most prescribed adjuvant agent for alleviation of gastrointestinal troubles such as diarrhea, malabsorption or gastric hypersecretion.	Last 12 months	No
Secondary	Major antibiotic adjuvant prescription	Principal antibiotic employed for suspected or actual bacterial overgrowth associated with diarrhea, malabsorption or systemic aberrations.	Last 12 months	No