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

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 Overview

• Status: Completed
• Conditions: Short Bowel Syndrome; Intestinal Insufficiency
• Intervention / Treatment: Drug: Drug prescription pattern

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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403900
    • Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Drug prescription pattern; Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records; Other Names: Antibiotics; Gastrointestinal drugs; Vitamins; Minerals; General drugs

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Bruna Z Godoy, RPh, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 28, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Micronutrients; Antibiotics; Adjuvant therapy; Vitamins; Minerals; Gastrointestinal drugs; Antacids; Intestinal insufficiency; Short Bowel syndrome; Gastrointestinal motility modifiers
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Short Bowel Syndrome; Anti-Infective Agents; Anti-Bacterial Agents; Gastrointestinal Agents
• Other Study ID Numbers: Gutadjuvant1; 0540/11 (Other Identifier: USaoPaulo)