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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joel Faintuch, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01696656
First received: September 27, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Intestinal Insufficiency
Short Bowel Syndrome
Drug: Drug prescription pattern

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Major gastrointestinal adjuvant prescription [ Time Frame: Last 12 months ] [ Designated as safety issue: No ]
    The most prescribed adjuvant agent for alleviation of gastrointestinal troubles such as diarrhea, malabsorption or gastric hypersecretion.


Secondary Outcome Measures:
  • Major antibiotic adjuvant prescription [ Time Frame: Last 12 months ] [ Designated as safety issue: No ]
    Principal antibiotic employed for suspected or actual bacterial overgrowth associated with diarrhea, malabsorption or systemic aberrations.


Other Outcome Measures:
  • Main vitamin/mineral adjuvant prescription [ Time Frame: Last 12 months ] [ Designated as safety issue: No ]
    Vitamin, mineral or other micronutrient required for correction of nutrition deficiency, not available or poorly absorbed via current parenteral/enteral nutrition regimen


Enrollment: 37
Study Start Date: September 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Gastrointestinal drugs
  • Antibiotics
  • Vitamins
  • Minerals
  • General drugs

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696656

Locations
Brazil
Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077
Sao Paulo, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Bruna Z Godoy, RPh University of Sao Paulo
  More Information

Additional Information:
Publications:
Responsible Party: Joel Faintuch, Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01696656     History of Changes
Other Study ID Numbers: Gutadjuvant1, 0540/11
Study First Received: September 27, 2012
Last Updated: September 28, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Gastrointestinal drugs
Antibiotics
Vitamins
Minerals
Intestinal insufficiency
Short Bowel syndrome
Adjuvant therapy
Antacids
Gastrointestinal motility modifiers
Micronutrients

Additional relevant MeSH terms:
Short Bowel Syndrome
Syndrome
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Pathologic Processes
Postoperative Complications
Gastrointestinal Agents
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014