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OpenTrials
Completed

NCT Number: NCT01696656

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.

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Key information

Conditions

Intestinal Insufficiency Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077

São Paulo, 05403900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Drug prescription pattern

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Other outcomes

  1. Main vitamin/mineral adjuvant prescription

    Time frame: Last 12 months

    Vitamin, mineral or other micronutrient required for correction of nutrition deficiency, not available or poorly absorbed via current parenteral/enteral nutrition regimen

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 1, 2012
Registry last updated
Oct 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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