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

NCT ID: NCT01696656

Last Updated: 2012-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intestinal Insufficiency Short Bowel Syndrome

Keywords

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Gastrointestinal drugs Antibiotics Vitamins Minerals Intestinal insufficiency Short Bowel syndrome Adjuvant therapy Antacids Gastrointestinal motility modifiers Micronutrients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 prescription pattern

Intervention Type DRUG

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

Interventions

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Drug prescription pattern

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

Intervention Type DRUG

Other Intervention Names

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Gastrointestinal drugs Antibiotics Vitamins Minerals General drugs

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Joel Faintuch

Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruna Z Godoy, RPh

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 19047836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22244264 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22105729 (View on PubMed)

Other Identifiers

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0540/11

Identifier Type: OTHER

Identifier Source: secondary_id

Gutadjuvant1

Identifier Type: -

Identifier Source: org_study_id