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Sponsors and Collaborators: |
University of Arkansas American Society of Health-System Pharmacists Research and Education Foundation |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00577499 |
Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency, and achieving and maintaining adequate nutrition is an important goal of therapy because it is positively correlated with lung function. Lubiprostone activates chloride channels in the GI tract. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. This project is an observational study to examine the effects of lubiprostone on nutritional status and lung function in adults with CF. Our hypothesis is that lubiprostone will have beneficial effects on nutritional status.
Condition |
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Cystic Fibrosis Constipation Nutrition |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis |
Estimated Enrollment: | 15 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | May 2009 |
Groups/Cohorts |
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Only group
adult cystic fibrosis patients who are not at goal body mass index and have started lubiprostone therapy within one month of study enrollment
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Background: Cystic fibrosis (CF) affects an estimated 30,000 people in the United States. It is caused by a mutation in the gene encoding a protein called cystic fibrosis transmembrane regulator (CFTR). This protein functions as a chloride channel in epithelial cells of multiple organ systems. The mutation results in a dysfunctional or absent CFTR channel and a decrease in chloride secretion, which results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. This patient population commonly suffers from nutritional deficiency, and achieving and maintaining normal nutritional status is an important goal of therapy as body mass index (BMI) is positively correlated with FEV1, a measure of pulmonary function. Lubiprostone activates type 2 chloride channels (ClC-2) on the apical membrane of GI epithelial cells. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. Objectives: The proposed pilot project is a prospective observational study to examine the effects of lubiprostone in adults with CF. The specific aims are to determine the effects of lubiprostone on: 1) nutritional markers and 2) pulmonary function in adults with CF. Methods: Adults with CF who are currently taking lubiprostone chronically will be sought for enrollment. Study subjects will be followed for approximately 3-months with serial assessment of indicators of nutrition and pulmonary function. Nutritional markers to be measured include body weight, albumin, prealbumin, and vitamins A, D, and E. Pulmonary function will be assessed by pulmonary function tests, a survey to monitor for symptoms of pulmonary exacerbation, and monitoring of the frequency of hospitalizations and IV antibiotic use. Expected Results: We expect to see a beneficial effect on nutritional markers, body weight, and BMI. We hope this translates into a concomitant improvement in pulmonary function.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
adult cystic fibrosis clinic
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Arkansas for Medical Sciences ( Catherine E. O'Brien ) |
Study ID Numbers: | 84063, 07-JI-166 |
Study First Received: | December 18, 2007 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00577499 |
Health Authority: | United States: Institutional Review Board |
cystic fibrosis constipation lubiprostone nutrition pulmonary function |
Signs and Symptoms Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Signs and Symptoms, Digestive Cystic Fibrosis |
Fibrosis Lung Diseases Constipation Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes |