Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT00577499 |
Recruitment Status :
Terminated
(Recruitment was suboptimal)
First Posted : December 20, 2007
Last Update Posted : March 4, 2015
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Condition or disease |
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Cystic Fibrosis Constipation Nutrition |
Study Type : | Observational |
Actual Enrollment : | 7 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Group/Cohort |
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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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- body mass index [ Time Frame: 3 months ]
- pulmonary function tests [ Time Frame: 3 months ]
- cystic fibrosis clinical score [ Time Frame: 3 months ]
- Serum nutritional markers (vitamins A, D, E; albumin; prealbumin) [ Time Frame: 3 months ]
- 24-hour diet recall [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Planning or currently on chronic lubiprostone therapy (chronic is defined as at least one 24 microgram capsule by mouth every other day
- Body mass index (BMI) of less than 22 for females and less than 23 for males at the initiation of chronic lubiprostone therapy
- Initiation of chronic lubiprostone therapy within 1 month of enrollment
- Age over 18
- Currently taking a multivitamin
Exclusion Criteria:
- History of noncompliance with medications and other CF therapies
- History of hospital admissions for CF exacerbations of ≥2 in the last 6 months
- FEV1 les than 40% of expected (severe dysfunction) at most recent assessment in the ambulatory setting
- Currently registered on a lung transplant waiting list
- Any other condition, in the opinion of the investigators, that interferes with the ability of the study subject to comply with study requirements, confers significant risk, or limits the ability of the subject to complete the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577499
Principal Investigator: | Catherine O'Brien, PharmD | University of Arkansas |
Responsible Party: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00577499 |
Other Study ID Numbers: |
84063 07-JI-166 |
First Posted: | December 20, 2007 Key Record Dates |
Last Update Posted: | March 4, 2015 |
Last Verified: | March 2015 |
cystic fibrosis constipation lubiprostone nutrition pulmonary function |
Cystic Fibrosis Fibrosis Constipation Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Signs and Symptoms, Digestive |