This study will evaluate the use of a medical food, oral serum-derived bovine immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a wasting syndrome) improve their nutritional status and gain weight. The medical food is in powder form and is mixed with a liquid such as water or orange juice and consumed by swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the nutritional status of cachexic patients with advanced stages of COPD.
Full Title of Study: “A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: April 2016
- Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food
- Serum bovine immunoglobulin (SBI) is an FDA regulated, orally administered prescription medical food intended for the nutritional management of patients who are unable to absorb necessary nutrients as a result of therapeutic or chronic medical problems.
- Dietary Supplement: Placebo (for serum bovine immunoglobulin)
Arms, Groups and Cohorts
- Placebo Comparator: inactive powder substance
- inactive powder substance by mouth twice a day for 6 months
- Experimental: serum bovine immunoglobulin (SBI) medical food
- SBI medical food 5 gr powder substance by mouth twice a day for 6 months
- Experimental: serum bovine immunoglobulin (SBI) medicalfood
- SBI medical food 10 gr powder substance by mouth twice a day for 6 months
Clinical Trial Outcome Measures
- The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months.
- Time Frame: 6 months
- The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months.
- Time Frame: 6 months
Participating in This Clinical Trial
- Age between age 30 and 80 at Baseline Visit
- Diagnosed with 2012 spirometric COPD GOLD Stage 3 (FEV1/FVC ratio <0.70, FEV1 30-49% of normal) or GOLD Stage 4 (FEV1/FVC <0.70, FEV1 <30% of normal or FEV1<50% of normal with chronic respiratory failure present)
- Able to tolerate and willing to undergo study procedures
- Body Mass Index below 21
- Signed Informed Consent
- History of comorbid condition severe enough to significantly impact 6 months outcomes
- Current substance abuse, including tobacco, alcohol and illicit drugs
- Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
- Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
- Active pulmonary infection with tuberculosis
- Non-COPD obstructive lung disease (various bronchiolitides, sarcoidosis, LAM, histiocytosis X) or parenchymal lung disease, pulmonary vascular disease, pleural disease, severe kyphoscoliosis, neuromuscular weakness, or other cardiovascular and pulmonary disease, that limit the interpretability of the pulmonary function measures
- Prior significant difficulties with pulmonary function testing
- Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers, or to beef
- History of lung or other organ transplant
- Currently taking >20mg of prednisone or equivalent systemic corticosteroid
- Currently taking any immunosuppressive agent
- History of lung cancer or any cancer that spread to multiple locations in the body
- Known HIV/AIDS infection
- History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
- Current or planned pregnancy within the study course.
- Currently institutionalized (e.g., prisons, long-term care facilities)
Gender Eligibility: All
Minimum Age: 30 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Medical University of South Carolina
- Entera Health, Inc
- Provider of Information About this Clinical Study
- Overall Official(s)
- Luca Paoletti, MD, Principal Investigator, Medical University of South Carolina
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