Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD

NCT ID: NCT02067377

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31

Brief Summary

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.

Conditions

Advanced COPD (GOLD Stage 3 or 4) With Cachexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

inactive powder substance

inactive powder substance by mouth twice a day for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo (for serum bovine immunoglobulin)

Intervention Type: DIETARY_SUPPLEMENT

serum bovine immunoglobulin (SBI) medical food

SBI medical food 5 gr powder substance by mouth twice a day for 6 months

Group Type: EXPERIMENTAL

Serum bovine immunoglobulin (SBI) medical food

Intervention Type: DIETARY_SUPPLEMENT

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.

serum bovine immunoglobulin (SBI) medicalfood

SBI medical food 10 gr powder substance by mouth twice a day for 6 months

Group Type: EXPERIMENTAL

Serum bovine immunoglobulin (SBI) medical food

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo (for serum bovine immunoglobulin)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Entera Health, Inc

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Paoletti, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

000027289

Identifier Type: -

Identifier Source: org_study_id