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Protein Isolate

serum bovine immunoglobulin (SBI) medical food for Chronic Obstructive Pulmonary Disease (SBI for COPD Trial)

N/A
Waitlist Available
Led By Luca Paoletti, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: serum bovine immunoglobulin (SBI) medicalfoodExperimental Treatment1 Intervention
SBI medical food 10 gr powder substance by mouth twice a day for 6 months
Group II: serum bovine immunoglobulin (SBI) medical foodExperimental Treatment1 Intervention
SBI medical food 5 gr powder substance by mouth twice a day for 6 months
Group III: inactive powder substancePlacebo Group1 Intervention
inactive powder substance by mouth twice a day for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Serum bovine immunoglobulin (SBI) medical food
2013
N/A
~20

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
967 Previous Clinical Trials
7,399,684 Total Patients Enrolled
Entera Health, IncIndustry Sponsor
11 Previous Clinical Trials
570 Total Patients Enrolled
Luca Paoletti, MDPrincipal InvestigatorMedical University of South Carolina
~1 spots leftby Oct 2025
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