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Immunoglobulin
Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)
Phase < 1
Waitlist Available
Led By Monisha Shah, M.D.
Research Sponsored by Monisha Hitesh Shah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 15, 60 and 90
Summary
This trial will test the safety and effectiveness of a protein powder made from cow serum, to see if it can help improve symptoms in children and young adults with inflammatory bowel disease.
Eligible Conditions
- Inflammatory Bowel Disease
- Colitis
- Perianal Fistulas
- Crohn's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 0, 15, 60 and 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 15, 60 and 90
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease
Secondary study objectives
Effect of SBI on disease activity (CRP)
Effect of SBI on disease activity (ESR)
Effect of SBI on disease activity (calprotectin)
+10 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Serum Bovine ImmunoglobulinActive Control1 Intervention
Study product: Serum bovine immunoglobulin, also known by the trade name of Enteragam Dosage form: powdered packet Dosage: Each packet (10 g net weight) consists of 5 g of serum-derived bovine immunoglobulin/protein isolate (SBI) which is the active ingredient Frequency: one packet a day Duration: 60 days
Group II: Hydrolyzed CollagenPlacebo Group1 Intervention
Placebo: hydrolyzed collagen Dosage form: powdered packet Dosage: 10 g of hydrolyzed collagen per packet Frequency: one packet a day Duration: 60 days
Find a Location
Who is running the clinical trial?
Monisha Hitesh ShahLead Sponsor
Monisha Shah, M.D.Principal InvestigatorThe University of Texas Health Science Center, Houston
Jon Marc Rhoads, M.D.Study DirectorThe University of Texas Health Science Center, Houston