Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Inflammatory Bowel Diseases
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Single-center, randomized control double blinded prospective clinical trialMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Once the consent is signed, each participant will be assigned a unique study number, which will replace any identifiable data for the remainder of the study. The code key will be stored in a divisional research University of Texas, Houston-secure website. The participants will then be randomized to receive either SBI or placebo (in form of hydrolyzed collagen) to be taken once daily for a total of 60 days. The medical products will be supplied to the participants in a blinded manner by the principal investigator and study co-ordinator.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 30 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04223518
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Monisha Shah, M.D. The University of Texas Health Science Center, Houston Study Director: Jon Marc Rhoads, M.D. The University of Texas Health Science Center, Houston
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