Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Years - 18 Years|
Inclusion Criteria:- Pediatric patients, ages 6-18 years diagnosed with inflammatory bowel disease (UC/Crohn's disease) based on the pediatric ulcerative colitis activity index/ short pediatric Crohn's disease activity index
Exclusion Criteria:- Patients with severe illness requiring inpatient admission - Patients with known allergy to beef or beef products, sunflower lecithin and dextrose - Patients with liver function tests elevated to more than 3 times the upper limit of normal - Pregnancy or breastfeeding
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Monisha Hitesh Shah|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Monisha Shah, M.D.Jon Marc Rhoads, M.D.|
|Principal Investigator Affiliation||The University of Texas Health Science Center, HoustonThe University of Texas Health Science Center, Houston|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Inflammatory Bowel Diseases, Celiac Disease, Ulcerative Colitis|
|Study Website:||View Trial Website|
Active Comparator: Serum Bovine Immunoglobulin
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
Placebo Comparator: Hydrolyzed Collagen
Placebo: hydrolyzed collagen Dosage form: powdered packet Dosage: 10 g of hydrolyzed collagen per packet Frequency: one packet a day Duration: 60 days
Dietary Supplement: - Serum bovine immunoglobulin
Serum bovine immunoglobulin (SBI), also known by the brand name of Enteragam (Proliant Biologicals, Ankeny, Iowa) is derived from bovine serum and classified as a medical food composed of >90% protein which consists primarily of immunoglobulins (>50% of IgG) along with other bovine proteins and peptides similar to those commonly consumed by humans in beef products.
Dietary Supplement: - Placebo
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Monisha Shah, M.D.
For additional contact information, you can also visit the trial on clinicaltrials.gov.