This is a randomized, double-blind placebo controlled study to assess for safety, tolerability and nutritional impact of oral serum bovine immunoglobulin (SBI) on pediatric patients and young adults with inflammatory bowel disease (IBD) as assessed by an increase in serum albumin and other nutritional markers including vitamin D level, pre-albumin, transferrin and iron saturation; and improvement in weight and body mass index. SBI is an animal derived protein isolate from the serum of cows containing \>50% IgG. It has been used for patients suffering from irritable bowel syndrome, human immunodeficiency virus enteropathy and antibiotic-associated diarrhea for symptomatic relief of diarrhea with good results and minimal side effects. However its role in IBD has not yet been investigated. The investigators hypothesize that the study product will have a positive nutritional impact along with symptom improvement for pediatric and young adult patients with IBD. The volunteers for our study will have established Crohn's disease or ulcerative colitis and will be treated with a daily powder (SBI or placebo) added to their breakfast food (egg, yogurt, or peanut butter are best) for total of 60 days followed by 30 day monitoring period after completion of treatment. The volunteers will be followed by clinic visits and labs on day 0, day 15, day 60 and day 90. There is the potential for the treatment to alter disease activity, a secondary outcome, as assessed by measurement of serum markers of inflammation (ESR, CRP), fecal calprotectin (validated marker of intestinal inflammation), and clinical indices like short pediatric Crohn's disease activity index (shPDCAI) or pediatric ulcerative colitis activity index (PUCAI) for children and Harvey Bradshaw Index or SCCAI for adults. Stool samples will be collected on day 0 and day 60 for 16S RNA sequencing to assess for changes in microbiota of the participants while on the study product/placebo. We plan to enroll 43 patients in the study to allow for data analysis of atleast 30 patients. The study will take place over 1 year and will be conducted at University of Texas-Children's Memorial Hermann Hospital, where we follow \> 125 children with inflammatory bowel disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
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.
Hydrolyzed Collagen
University of Texas Health Science Center at Houston
Houston, Texas, United States
Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease
Assessed by a change in albumin by at least 5% (primary end point)
Time frame: Days 0, 15, 60 and 90
Effects of SBI on nutritional marker: Vitamin D
Assessed quantitative valuation of 25-hydroxy vitamin D level in ng/mL
Time frame: Days 0 and 60
Effects of SBI on nutritional marker: pre-albumin
Assessed quantitative valuation of pre-albumin level in mg/dL
Time frame: Days 0 and 60
Effects of SBI on nutritional markers: transferrin and iron saturation
Assessed quantitative valuation of iron panel
Time frame: Days 0 and 60
Effects of SBI on weight
Assessed quantitative valuation of weight in kilograms
Time frame: Days 0, 15, 60 and 90
Effects of SBI on Body Mass Index (BMI)
Assessed quantitative valuation of Body Mass Index (BMI) in kg/m2
Time frame: Days 0, 15, 60 and 90
Safety assessment for kidney function
Assessed quantitative valuation of kidney function as assessed by measurement of creatinine and Blood urea nitrogen (BUN) levels in mg/dL
Time frame: Days 0, 15, 60 and 90
Safety assessment for liver function
Assessed quantitative valuation of liver function as assessed by measurement of alanine transaminase (ALT) and aspartate aminotransferase (AST) in IU/L
Time frame: Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for ulcerative colitis
Assessed quantitative valuation of clinical activity index: Pediatric Ulcerative Colitis Activity Index (PUCAI) score for children with ulcerative colitis and Simple Clinical Colitis Activity Index (SCCAI) for young adults with ulcerative colitis . Minimum and maximum values are 0 and 85 respectively for PUCAI and 0 and 19 for SCCAI, with higher scores relating to worse outcome.
Time frame: Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for Crohn's disease
Assessed quantitative valuation of clinical activity index: Short Pediatric Crohn's Disease Activity Index (shPCDAI) for children with Crohn's disease and Harvey Bradshaw Index(HBI) for young adults with Crohn's disease. Minimum and maximum values are 0 and 90 respectively for shPDCAI and 0 and \>16 for HBI, with higher scores relating to worse outcome.
Time frame: Days 0, 15, 60 and 90
Effect of SBI on disease activity (ESR)
Assessed quantitative valuation of serum inflammatory marker: ESR measured in mm/hr
Time frame: Days 0 and 60
Effect of SBI on disease activity (CRP)
Assessed quantitative valuation of serum inflammatory marker: CRP measured in mg/L
Time frame: Days 0, 15, 60 and 90
Effect of SBI on disease activity (calprotectin)
Assessed quantitative valuation of fecal inflammatory marker: calprotectin measured in ug/g
Time frame: Days 0 and 60
Effect of SBI on stool microbiota
Assessed quantitative valuation of stool microbial community profiling by denaturing high pressure liquid chromatography (DHPLC) using broad range 16S rDNA PCR sequencing and bioinformatics
Time frame: Days 0 and 60
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