Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
serum bovine immunoglobulin
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSerum 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_SUPPLEMENTPlacebo
Hydrolyzed Collagen
Sponsors
Monisha Hitesh Shah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Single-center, randomized control double blinded prospective clinical trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients, ages 6-30 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 for children and Harvey Bradshaw Index/SCCAI for young adults
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease | Days 0, 15, 60 and 90 | Assessed by a change in albumin by at least 5% (primary end point) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of SBI on Body Mass Index (BMI) | Days 0, 15, 60 and 90 | Assessed quantitative valuation of Body Mass Index (BMI) in kg/m2 |
| Effects of SBI on nutritional marker: Vitamin D | Days 0 and 60 | Assessed quantitative valuation of 25-hydroxy vitamin D level in ng/mL |
| Effects of SBI on nutritional marker: pre-albumin | Days 0 and 60 | Assessed quantitative valuation of pre-albumin level in mg/dL |
| Effects of SBI on nutritional markers: transferrin and iron saturation | Days 0 and 60 | Assessed quantitative valuation of iron panel |
| Safety assessment for kidney function | Days 0, 15, 60 and 90 | Assessed quantitative valuation of kidney function as assessed by measurement of creatinine and Blood urea nitrogen (BUN) levels in mg/dL |
| Safety assessment for liver function | Days 0, 15, 60 and 90 | Assessed quantitative valuation of liver function as assessed by measurement of alanine transaminase (ALT) and aspartate aminotransferase (AST) in IU/L |
| Effects of SBI on weight | Days 0, 15, 60 and 90 | Assessed quantitative valuation of weight in kilograms |
| Effect of SBI on symptom of diarrhea for Crohn's disease | Days 0, 15, 60 and 90 | 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. |
| Effect of SBI on disease activity (ESR) | Days 0 and 60 | Assessed quantitative valuation of serum inflammatory marker: ESR measured in mm/hr |
| Effect of SBI on disease activity (CRP) | Days 0, 15, 60 and 90 | Assessed quantitative valuation of serum inflammatory marker: CRP measured in mg/L |
| Effect of SBI on disease activity (calprotectin) | Days 0 and 60 | Assessed quantitative valuation of fecal inflammatory marker: calprotectin measured in ug/g |
| Effect of SBI on stool microbiota | Days 0 and 60 | Assessed quantitative valuation of stool microbial community profiling by denaturing high pressure liquid chromatography (DHPLC) using broad range 16S rDNA PCR sequencing and bioinformatics |
| Effect of SBI on symptom of diarrhea for ulcerative colitis | Days 0, 15, 60 and 90 | 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. |
Countries
United States
Outcome results
None listed