Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)

Monisha Hitesh Shah

Status and phase: Terminated; Early Phase 1

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Serum bovine immunoglobulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04223518

HSC-MS-19-0998

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups, including a placebo group

Serum Bovine Immunoglobulin

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Serum bovine immunoglobulin

Hydrolyzed Collagen

Placebo Comparator group

Description:

Placebo: hydrolyzed collagen Dosage form: powdered packet Dosage: 10 g of hydrolyzed collagen per packet Frequency: one packet a day Duration: 60 days

Treatment:

Dietary Supplement: Placebo