NCT04223518

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

Terminated EARLY_PHASE1 Last updated 12 June 2025

What this trial tests

EARLY_PHASE1 trial testing Serum bovine immunoglobulin in Inflammatory Bowel Diseases in 6 participants. Terminated before completion.

Timeline

20 September 2020

Primary endpoint
31 May 2025

31 May 2025

Quick facts

Lead sponsor	Monisha Hitesh Shah
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	6
Start date	20 September 2020
Primary completion	31 May 2025
Estimated completion	31 May 2025
Sites	1 location across United States

Drugs / interventions tested

• Serum bovine immunoglobulin
• Placebo

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →
• Crohn Disease — all drugs for Crohn Disease →

Sponsor

Monisha Hitesh Shah

Who can join

Adults 6 to 30, any sex, with Inflammatory Bowel Diseases or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.