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

August 11, 2022 updated by: Monisha Hitesh Shah

Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Science Center at Houston
        • Contact:
        • Contact:
        • Sub-Investigator:
          • J. Marc Rhoads, M.D.
        • Principal Investigator:
          • Monisha Shah, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Enteragam
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: Placebo
Hydrolyzed Collagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease
Time Frame: Days 0, 15, 60 and 90
Assessed by a change in albumin by at least 5% (primary end point)
Days 0, 15, 60 and 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of SBI on nutritional marker: Vitamin D
Time Frame: Days 0 and 60
Assessed quantitative valuation of 25-hydroxy vitamin D level in ng/mL
Days 0 and 60
Effects of SBI on nutritional marker: pre-albumin
Time Frame: Days 0 and 60
Assessed quantitative valuation of pre-albumin level in mg/dL
Days 0 and 60
Effects of SBI on nutritional markers: transferrin and iron saturation
Time Frame: Days 0 and 60
Assessed quantitative valuation of iron panel
Days 0 and 60
Effects of SBI on weight
Time Frame: Days 0, 15, 60 and 90
Assessed quantitative valuation of weight in kilograms
Days 0, 15, 60 and 90
Effects of SBI on Body Mass Index (BMI)
Time Frame: Days 0, 15, 60 and 90
Assessed quantitative valuation of Body Mass Index (BMI) in kg/m2
Days 0, 15, 60 and 90
Safety assessment for kidney function
Time Frame: 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
Days 0, 15, 60 and 90
Safety assessment for liver function
Time Frame: 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
Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for ulcerative colitis
Time Frame: 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.
Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for Crohn's disease
Time Frame: 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.
Days 0, 15, 60 and 90
Effect of SBI on disease activity (ESR)
Time Frame: Days 0 and 60
Assessed quantitative valuation of serum inflammatory marker: ESR measured in mm/hr
Days 0 and 60
Effect of SBI on disease activity (CRP)
Time Frame: Days 0, 15, 60 and 90
Assessed quantitative valuation of serum inflammatory marker: CRP measured in mg/L
Days 0, 15, 60 and 90
Effect of SBI on disease activity (calprotectin)
Time Frame: Days 0 and 60
Assessed quantitative valuation of fecal inflammatory marker: calprotectin measured in ug/g
Days 0 and 60
Effect of SBI on stool microbiota
Time Frame: 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
Days 0 and 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monisha Hitesh Shah

Investigators

  • Principal Investigator: Monisha Shah, M.D., The University of Texas Health Science Center, Houston
  • Study Director: Jon Marc Rhoads, M.D., The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2020

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-19-0998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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