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

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ClinicalTrials.gov Identifier: NCT04223518
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Monisha Hitesh Shah, The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease Dietary Supplement: Serum bovine immunoglobulin Dietary Supplement: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, randomized control double blinded prospective clinical trial
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease
Actual Study Start Date : September 20, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Effects of SBI on nutritional marker: pre-albumin [ Time Frame: Days 0 and 60 ]
    Assessed quantitative valuation of pre-albumin level in mg/dL

  3. Effects of SBI on nutritional markers: transferrin and iron saturation [ Time Frame: Days 0 and 60 ]
    Assessed quantitative valuation of iron panel

  4. Effects of SBI on weight [ Time Frame: Days 0, 15, 60 and 90 ]
    Assessed quantitative valuation of weight in kilograms

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223518


Contacts
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Contact: Monisha Shah, M.D. 713-500-5669 Monisha.Shah.1@uth.tmc.edu
Contact: Nicole Fatheree, BBA 713-500-5669 nicole.fatheree@uth.tmc.edu

Locations
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United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Monisha Shah, MD    713-500-5663    Monisha.Shah.1@uth.tmc.edu   
Contact: Nicole Y. Fatheree, BBA    713-500-5669    nicole.fatheree@uth.tmc.edu   
Sub-Investigator: J. Marc Rhoads, M.D.         
Principal Investigator: Monisha Shah, M.D.         
Sponsors and Collaborators
Monisha Hitesh Shah
Investigators
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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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Monisha Hitesh Shah, M.D., Fellow, Pediatric Gastroenterology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04223518    
Other Study ID Numbers: HSC-MS-19-0998
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monisha Hitesh Shah, The University of Texas Health Science Center, Houston:
serum bovine immunoglobulin
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs