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

Arm | Intervention/treatment |
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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
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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
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Dietary Supplement: Placebo
Hydrolyzed Collagen |
- 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)
- 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
- Effects of SBI on nutritional marker: pre-albumin [ Time Frame: Days 0 and 60 ]Assessed quantitative valuation of pre-albumin level in mg/dL
- Effects of SBI on nutritional markers: transferrin and iron saturation [ Time Frame: Days 0 and 60 ]Assessed quantitative valuation of iron panel
- Effects of SBI on weight [ Time Frame: Days 0, 15, 60 and 90 ]Assessed quantitative valuation of weight in kilograms
- 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
- 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
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 6 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
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 |
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. |
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 of Results:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
serum bovine immunoglobulin |
Crohn Disease Intestinal Diseases Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Immunoglobulins Immunoglobulins, Intravenous Antibodies Immunologic Factors Physiological Effects of Drugs |