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

NCT04223518 | Terminated Early Phase 1 DMC

• 1 other identifier: HSC-MS-19-0998
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Keywords

serum bovine immunoglobulin

Outcome Measures

Primary Outcomes (1)

• Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease

  Assessed by a change in albumin by at least 5% (primary end point)

  Days 0, 15, 60 and 90

Secondary Outcomes (13)

• Effects of SBI on nutritional marker: Vitamin D

  Days 0 and 60

• Effects of SBI on nutritional marker: pre-albumin

  Days 0 and 60

• Effects of SBI on nutritional markers: transferrin and iron saturation

  Days 0 and 60

• Effects of SBI on weight

  Days 0, 15, 60 and 90

• Effects of SBI on Body Mass Index (BMI)

  Days 0, 15, 60 and 90

Study Arms (2)

Serum Bovine Immunoglobulin

ACTIVE COMPARATOR

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

Hydrolyzed Collagen

PLACEBO COMPARATOR

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

Interventions

Serum bovine immunoglobulin DIETARY_SUPPLEMENT

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.

Also known as: Enteragam

Serum Bovine Immunoglobulin

Placebo DIETARY_SUPPLEMENT

Hydrolyzed Collagen

Hydrolyzed Collagen

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monisha Hitesh Shah: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (7)

• Arrouk R, Herdes RE, Karpinski AC, Hyman PE. Serum-derived bovine immunoglobulin for children with diarrhea-predominant irritable bowel syndrome. Pediatric Health Med Ther. 2018 Oct 24;9:129-133. doi: 10.2147/PHMT.S159925. eCollection 2018.

  PMID: 30498390 RESULT

• Liaquat H, Ashat M, Stocker A, McElmurray L, Beatty K, Abell TL, Dryden G. Clinical Efficacy of Serum-Derived Bovine Immunoglobulin in Patients With Refractory Inflammatory Bowel Disease. Am J Med Sci. 2018 Dec;356(6):531-536. doi: 10.1016/j.amjms.2018.08.019. Epub 2018 Sep 5.

  PMID: 30342719 RESULT

• Soriano RA, Ramos-Soriano AG. Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen. Case Rep Gastroenterol. 2017 May 19;11(2):335-343. doi: 10.1159/000475923. eCollection 2017 May-Aug.

  PMID: 28626380 RESULT

• Shaw AL, Tomanelli A, Bradshaw TP, Petschow BW, Burnett BP. Impact of serum-derived bovine immunoglobulin/protein isolate therapy on irritable bowel syndrome and inflammatory bowel disease: a survey of patient perspective. Patient Prefer Adherence. 2017 May 31;11:1001-1007. doi: 10.2147/PPA.S134792. eCollection 2017.

  PMID: 28615929 RESULT

• Valentin N, Camilleri M, Carlson P, Harrington SC, Eckert D, O'Neill J, Burton D, Chen J, Shaw AL, Acosta A. Potential mechanisms of effects of serum-derived bovine immunoglobulin/protein isolate therapy in patients with diarrhea-predominant irritable bowel syndrome. Physiol Rep. 2017 Mar;5(5):e13170. doi: 10.14814/phy2.13170.

  PMID: 28275113 RESULT

• Perez-Bosque A, Miro L, Maijo M, Polo J, Campbell JM, Russell L, Crenshaw JD, Weaver E, Moreto M. Oral Serum-Derived Bovine Immunoglobulin/Protein Isolate Has Immunomodulatory Effects on the Colon of Mice that Spontaneously Develop Colitis. PLoS One. 2016 May 3;11(5):e0154823. doi: 10.1371/journal.pone.0154823. eCollection 2016.

  PMID: 27139220 RESULT

• Gelfand MS, Burnett BP. Serum-derived bovine immunoglobulin/protein isolate should be considered in patients with HIV gut barrier dysfunction. Infection. 2015 Apr;43(2):253-4. doi: 10.1007/s15010-015-0732-7. Epub 2015 Jan 30. No abstract available.

  PMID: 25633465 RESULT

Related Links

• Official study product website containing detailed information about study product, uses and side effects.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Monisha Shah, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Jon Marc Rhoads, M.D.

  The University of Texas Health Science Center, Houston

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Fellow, Pediatric Gastroenterology

Model Details: Single-center, randomized control double blinded prospective clinical trial

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 10, 2020
• Study Start: September 20, 2020
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)