Management of inflammatory bowel disease with oral serum-derived bovine immunoglobulin

Shafran, Ira; Burgunder, Patricia; Wei, David; Young, Hayley; Klein, Gerald L.; Burnett, Bruce

doi:10.1177/1756283x15593693

Cited by 21 publications

(19 citation statements)

References 29 publications

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“…Indeed, a number of clinical reports have described the effectiveness of SBI for managing the chronic loose and frequent stools found in these conditions. 18,19,21,30 Our results also showed an improvement in stool consistency leading to a reduction in the number of daily unformed stools in HIV-infected participants after 1 week of SBI treatment. Study participants also reported significant improvements in several other GI symptoms.…”

Section: Efficacy -Symptom Diary Scoressupporting

confidence: 61%

Evaluation of oral serum-derived bovine immunoglobulins in HIV-infected patients with chronic idiopathic diarrhea

Asmuth

Hinkle²,

LaMarca

et al. 2017

HIV Clinical Trials

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Section: Efficacy -Symptom Diary Scoressupporting

confidence: 61%

Evaluation of oral serum-derived bovine immunoglobulins in HIV-infected patients with chronic idiopathic diarrhea

Asmuth

Hinkle²,

LaMarca

et al. 2017

HIV Clinical Trials

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“…Other adult IBD studies support similar results [5, 6]. A recent case report of a 13-year-old pediatric UC patient has also been presented, demonstrating clinical and inflammatory remission based on complete disappearance of symptoms within 4 weeks and decreased fecal calprotectin from >1,700 to <15 μg/g after 3 months of SBI use when added to other standard treatments [7].…”

Section: Introductionsupporting

confidence: 61%

Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen

Soriano

Ramos-Soriano

2017

Case Rep Gastroenterol

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Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is particularly troublesome for pediatric patients, as current therapeutic options consist of biologic agents and steroids which alter the immune response and have the harmful side effect of leaving the patient more susceptible to opportunistic infections and eventual surgery. Another option for therapy exists in the form of serum-derived bovine immunoglobulin/protein isolate (SBI), the key ingredient in a medical food, EnteraGam®. The FDA has reviewed the safety of SBI and issued a no challenge letter to the generally recognized as safe (GRAS) findings for this medical food. The product also has no known food or drug interactions, no significant adverse effects, and no contraindications, save for beef allergy. SBI has been shown to induce clinical remission in adult populations and to decrease markers of inflammation in pediatric patients. Here, we present a detailed case of pediatric UC, including documentation of mucosal healing and decrease in pediatric UC activity index in a difficult to treat pediatric patient, after the addition of SBI to this patient’s treatment regimen.

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“…Hence, further understanding of the clinical benefits with SBI therapy is required, while exploring the putative mechanisms of action of SBI, the goal of this study. In patients with IBS‐D following recurrent C.difficile infection, SBI restored normal bowel function in two patients treated in open‐label fashion (Crawford and Panas, ), suggesting potential effects on barrier function, mucosal immune function or, conceivably, the microbiome, but clearly requiring more rigorous study. In a single‐center, retrospective chart review of 45 patients with inflammatory bowel disease (38 Crohn's disease and 7 ulcerative colitis)) with limited to no response to traditional pharmaceutical therapies, the medical food, SBI, has been shown to improve symptom scores and clinical management (Shafran et al. ). SBI has been shown to bind and neutralize microbial components (Tomita et al. ; Navarro et al.…”

Section: Introductionmentioning

confidence: 99%

Potential mechanisms of effects of serum‐derived bovine immunoglobulin/protein isolate therapy in patients with diarrhea‐predominant irritable bowel syndrome

Valentin

Camilleri

Carlson

et al. 2017

Physiological Reports

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Serum‐derived bovine immunoglobulin/protein isolate (SBI), an oral nutritional therapy, is efficacious in diverse diarrheal diseases. In an open‐label study in 15 patients with irritable bowel syndrome‐diarrhea (IBS‐D), we evaluated effects of SBI (5.0 g, twice a day) for 8 weeks on safety, on bowel function and abdominal pain, tryptophan metabolism (K:T ratio), intestinal permeability (13C‐mannitol and lactulose excretion), bile acid synthesis (fasting serum FGF‐19 and C4), duodenal and stool microbiome, and the expression of 90 genes related to inflammation, immune function, and tight junctions in duodenal mucosa. Statistical analysis (paired tests, baseline vs. treatment) was based on intention to treat (ITT) principles. One of 15 Caucasian patients (13F, 2M, age 40.3 ± 2.3y, BMI 34.3 ± 3.0 kg/m2) withdrew without completing studies. There were improvements in stools/day (decrease, P < 0.001), ease of passage (P = 0.035), and evacuation (P = 0.004) with SBI therapy. Worst pain severity was numerically reduced in last 2 weeks' treatment (P = 0.078). Duodenal mucosal mRNA expression; serum C4, FGF‐19, and KT ratio; small bowel or colon permeability; and stool microbiome were not significantly different after SBI therapy, compared to baseline. In duodenal brushings, there was considerable microbiota structure difference (β diversity analysis P = 0.072, UniFrac) and, on taxonomic analysis, increased abundance of Proteobacteria Burkholderiales, Firmicutes Catonella, and unclassified genus organisms with SBI therapy. Thus, SBI therapy for 8 weeks in IBS‐D patients is associated with improved bowel function; the mechanism of benefit is unclear, though there were microbiota structure differences in duodenal brushings. Further studies in patients with low‐grade inflammation and intestinal barrier dysfunction at baseline are indicated.

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Management of inflammatory bowel disease with oral serum-derived bovine immunoglobulin

Abstract: These results suggest that SBI improves clinical management of IBD patients who are not fully managed on traditional therapies. SBI should be considered for the nutritional support of IBD regardless of disease activity, location, phenotype, duration, or complexity.

Cited by 21 publications

References 29 publications

Evaluation of oral serum-derived bovine immunoglobulins in HIV-infected patients with chronic idiopathic diarrhea

Evaluation of oral serum-derived bovine immunoglobulins in HIV-infected patients with chronic idiopathic diarrhea

Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen

Potential mechanisms of effects of serum‐derived bovine immunoglobulin/protein isolate therapy in patients with diarrhea‐predominant irritable bowel syndrome

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