EnteraGam® Addresses Distinct Nutritional Requirements
Serum-derived bovine immunoglobulin/protein Isolate (SBI) addresses the distinct nutritional requirements in patients with chronic diarrhea and loose stools due to specific intestinal disorders
Chronic diarrhea is frequently associated with several human disease conditions, including diarrhea-predominant irritable bowel syndrome (IBS-D) and HIV infection, and are caused by changes in the lining of the intestinal tract. Such changes disrupt the normal balance of the GI tract, which leads to symptoms of abdominal discomfort, bloating, and abnormal bowel function (e.g., urgency, diarrhea, constipation).
While the causes of intestinal disorders are not well understood, there is evidence to suggest the involvement of heredity, diet, stress, and exposure to foreign substances, toxins, or other environmental insults (including infection). There are dozens of mutated genes, for example, which have been implicated in IBS, a specific enteropathy which affects 10%-20% of the population.1 These mutations can negatively affect the barrier function of the intestine, change the ability to metabolize tryptophan,2 an essential amino acid needed by the body to produce certain chemicals which effect pain perception, and the synthesis and metabolism of bile acids3 which can increase bowel movements.
Modifications in tryptophan, serotonin, and bile acid metabolism, as well as alterations in the intestinal microbiota (bacteria), have been implicated in causing or making symptoms worse in patients with IBS-D. Besides the potential hereditary involvement, changes of the intestinal microbiota (microbes which live in the gut) and gut permeability can limit or impair digestive and absorptive function leading to changes in fluid balance and vitamin production and absorption, and adversely affect digestion of carbohydrates and fats. Poor absorption of key nutrients such as vitamins, minerals, protein, carbohydrates, and fat during chronic diarrhea can lead to malnutrition or chronic under-nutrition and play a central role in patients with intestinal problems. A simple dietary change does not correct these issues in patients with a variety of intestinal disorders.
Role of Immunoglobulins
It is widely recognized that breast milk, the sole source of nutrition for the premature infant, contains a number of proteins (including immunoglobulins). These proteins, along with early exposure to external antigens and bacteria, are critical for establishing the intestinal microbiota, normal immune function, integrity of the gut barrier, and digestive processes in the GI tract.4-7 Studies evaluating specially formulated bovine immunoglobulin preparations have revealed a similar need for immunoglobulins in maintaining gut homeostasis in enteropathy.8-14
Study Data (clinical and nonclinical)
A clinical study supplementing a formulation similar to serum-derived bovine immunoglobulin/protein isolate (SBI), a specially formulated bovine IgG-containing preparation, replacing 25% and 50% of the milk protein of the control diet, provided distinct nutritional support which promoted trends in better carbohydrate and nitrogen absorption, as well as nitrogen retention. Additionally, there was a statistically significant decrease in fat and energy loss in the feces which resulted in a significantly greater absorption of fat and energy in infants who were malnourished,12 a condition that contributes to enteropathy.
In another clinical study comparing a formulation similar to SBI to soy protein at the same level, only SBI demonstrated within group statistically significant management of IBS-D,14 another type of enteropathy. Finally, SBI administered daily to patients with HIV-associated enteropathy provided nutritional support as evidenced by an increase in D-xylose absorption, a marker for nutrient uptake.13 These results appear to demonstrate that SBI, a specially formulated bovine-IgG preparation, provides for a distinct nutritional requirement induced by enteropathies in different clinical populations.
Nonclinical studies corroborate the clinical findings with regard to addressing a distinct dietary requirement for immunoglobulin-containing preparations for restoring a normal homeostasis to the gut. In a review of data from 75 studies in 43 publications involving over 12,000 piglets (which are prone to developing intestinal disorders during the critical weaning period)15 the addition of plasma protein concentrates to normal feed provided high levels of immunoglobulins similar to levels found in SBI. Nutritional status improved only in piglets fed immunoglobulin-containing protein formulations which increased nutrient ingestion, digestion, absorption, and metabolism of feed and certain nutrients when compared to a range of other proteins added to feed (i.e., from dairy, fish, soy, and other vegetable sources).8 Other models of environmental stress, including viral infection and GI toxin exposure, demonstrated that only bovine plasma containing high levels of immunoglobulin managed enteropathy in weanling pigs compared to soy protein at the same level, as well as in rats when added and compared to normal feed, respectively.16-18
Taken together, results from clinical and nonclinical studies appear to reveal a distinct dietary requirement for immunoglobulins for the purpose of nutritional support in maintaining homeostasis to the disrupted gut environment.