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Case Series of 10 Drug-Refractory IBS Patients Who Respond to Oral Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI)

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DOI: 10.4236/ojgas.2014.410046    2,718 Downloads   3,622 Views   Citations

ABSTRACT

Aim: The responses of 10 patients with long-standing, symptomatic, intractable drug-refractory histories of irritable bowel syndrome with diarrhea (IBS-D) and with abdominal pain, gas/bloating and distention, termed IBS undefined (IBS-U), were evaluated when administering a medical food product containing serum-derived bovine immunoglobulin/protein isolate (SBI). Methods: Patients in this case series were chosen based on their lack of satisfactory response to a variety of drugs, including antidiarrheal and antispasmodic medications, serotonin 5-HT3 receptor antagonists, selective serotonin re-uptake inhibitors (SSRIs), proton pump inhibitors (PPIs), antibiotics, and antidepressive drugs. Patients met Rome III criteria and were administered 5 g/day of SBI as standard-of-care nutritional support. A scale of 0% - 25%, 25% - 50%, 50% - 75%, 75% - 100% response to SBI was used for patient-reported improvement in overall IBS symptoms following administration for one month. Exact methods for calculating confidence intervals and p-values were used to assess complete management of symptoms and response to therapy. Adverse events were also monitored for this nutritional product. Results: The onset of gastrointestinal (GI) symptom reduction utilizing nutritional management with SBI occurred within an average time of 2-4 weeks with improved or near complete management in all 10 patients who were refractory to previous drug therapies by 4 weeks. When prompted, patients reported significant IBS symptom improvement which averaged between 50% - 100% (p = 0.002) with an average for complete management in all patients of 69%. No side effects were reported after SBI administration even when taken for up to 28 weeks. Conclusion: Based on the safety profile and reported outcomes in this case report, SBI should be considered as a nutritional option for management in IBS-D and IBS-U.

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Hilal, R. , Mitchell, P. , Guerra Jr., E. and Burnett, B. (2014) Case Series of 10 Drug-Refractory IBS Patients Who Respond to Oral Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI). Open Journal of Gastroenterology, 4, 321-328. doi: 10.4236/ojgas.2014.410046.

References

[1] Lovell, R.M. and Ford, A.C. (2012) Prevalence of Gastro-Esophageal Reflux-Type Symptoms in Individuals with Irritable Bowel Syndrome in the Community: A Meta-Analysis. The American Journal of Gastroenterology, 107, 1793-1801.
http://dx.doi.org/10.1038/ajg.2012.336
[2] Choung, R.S. and Locke, G.R. (2012) Epidemiology of IBS. Gastroenterology Clinics of North America, 40, 1-10.
http://dx.doi.org/10.1016/j.gtc.2010.12.006
[3] Quigley, E.M., et al. (2012) A global Perspective on Irritable Bowel Syndrome: A Consensus Statement of the World Gastroenterology Organisation Summit Task Force on Irritable Bowel Syndrome. Journal of Clinical Gastroenterology, 46, 356-366.
http://dx.doi.org/10.1097/MCG.0b013e318247157c
[4] Hungin, A.P.S., Chang, L., Locke, G.R., Dennis, E.H. and Barghout, V. (2005) Irritable Bowel Syndrome in the United States: Prevalence, Symptom Patterns and Impact. Alimentary Pharmacology Therapeutics, 21, 1365-1375.
http://dx.doi.org/10.1111/j.1365-2036.2005.02463.x
[5] Drossman, D.A., Camilleri, M., Mayer, E.A. and Whitehead, W.E. (2002) AGA Technical Review on Irritable Bowel Syndrome. Gastroenterology, 123, 2108-2131.
http://dx.doi.org/10.1053/gast.2002.37095
[6] Camilleri, M. (2012) Peripheral Mechanisms in Irritable Bowel Syndrome. The New England Journal of Medicine, 367, 1626-1635.
http://dx.doi.org/10.1056/NEJMra1207068
[7] Drossman, D.A., Morris, C.B., Schneck, S., Hu, Y.J., Norton, N.J., Norton, W.F., Weinland, S.R., Dalton, C., Leserman, J. and Bangdiwala, S.I. (2009) International Survey of Patients with IBS: Symptom Features and Their Severity, Health Status, Treatments, and Risk Taking to Achieve Clinical Benefit. Journal of Clinical Gastroenterology, 43, 541-550.
http://dx.doi.org/10.1097/MCG.0b013e318189a7f9
[8] Magge, S. and Lembo, A. (2012) Low-FODMAP Diet for Treatment of Irritable Bowel Syndrome. Gastroenterol Hepatol (NY), 8, 739-745.
[9] Halmos, E.P., Power, V.A., Shepherd, S.J., Gibson, P.R. and Muir, J.G. (2014) A Diet Low in FODMAPs Reduces Symptoms of Irritable Bowel Syndrome. Gastroenterology, 146, 67-75.
http://dx.doi.org/10.1053/j.gastro.2013.09.046
[10] Hoveyda, N., Heneghan, C., Mahtani, K.R., Perera, R., Roberts, N. and Glasziou, P. (2009) A Systematic Review and Meta-Analysis: Probiotics in the Treatment of Irritable Bowel Syndrome. BMC Gastroenterol, 9, 15.
http://dx.doi.org/10.1186/1471-230X-9-15
[11] Olden, K.W. (2012) Targeted Therapies for Diarrhea-Predominant Irritable Bowel Syndrome. Clinical and Experimental Gastroenterology, 5, 69-100.
http://dx.doi.org/10.2147/CEG.S29023
[12] Petschow, B.W., Burnett, B.P., Shaw, A.L., Weaver, E.M. and Klein, G.L. (2014) Dietary Requirement for Serum-Derived Bovine Immunoglobulins in the Clinical Management of Patients with Enteropathy. Digestive Diseases and Sciences, Published Online.
http://link.springer.com/article/10.1007%2Fs10620-014-3322-0
http://dx.doi.org/10.1007/s10620-014-3322-0
[13] Wilson, D., Evans, M.D., Weaver, E., Shaw, A.L. and Klein, G.L. (2013) Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome. Clinical Medicine Insights: Gastroenterology, 6, 49-60.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4020402/pdf/cgast-6-2013-049.pdf
[14] Longstreth, G.F., Thompson, W.G., Chey, W.E., Houghton, L.A., Mearin, F. and Spiller, R.C. (2006) Functional Bowel Disorders. In: Drossman, D.A., Corazziari, E., Delvaux, M., Spiller, R.C., Talley, N.J., Thompson, W.G., et al., Eds., Rome III: The Functional Gastrointestinal Disorders, 3rd Edition, Degnon Associates, McLean, 487-555.
[15] Talley, N.J., Gabriel, S.E., Harmsen, W.S., Zinsmeister, A.R. and Evans, R.W. (1995) Medical Costs in Community Subjects with Irritable Bowel Syndrome. Gastroenterology, 109, 1736-1741.
http://dx.doi.org/10.1016/0016-5085(95)90738-6
[16] American Gastroenterological Association (2001) The Burden of Gastrointestinal Diseases. American Gastroenterological Association, Bethesda, 1-86.
http://www.lewin.com/~/media/Lewin/Site_Sections/Publications/2695.pdf
[17] Martin, R., Barron, J.J. and Zacker, C. (2001) Irritable Bowel Syndrome: Toward a Cost-Effective Management Approach. The American Journal of Managed Care, 7, S268-S275.
[18] Longstreth, G.F., Wilson, A., Knight, K., Wong, J., Chiou, C.F., Barghout, V., Frech, F. and Ofman, J.J. (2003) Irritable Bowel Syndrome, Healthcare Use, and Costs: A US Managed Care Perspective. The American Journal of Gastroenterology, 98, 600-607.
http://dx.doi.org/10.1111/j.1572-0241.2003.07296.x
[19] Lieberman, D.A., Holub, J., Eisen, G., Kraemer, D. and Morris, C.D. (2005) Utilization of Colonoscopy in the United States: Results from a National Consortium. Gastrointestinal Endoscopy, 62, 875-883.
http://dx.doi.org/10.1016/j.gie.2005.06.037
[20] Longstreth, G.F. and Yao, J.F. (2004) Irritable Bowel Syndrome and Surgery: A Multivariable Analysis. Gastroenterology, 126, 1665-1673.
http://dx.doi.org/10.1053/j.gastro.2004.02.020
[21] Miller, A.R., North, C.S., Clouse, R.E., Wetzel, R.D., Spitznagel, E.L. and Alpers, D.H. (2001) The Association of Irritable Bowel Syndrome and Somatization Disorder. Annals of Clinical Psychiatry, 13, 25-30.
http://dx.doi.org/10.3109/10401230109147126
[22] Whitehead, W.E., Palsson, O. and Jones, K.R. (2002) Systematic Review of the Comorbidity of Irritable Bowel Syndrome with Other Disorders: What Are the Causes and Implications? Gastroenterology, 122, 1140-1156.
http://dx.doi.org/10.1053/gast.2002.32392
[23] Gralnek, I.M., Hays, R.D., Kilbourne, A., Naliboff, B. and Mayer, E.A. (2000) The Impact of Irritable Bowel Syndrome on Health-Related Quality of Life. Gastroenterology, 119, 654-660.
http://dx.doi.org/10.1053/gast.2000.16484
[24] Whitehead, W.E., Palsson, O.S., Levy, R.R., Feld, A.D., Turner, M. and Von Korff, M. (2007) Comorbidity in Irritable Bowel Syndrome. The American Journal of Gastroenterology, 102, 2767-2776.
http://dx.doi.org/10.1111/j.1572-0241.2007.01540.x
[25] Jarrett, M., Heitkemper, M., Cain, K.C., Burr, R.L. and Hertig, V. (2000) Sleep Disturbance Influences Gastrointestinal Symptoms in Women with Irritable Bowel Syndrome. Digestive Diseases and Sciences, 45, 952-959.
http://dx.doi.org/10.1023/A:1005581226265
[26] Chang, F.Y. and Lu, C.L. (2013) Irritable Bowel Syndrome and Migraine: Bystanders or Partners? Journal of Neurogastroenterology and Motillity, 19, 301-311.
http://dx.doi.org/10.5056/jnm.2013.19.3.301
[27] Sperber, A.D., Akiva, S., Leshno, M., Halpern, Z. and Buskila, D. (2011) Validation of New Symptom-Based Fibromyalgia Criteria for Irritable Bowel Syndrome Co-Morbidity Studies. Journal of Neurogastroenterology and Motillity, 17, 67-72.
http://dx.doi.org/10.5056/jnm.2011.17.1.67
[28] Lydiard, R.B., Fossey, M.D., Marsh, W. and Ballenger, J.C. (1993) Prevalence of Psychiatric Disorders in Patients with Irritable Bowel Syndrome. Psychosomatics, 34, 229-234.
http://dx.doi.org/10.1016/S0033-3182(93)71884-8
[29] de Bortoli, N., Martinucci, I., Bellini, M., Savarino, E., Savarino, V., Blandizzi, C. and Marchi, S. (2013) Overlap of Functional Heartburn and Gastroesophageal Reflux Disease with Irritable Bowel Syndrome. World Journal of Gastroenterology, 19, 5787-5797.
http://dx.doi.org/10.3748/wjg.v19.i35.5787
[30] Frissora, C.L. and Koch, K.L. (2005) Symptom Overlap and Comorbidity of Irritable Bowel Syndrome with Other Conditions. Current Gastroenterology Reports, 7, 264-271.
http://dx.doi.org/10.1007/s11894-005-0018-9
[31] Petschow, B.W., Burnett, B., Shaw, A.L., Weaver, E.M. and Klein, G.L. (2014) Serum-Derived Bovine Immunoglobulin/Protein Isolate: Postulated Mechanism of Action for Management of Enteropathy. Clinical and Experimental Gastroenterology, 7, 181-190.
http://dx.doi.org/10.2147/CEG.S62823

  
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