The launch of the Human Microbiome Project (HMP), and the corresponding interest in bioengineered probiotic therapies that this new NIH initiative is likely to generate, provide a unique opportunity for research examining ethical and social considerations in the introduction of new therapeutic modalities. To date, analysis of ethical and social considerations in the use of probiotics have focused on """"""""over the counter"""""""" applications where physician involvement in the selection and administration of the probiotic is limited. As new probiotic therapies become a part of the clinician's arsenel, it is important to consider how patients may perceive and respond to new probiotic therapies that are recommended by their physicians. To be successfully integrated into patient care, it is critical that patient attitudes and beliefs regarding bioengineered probiotics be well characterized. Studies of patient perceptions of therapeutic probiotics may reveal common misconceptions about probiotic therapies and/or widespead concerns that may limit patient enthusiasm for new therapeutic options. This research project will characterize patient perceptions of bioengineered probiotics and other potential clinical applications of metagenomic analyses of the human microbiome. Empirical results from the project will be presented to a Working Group of national experts in gastroenterology, biomedical ethics, health policy, and patient advocacy, who will identify opportunities to promote the responsible introduction of bioengineered probiotics into the care of patients with debilitating gastrointestinal diseases. These strategies will focus on potential health-policy initiatives and educational interventions that gastroenterologists, patient educators, and voluntary-health organizations can undertake now in anticipation of the time when bioengineered probiotic therapies may be appropriate for routine clinical use.

Public Health Relevance

This research study will examine patient perceptions of bioengineered probiotics and other potential clinical applications of metagenomic analyses of the human microbiome. Systematic data on patient attitudes and beliefs about emerging therapeutic interventions facilitated by the Human Microbiome Project are critically important, as these data can identify potential barriers to the successful integration of bioengineered probiotics into patient care and improve physician-patient communication about new therapeutic options. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project (R01)
Project #
1R01HG004877-01
Application #
7572423
Study Section
Special Emphasis Panel (ZRG1-GGG-E (52))
Program Officer
Mcewen, Jean
Project Start
2008-09-23
Project End
2011-07-31
Budget Start
2008-09-23
Budget End
2009-07-31
Support Year
1
Fiscal Year
2008
Total Cost
$402,162
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Other Basic Sciences
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
Harrison, Krista L; Farrell, Ruth M; Brinich, Margaret A et al. (2015) 'Someone should oversee it': patient perspectives on the ethical issues arising with the regulation of probiotics. Health Expect 18:250-61
Brinich, Margaret A; Mercer, Mary Beth; Sharp, Richard R (2013) An analysis of online messages about probiotics. BMC Gastroenterol 13:5
Human Microbiome Project Consortium (2012) Structure, function and diversity of the healthy human microbiome. Nature 486:207-14
Harrison, Krista L; Geller, Gail; Marshall, Patricia et al. (2012) Ethical Discourse about the Modification of Food for Therapeutic Purposes: How Patients with Gastrointestinal Diseases View the Good, the Bad, and the Healthy. AJOB Prim Res 3:12-20
McCormick, Jennifer B; Hammer, Rachel R; Farrell, Ruth M et al. (2012) Experiences of patients with chronic gastrointestinal conditions: in their own words. Health Qual Life Outcomes 10:25
Human Microbiome Project Consortium (2012) A framework for human microbiome research. Nature 486:215-21
Mercer, MaryBeth; Brinich, Margaret A; Geller, Gail et al. (2012) How patients view probiotics: findings from a multicenter study of patients with inflammatory bowel disease and irritable bowel syndrome. J Clin Gastroenterol 46:138-44
Sharp, Richard R; Achkar, Jean-Paul; Brinich, Margaret A et al. (2009) Helping patients make informed choices about probiotics: a need for research. Am J Gastroenterol 104:809-13