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US National Institutes of Health – Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01 Clinical Trial Optional) – PA-18-902
Sponsor: US National Institutes of Health 		Closing Date: 05-Feb-2019
The purpose of this funding opportunity announcement (FOA) is twofold: 1) to accelerate translational and clinical Phase I and II a/b safety and efficacy studies for substantiating measurable functional benefits of probiotic/prebiotic components and/or their combinations; and 2) to understand the underlying mechanisms of their action(s), and variability in responses to these interventions.

This FOA calls for interdisciplinary collaborations across scientific disciplines engaged in microbiome and pro/prebiotic research including, but not limited to: nutritional science, microbiology, virology, microecology and microbiome, genomics, immunology, computational biology, chemistry, bioengineering, as well as integration of omics and computational approaches in DNA technologies.

Common NIH research areas of interest may include, but are not limited to and are not in any priority order, the following:
• Identification of the underlying mechanisms of action of pro/prebiotic formulation(s) to prevent and/or treat human diseases including conditions caused by emerging pathogens, such as bacteria, fungi and viruses.
• Studies of pro/prebiotics interventions on: microbial composition, co-metabolism, microbial-host interactions, and microbiome resilience, as it affects local and systemic metabolism, gene expression and signaling pathways.
• Interactions of pro/prebiotic formulations with diet, dietary supplements and/or dietary components, which produce microbial metabolites with measurable effects in risk reduction and disease prevention.
• Development of predictive models to understand variability in response to pro/prebiotic interventions, as influenced by variables such as: nutritional status, dietary patterns, health status, age, gender, race, or other factors.
• Characterization of probiotic strain activities on glycans and identification of glycan-mediated signaling pathways in health and disease, including further clarification of the effect of probiotics on mucin degradation and its consequences.
• Examination of the effects of drug abuse (narcotics/opiates) on the efficacy of pre/probiotics and intestinal microbiome/microflora in populations with co-occurring infections including HIV, HCV and others; study how manipulation of the microbiome would alter the human virome and pathogenesis of complications of drug use such as HIV, HCV-related disease, and interactions with pro/prebiotics.
• Studies of probiotics pharmacokinetics/pharmacodynamics in healthy and immunocompromised subjects.
• Development and validation of diagnostic tests and biomarkers to evaluate early response to pro/prebiotics interventions.
• Analysis of pro/prebiotic effect on resident biofilm-growing pathogens.
• Analysis of interaction between pro/prebiotics with medications including antibiotics and other chemotherapeutic agents as it relates to bioavailability, treatment outcome, efficacy and adverse events.
• Metabolomic profiling in samples from individuals/populations undergoing pro/prebiotic intervention to identify individuals/populations susceptible to the intervention.
• Microbial comparison of oral cavity and gut of individuals undergoing pro/prebiotic intervention.

Eligibility
• Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply
• Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Funding
• Application budgets are not limited but need to reflect the actual needs of the proposed project. Applicants requesting USD $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/Research Contact at the NIH at least 6 weeks before submitting the application.
• The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Please see the Funding Opportunity Announcement for further information. Applications may be prepared and submitted via the NIH ASSIST system or Grants.gov. For complete instructions, you must refer to both the NIH Application Guide and the Funding Opportunity Announcement (FOA), noting that instructions in the FOA take precedence over the Application Guide.

Key Dates
Letter of Intent (non-mandatory) due to NIH: Not Applicable
Applications due to UQR&I: 22 January 2019
Applications close with NIH: 5 February 2019, 5:00pm local time of applicant organisation
Future application closing dates: Standard dates apply until expiry
Expiration date of FOA: 8 September 2021

Ahead of internal review, ensure all online components on ASSIST or Grants.gov are complete. To initiate review, email your completed Funding Application Coversheet to internationalgrants@research.uq.edu.au. Interested applicants are strongly encouraged to make contact with the UQR&I international team (via internationalgrants@research.uq.edu.au) well in advance of the UQR&I internal deadline to discuss their application.
Website: http://grants.nih.gov/grants/guide/pa-files/PA-18-902.html

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