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A Phase One Safety Study of Lactobacillus reuteri Conducted in the Peruvian Amazon: Observations from the Field

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  • Tulane School of Public Health and Tropical Medicine, New Orleans, Louisiana; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica Prisma, Unidad de Investigaciones Biomédicas, Iquitos, Peru; Infant Bacterial Therapeutics AB, Gamla Brogatan 11, 111 20 Stockholm, Sweden

Clinical research on probiotics presents challenging issues for researchers, regulators, and funding agencies, and these issues become more complex when United States federally funded research is conducted outside the United States. Here, we describe the design and results of a Phase I safety study of Lactobacillus reuteri DSM 17938 conducted as a community-based trial under the Food and Drug Administration Investigative New Drug (FDA IND) program in a small town in the Peruvian Amazon. Forty-five healthy adults 18 to 65 years of age were randomized in a 2:1 ratio to receive either Lactobacillus reuteri 108 organisms once daily for 5 days or an identical appearing placebo. Results showed no evidence of invasive infection resulting from probiotic administration and no differences between groups. Although we encountered several challenges in conducting an FDA-approved safety trial in this setting, the rigorously collected contextually relevant data will be very valuable to support later Phase II/III studies of L. reuteri for use in similar settings.

Author Notes

* Address correspondence to Richard A. Oberhelman, 1440 Canal Street, Suite 2210, New Orleans, LA 70112. E-mail: oberhel@tulane.edu

Financial support: The study was supported by a grant from the National Institutes of Health/National Center for Complementary and Alternative Medicine (NIH/NCCAM) 5U01AT002733. The content of this article is solely the work of the authors and does not necessarily represent the official views of the National Institutes of Health/National Center for Complementary and Alternative Medicine (NIH/NCCAM).

Disclosure: Dr. Connolly is employed by Infant Bacterial Therapeutics AB, a subsidiary of BioGaia, the company that produces the L. reuteri probiotic evaluated in this trial. This statement is being made in the interest of full disclosure and not because the authors consider this to be a conflict of interest.

Authors' addresses: Richard A. Oberhelman, Tulane School of Public Health and Tropical Medicine, New Orleans, LA, E-mail: oberhel@tulane.edu. Margaret N. Kosek, Johns Hopkins School of Public Health, International Health, Baltimore, MD, E-mail: mkosek@jhsph.edu. Pablo Peñataro-Yori, Johns Hopkins Bloomberg School of Public Health, Department of International Health, Baltimore, MD, and Asociación Benéfica Prisma, Unidad de Investigaciones Biomédicas, Calle Ramirez Hurtado, Iquitos, Maynas, Peru, E-mail: pyori@jhsph.edu. Maribel Paredes-Olórtegui, Asociacion Benefica PRISMA, Investigaciones Biomedicas, Iquitos, Peru, E-mail: mparedeso@prisma.org.pe. Eamonn Connolly, Infant Bacterial Therapeutics AB - N/A, Stockholm, Sweden, E-mail: eamonn.connolly@ibtherapeutics.com.

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