Nicole Y Fatheree, Yuying Liu, Melissa Van Arsdall, Juleen Min, Dat Q Tran, Fernando Navarro, Wallace Gleason, Sara Gonzalez, J Marc Rhoads, Department of Pediatrics, the University of Texas Health Science Center at Houston Medical School, Houston, TX 77030, United States
Chunyan Cai, Mohammad H Rahbar, Manouchehr Hessabi, Biostatistics/Epidemiology/Research Design Core, Center for Clinical and Translational Sciences, the University of Texas Health Science Center at Houston, Houston, TX 77030, United States
Chunyan Cai, Mohammad H Rahbar, Manouchehr Hessabi, Division of Epidemiology, Human Genetics and Environmental Sciences, the University of Texas School of Public Health at Houston, Houston, TX 77030, United States
Michael Ferris, Valarie McMurtry, Marcela Zozaya, Department of Pediatrics, Louisiana State University Health Science Center and the Research Institute for Children, New Orleans, LA 70112, United States
Ta Vu, Christine Wong, Investigational Drug Services Pharmacy, Memorial Hermann Hospital, Houston, TX 77030, United States
Author contributions: The first two authors contributed equally to this work and are both considered first authors. Fatheree NY, Liu Y, Rahbar MH and Rhoads JM were integral to the clinical protocol and study design; Fatheree NY, Van Arsdall M, Navarro F, Gleason W and Rhoads JM collected clinical data; Gonzalez S supported research team by providing nutritional expertise; Liu Y provided essential expertise for analyzing cytokines and fecal calprotectin; Min J and Tran DQ conducted research on Treg analysis; Tu V and Wong C provided investigative pharmaceutical expertise during research; Ferris M, McMurty V and Zozoya M provided essential experience and expertise with high throughput sequence analysis of 16S rRNA gene sequences of fecal microbiota; Chunyan C, Rahbar MH and Hessabi M performed data management and statistical analyses; Fatheree NY, Liu Y, Ferris M and Rhoads JM wrote the paper; Rhoads JM has primary responsibility for content; all authors read and approved the final manuscript.
Supported by An Investigator Initiated Trial grant from Mead Johnson Nutrition which had no influence on the design or conduct of the study, data management and analysis, writing of the report, or the decision to submit the manuscript for publication.
Institutional review board statement: The study was reviewed and approved by the University of Texas Health Science Center at Houston Institutional Review Board.
Clinical trial registration statement: This registration policy applies to prospective, randomized, controlled trials only, NCT01279265.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Not declared.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: J Marc Rhoads, MD, Department of Pediatrics, the University of Texas Health Science Center at Houston Medical School, 6431 Fannin St., MSB 3.137, Houston, TX 77030, United States. email@example.com
Telephone: +1-713-5007642 Fax: +1-713-5005750
Received: March 27, 2015
Peer-review started: March 31, 2015
First decision: June 18, 2015
Revised: September 25, 2015
Accepted: November 3, 2015
Article in press: November 4, 2015
Published online: February 15, 2016