title: Hypoallergenic formula with Lactobacillus rhamnosus GG for babies with colic: A pilot study of recruitment, retention, and fecal biomarkers.
abstract: OBJECTIVE
  To investigate recruitment, retention, and estimates for effects of formula supplementation with Lactobacillus rhamnosus GG (LGG) on inflammatory biomarkers and fecal microbial community in infants with colic.
  
  
  METHODS
  A prospective, double-blind, placebo-controlled trial was conducted in otherwise healthy infants with colic. We screened 74 infants and randomized and analyzed results in 20 infants [9 receiving LGG (LGG+) and 11 not receiving LGG (LGG-)]. LGG was incorporated in the formula (Nutramigen(®)) (minimum of 3 × 10(7) CFU/d) in the LGG+ group. Fecal microbiota and inflammatory biomarkers, including fecal calprotectin (FC), plasma cytokines, circulating regulatory T cells (Tregs), and crying + fussing time were analyzed to determine optimal time points and effect sizes for a larger trial.
  
  
  RESULTS
  Recruitment in this population was slow, with about 66% of eligible infants willing to enroll; subject retention was better (75%). These rates were influenced by parents' reluctance to volunteer their infant for a clinical trial and by their tendency to change formulas. The maximal difference of crying + fussing time was observed at day 14, comparing the 2 groups, with a mean difference of -91 (95%CI: -76, 259) min (P = NS). FC showed no significant difference, but the optimal time to determine a potential effect was at day 90 [with a mean difference of 121 (95%CI: -48, 291) μg/g stool], observing a lower level of FC in the LGG+ group. The fecal microbial communities were chaotic, as determined by Shannon's diversity index and not apparently influenced by the probiotic. No significant change was observed in plasma inflammatory cytokines or Tregs, comparing LGG+ to LGG- groups.
  
  
  CONCLUSIONS
  Designing future colic trials involving a probiotic-supplemented formula for infants in the United States will require consideration for difficult enrollment. Infants with colic have major variations in feal microbiota and calprotectin, both of which improve with time, with optimal time points for measurement at days 14 and 90 after treatment.
authors.affiliation: 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.
authors.forename: Nicole Y
authors.initials: NY
authors.lastname: Fatheree
authors.affiliation: 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.
authors.forename: Yuying
authors.initials: Y
authors.lastname: Liu
authors.affiliation: 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.
authors.forename: Michael
authors.initials: M
authors.lastname: Ferris
authors.affiliation: 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.
authors.forename: Melissa
authors.initials: M
authors.lastname: Van Arsdall
authors.affiliation: 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.
authors.forename: Valarie
authors.initials: V
authors.lastname: McMurtry
authors.affiliation: 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.
authors.forename: Marcela
authors.initials: M
authors.lastname: Zozaya
authors.affiliation: 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.
authors.forename: Chunyan
authors.initials: C
authors.lastname: Cai
authors.affiliation: 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.
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Rahbar
authors.affiliation: 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.
authors.forename: Manouchehr
authors.initials: M
authors.lastname: Hessabi
authors.affiliation: 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.
authors.forename: Ta
authors.initials: T
authors.lastname: Vu
authors.affiliation: 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.
authors.forename: Christine
authors.initials: C
authors.lastname: Wong
authors.affiliation: 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.
authors.forename: Juleen
authors.initials: J
authors.lastname: Min
authors.affiliation: 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.
authors.forename: Dat Q
authors.initials: DQ
authors.lastname: Tran
authors.affiliation: 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.
authors.forename: Fernando
authors.initials: F
authors.lastname: Navarro
authors.affiliation: 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.
authors.forename: Wallace
authors.initials: W
authors.lastname: Gleason
authors.affiliation: 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.
authors.forename: Sara
authors.initials: S
authors.lastname: Gonzalez
authors.affiliation: 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.
authors.forename: J Marc
authors.initials: JM
authors.lastname: Rhoads
keywords: Barr diary; Biomarker; Crying; Cytokines; Fussing; Inflammation; Intestine; Newborn; Probiotic; Regulatory T cells