title: Efficacy and safety of APT198K for the treatment of infantile colic: a pilot study.
abstract: OBJECTIVE
  Comparing efficacy and safety of APT198K (xyloglucan plus heat-killed Lactobacillus reuteri SGL01 and Bifidobacterium brevis SGB01) versus a lactase dietary supplement as first-line treatment of infantile colic.
  
  
  METHODS
  Randomized, multicenter, open-label, parallel group, active-controlled study, in 46 infants aged 3-16 weeks with infantile colic, receiving APT198K or a lactase dietary supplement for 10 days.
  
  
  RESULTS
  Number and duration of crying episodes decreased significantly versus baseline in both groups. On day 8, the mean duration of crying per episode was significantly shorter in the APT198K group compared with the lactase group (9.14 ± 5.34 vs 13.22 ± 5.29 min; p = 0.014) and remained so up to day 11.
  
  
  CONCLUSIONS
  APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic. Further evaluation in larger studies is warranted. Clinical trial registry: EudraCT number 2014-002860-334; https://eudract.ema.europa.eu .
authors.affiliation: Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
authors.affiliation: University of Medicine & Pharmacy Târgu Mureş City, Romania.
authors.forename: Anca
authors.initials: A
authors.lastname: Bacarea
authors.affiliation: University of Medicine & Pharmacy Târgu Mureş City, Romania.
authors.forename: Marius
authors.initials: M
authors.lastname: Marusteri
authors.affiliation: University of Medicine & Pharmacy Târgu Mureş City, Romania.
authors.forename: Vlad
authors.initials: V
authors.lastname: Bacarea
authors.affiliation: Private Practice of Family Medicine, Pitesti City, Romania.
authors.forename: Mariana
authors.initials: M
authors.lastname: Constantin
authors.affiliation: CEBIS International Ltd, Bucharest, Romania.
authors.forename: Mihai
authors.initials: M
authors.lastname: Manolache
mesh_terms: D000009:Abdominal Muscles / Q000187:drug effects; D000284:Administration, Oral; D000069984:Bifidobacterium breve; D003085:Colic / Q000188:drug therapy*; D003448:Crying; D004338:Drug Combinations; D005260:Female; D005414:Flatulence / Q000188:drug therapy; D005483:Flushing / Q000188:drug therapy; D005936:Glucans / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D052200:Limosilactobacillus reuteri; D008297:Male; D010865:Pilot Projects; D011187:Posture; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014990:Xylans / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: C000625070:APT198K; D004338:Drug Combinations; D005936:Glucans; D014990:Xylans; C029353:xyloglucan
keywords: APT198K; Bifidobacterium brevis; Lactobacillus reuteri; infantile colic; lactase; xyloglucan