title: Dose-response effect of Bifidobacterium lactis HN019 on whole gut transit time and functional gastrointestinal symptoms in adults.
abstract: OBJECTIVE
  To assess the impact of Bifidobacterium lactis HN019 supplementation on whole gut transit time (WGTT) and frequency of functional gastrointestinal (GI) symptoms in adults.
  
  
  METHODS
  We randomized 100 subjects (mean age: 44 years; 64% female) with functional GI symptoms to consume a proprietary probiotic strain, B. lactis HN019 (Fonterra Research Centre, Palmerston North, New Zealand), at daily doses of 17.2 billion colony forming units (CFU) (high dose; n = 33), 1.8 billion CFU (low dose; n = 33), or placebo (n = 34) for 14 days. The primary endpoint of WGTT was assessed by X-ray on days 0 and 14 and was preceded by consumption of radiopaque markers once a day for 6 days. The secondary endpoint of functional GI symptom frequency was recorded with a subject-reported numeric (1-100) scale before and after supplementation.
  
  
  RESULTS
  Decreases in mean WGTT over the 14-day study period were statistically significant in the high dose group (49 ± 30 to 21 ± 32 h, p < 0.001) and the low dose group (60 ± 33 to 41 ± 39 h, p = 0.01), but not in the placebo group (43 ± 31 to 44 ± 33 h). Time to excretion of all ingested markers was significantly shorter in the treatment groups versus placebo. Of the nine functional GI symptoms investigated, eight significantly decreased in frequency in the high dose group and seven decreased with low dose, while two decreased in the placebo group. No adverse events were reported in any group.
  
  
  CONCLUSIONS
  Daily B. lactis HN019 supplementation is well tolerated, decreases WGTT in a dose-dependent manner, and reduces the frequency of functional GI symptoms in adults.
authors.affiliation: Accurate Clinical Research, Houston, TX, USA.
authors.forename: Philip A
authors.initials: PA
authors.lastname: Waller
authors.forename: Pramod K
authors.initials: PK
authors.lastname: Gopal
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Leyer
authors.forename: Arthur C
authors.initials: AC
authors.lastname: Ouwehand
authors.forename: Cheryl
authors.initials: C
authors.lastname: Reifer
authors.forename: Morgan E
authors.initials: ME
authors.lastname: Stewart
authors.forename: Larry E
authors.initials: LE
authors.lastname: Miller
mesh_terms: D015746:Abdominal Pain / Q000517:prevention & control; D000328:Adult; D000704:Analysis of Variance; D001644:Bifidobacterium; D003248:Constipation / Q000517:prevention & control; D003967:Diarrhea / Q000517:prevention & control; D005260:Female; D005414:Flatulence / Q000517:prevention & control; D041981:Gastrointestinal Tract / Q000000981:diagnostic imaging / Q000502:physiology*; D005772:Gastrointestinal Transit / Q000502:physiology*; D006801:Humans; D057045:Laryngopharyngeal Reflux / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control; D019936:Probiotics / Q000008:administration & dosage* / Q000627:therapeutic use; D011859:Radiography; D014839:Vomiting / Q000517:prevention & control