title: Modulatory effects of Bifidobacterium longum BB536 on defecation in elderly patients receiving enteral feeding.
abstract: OBJECTIVE
  To investigate the effects of the probiotic Bifidobacterium longum BB536 on the health management of elderly patients receiving enteral feeding.
  
  
  METHODS
  Two double-blind, placebo-controlled trials were performed with long-term inpatients receiving enteral tube feeding at Kitakyushu Hospital Group, Fukuoka, Japan. BB536 was administered as BB536-L and BB536-H powders that contained approximately 2.5 × 10¹⁰ and 5 × 10¹⁰ cfu of BB536, respectively. In the first trial, 83 patients (age range: 67-101 years) were randomized into 2 groups that received placebo (placebo group) or BB536-H (BB536 group) powders. In the second trial, 123 patients (age range: 65-102 years) were randomized into 3 groups, and each group received placebo (placebo group), BB536-L (BB536-L group), or BB536-H (BB536-H group) powders. Each patient received the study medication for 16 wk after 1 wk of pre-observation. Fecal samples were collected from each patient prior to and after the intervention during Trial 2. Clinical observations included body temperature, occurrence of infection, frequency of defecation, and fecal microbiota.
  
  
  RESULTS
  No significant changes were observed in the frequency of defecation for either treatment in Trial 1. However, a significant change was noted in the BB536-L group (P = 0.0439) in Trial 2 but not in the placebo or BB536-H groups. Subgroup analyses based on the frequency of defecation for each patient during the pre-observation period for both trials revealed significant increases in bowel movements in patients with a low frequency of defecation and significant decreases in the bowel movements of patients with a high frequency of defecation during the intervention period in the BB536 groups. The combination of Trials 1 and 2 data revealed a modulatory effect of BB536 ingestion on the changes in bowel movements. Significantly increased bowel movements were observed in patients in the low frequency subgroup with significant intergroup differences (P < 0.01). Significantly decreased bowel movements were observed in patients in the high subgroup, but no significant intergroup differences were observed compared with the placebo group. BB536 ingestion increased the prevalence of normally formed stools. BB536 intake also significantly (P < 0.01) increased the cell numbers of bifidobacteria in fecal microbiota, and significant intergroup differences were observed at week 16. No adverse events were reported in any group.
  
  
  CONCLUSIONS
  Our results suggest that BB536 ingestion modulated the intestinal environment and may have improved the health care of elderly patients receiving enteral feeding.
authors.affiliation: Kitakyushu Hospital Group, Fukuoka 803-8501, Japan.
authors.forename: Junko
authors.initials: J
authors.lastname: Kondo
authors.forename: Jin-Zhong
authors.initials: JZ
authors.lastname: Xiao
authors.forename: Akira
authors.initials: A
authors.lastname: Shirahata
authors.forename: Mieko
authors.initials: M
authors.lastname: Baba
authors.forename: Akie
authors.initials: A
authors.lastname: Abe
authors.forename: Koichi
authors.initials: K
authors.lastname: Ogawa
authors.forename: Taeko
authors.initials: T
authors.lastname: Shimoda
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001644:Bifidobacterium / Q000254:growth & development*; D003672:Defecation; D004311:Double-Blind Method; D004750:Enteral Nutrition; D005243:Feces / Q000382:microbiology; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D007297:Inpatients; D007422:Intestines / Q000382:microbiology*; D007564:Japan; D008297:Male; D019936:Probiotics / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Bifidobacterium longum BB536; Defecation; Elderly; Probiotics