title: The use of probiotics in healthy volunteers with evacuation disorders and hard stools: a double-blind, randomized, placebo-controlled study.
abstract: BACKGROUND
  Evacuation disorders and hard stools are common in industrialized countries, affecting on average 12% to 17% of the adult healthy population at any age. Dietary supplementation with probiotic microorganisms may be useful in reducing the disorder.
  
  
  METHODS
  We performed a double-blind, randomized, placebo-controlled study to evaluate the effectiveness of 2 different probiotic blends, either mixed Lactobacillus plantarum LP01 (LMG P-21021) and Bifidobacterium breve BR03 (DSM 16604) or Bifidobacterium animalis subspecies lactis BS01 (LMG P-21384), in the management of evacuation disorders and intestinal discomfort. In a period of 5 years (2003 to 2008), the study involved 300 healthy volunteers (151 males and 149 females; age 24 to 71 y) with evacuation disorders and hard stools. In particular, subjects were divided into 3 groups: 80 subjects in the group A received placebo, 110 subjects in the group B received mixed L. plantarum LP01 and B. breve BR03 (2.5 x 10 colony-forming units/d of each strain), and 110 subjects in the group C received B. animalis subsp. lactis BS01 (5 x 10 colony-forming units/d) for 30 days. At the beginning of the observational study, the healthy status of volunteers was evaluated by a complete, laboratory and ultrasound study of the abdomen. The physical examination was repeated after 15 and 30 days. In particular, the main troubles typically associated with evacuation disorders and hard stools as well as abdominal bloating were considered as parameters of interest. Exclusion criteria were items of gastrointestinal diseases and antibiotics intake.
  
  
  RESULTS
  Subjects treated with the mixed probiotic strains L. plantarum LP01 and B. breve BR03 or B. animalis subsp. lactis BS01 reported a significant improvement in the number of weekly bowel movements and in the main troubles associated with evacuations, particularly consistency of feces and ease of expulsion. Discomfort items such as abdominal bloating and anal itching, burning, or pain also registered a relevant improvement in the active groups receiving probiotics.
  
  
  CONCLUSIONS
  The intake of an effective amount of mixed L. plantarum LP01 and B. breve BR03 or B. animalis subsp. lactis BS01 for 30 days is able to significantly relieve the evacuation disorders and hard stools, thus providing a useful tool for the management of such condition, which is particularly widespread in industrialized countries at any age.
authors.affiliation: Gastroenterology Independent Operating Unit, Maggiore della Carità Hospital, Rome, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Del Piano
authors.forename: Stefania
authors.initials: S
authors.lastname: Carmagnola
authors.forename: Andrea
authors.initials: A
authors.lastname: Anderloni
authors.forename: Silvano
authors.initials: S
authors.lastname: Andorno
authors.forename: Marco
authors.initials: M
authors.lastname: Ballarè
authors.forename: Marco
authors.initials: M
authors.lastname: Balzarini
authors.forename: Franco
authors.initials: F
authors.lastname: Montino
authors.forename: Marco
authors.initials: M
authors.lastname: Orsello
authors.forename: Michela
authors.initials: M
authors.lastname: Pagliarulo
authors.forename: Massimo
authors.initials: M
authors.lastname: Sartori
authors.forename: Roberto
authors.initials: R
authors.lastname: Tari
authors.forename: Filomena
authors.initials: F
authors.lastname: Sforza
authors.forename: Lucio
authors.initials: L
authors.lastname: Capurso
mesh_terms: D015746:Abdominal Pain / Q000382:microbiology / Q000628:therapy; D000328:Adult; D000368:Aged; D001644:Bifidobacterium / Q000254:growth & development*; D003248:Constipation / Q000382:microbiology / Q000503:physiopathology / Q000628:therapy*; D003672:Defecation; D004311:Double-Blind Method; D005243:Feces / Q000737:chemistry*; D005260:Female; D005769:Gastrointestinal Motility; D006801:Humans; D007558:Italy; D048191:Lactiplantibacillus plantarum / Q000254:growth & development*; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D019936:Probiotics / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult