The use of probiotics in healthy volunteers with evacuation disorders and hard stools: A double-blind, randomized, placebo-controlled study

Mario Del Piano, Stefania Carmagnola, Andrea Anderloni, Silvano Andorno, Marco Ballar̈, Marco Balzarini, Franco Montino, Marco Orsello, Michela Pagliarulo, Massimo Sartori, Roberto Tari, Filomena Sforza, Lucio Capurso

Research output: Contribution to journalArticle

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 71y) 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*109 colony-forming units/d of each strain), and 110 subjects in the group C received B. animalis subsp. lactis BS01 (2.5*109 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.

Original languageEnglish
JournalJournal of Clinical Gastroenterology
Volume44
Issue numberSUPPL. 1
DOIs
Publication statusPublished - Sep 2010

Fingerprint

Lactobacillus plantarum
Probiotics
Healthy Volunteers
Placebos
Developed Countries
Stem Cells
Gastrointestinal Diseases
Pruritus
Dietary Supplements
Feces
Abdomen
Physical Examination
Observational Studies
Anti-Bacterial Agents
Pain
Bifidobacterium animalis
Bifidobacterium breve
Population

Keywords

  • evacuation disorders
  • intestinal discomfort
  • intestinal microbiota
  • intestinal motility
  • probiotic strain

ASJC Scopus subject areas

  • Gastroenterology

Cite this

The use of probiotics in healthy volunteers with evacuation disorders and hard stools : A double-blind, randomized, placebo-controlled study. / Del Piano, Mario; Carmagnola, Stefania; Anderloni, Andrea; Andorno, Silvano; Ballar̈, Marco; Balzarini, Marco; Montino, Franco; Orsello, Marco; Pagliarulo, Michela; Sartori, Massimo; Tari, Roberto; Sforza, Filomena; Capurso, Lucio.

In: Journal of Clinical Gastroenterology, Vol. 44, No. SUPPL. 1, 09.2010.

Research output: Contribution to journalArticle

Del Piano, M, Carmagnola, S, Anderloni, A, Andorno, S, Ballar̈, M, Balzarini, M, Montino, F, Orsello, M, Pagliarulo, M, Sartori, M, Tari, R, Sforza, F & Capurso, L 2010, 'The use of probiotics in healthy volunteers with evacuation disorders and hard stools: A double-blind, randomized, placebo-controlled study', Journal of Clinical Gastroenterology, vol. 44, no. SUPPL. 1. https://doi.org/10.1097/MCG.0b013e3181ee31c3
Del Piano, Mario ; Carmagnola, Stefania ; Anderloni, Andrea ; Andorno, Silvano ; Ballar̈, Marco ; Balzarini, Marco ; Montino, Franco ; Orsello, Marco ; Pagliarulo, Michela ; Sartori, Massimo ; Tari, Roberto ; Sforza, Filomena ; Capurso, Lucio. / The use of probiotics in healthy volunteers with evacuation disorders and hard stools : A double-blind, randomized, placebo-controlled study. In: Journal of Clinical Gastroenterology. 2010 ; Vol. 44, No. SUPPL. 1.
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AU - Del Piano, Mario

AU - Carmagnola, Stefania

AU - Anderloni, Andrea

AU - Andorno, Silvano

AU - Ballar̈, Marco

AU - Balzarini, Marco

AU - Montino, Franco

AU - Orsello, Marco

AU - Pagliarulo, Michela

AU - Sartori, Massimo

AU - Tari, Roberto

AU - Sforza, Filomena

AU - Capurso, Lucio

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N2 - 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 71y) 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*109 colony-forming units/d of each strain), and 110 subjects in the group C received B. animalis subsp. lactis BS01 (2.5*109 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.

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KW - evacuation disorders

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KW - intestinal microbiota

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