Lactobacillus acidophilus versus placebo in the symptomatic treatment of irritable bowel syndrome: the LAPIBSS randomized trial

Abstract

EudraCT N°2008-A00844-51.

A 2-strain mixture of Lactobacillus acidophilus in the treatment of irritable bowel syndrome: A placebo-controlled randomized clinical trial

“…Although modest, this latter result is consistent with preclinical data demonstrating the strain-specific property of L. acidophilus NCFM to modulate and restore a normal perception of visceral pain [9]. Based on the higher magnitude of positive results observed with L. acidophilus-SDC 2012, 2013 strains, we have suggested an additional benefice of a combined treatment with two strains of the same species without known antagonist effects, and designed a tightly-controlled protocol to test this hypothesis [7,10]. This design was published as L. acidophilus versus placebo in the symptomatic treatment of irritable bowel syndrome (LAPIBSS study) and used to obtain the results of the present RCT [10].…”

“…According to the protocol that we have previously published, we expected a synergistic effect on abdominal pain of 2 strains of the same species without antagonist effects known regarding to positive results of a previous pilot RCT conducted with the 2strain mixture of L. acidophilus SDC-2012, 2013 [7,10]. Modes of action such as strain-specific antinociceptive and immunoregulatory properties have been demonstrated for each strain of L. acidophilus used in our study [9][10][11][12]. Our results do not support this assumption that could be explained by an insufficient dosage and/or duration of the trial.…”

“…In addition, subjects were excluded if they changed their medication in the last 2 months, took probiotics in the last 2 months or antibiotic therapy in the last 30 days, received current antidepressant or antipsychotic treatment, and received antimycotic and antiseptic treatment or treatment affecting gastrointestinal transit as well as chronic use of antalgic and antispasmodic medications. Additional exclusion criteria are detailed in the LAPIBSS protocol [10].…”

“…Based on the higher magnitude of positive results observed with L. acidophilus-SDC 2012, 2013 strains, we have suggested an additional benefice of a combined treatment with two strains of the same species without known antagonist effects, and designed a tightly-controlled protocol to test this hypothesis [7,10]. This design was published as L. acidophilus versus placebo in the symptomatic treatment of irritable bowel syndrome (LAPIBSS study) and used to obtain the results of the present RCT [10]. The use of a second available L. acidophilus strain, i.e.…”

“…helveticus LAFTI L10, was based on preclinical and clinical evidence for its strain-specific gut immune-enhancing properties [11][12][13]. Both strains are also probiotics with approved safety and fermentative properties [8][9][10][11][12][13][14]. The aim of the LAPIBSS study was to test the assumption that the consumption of a 2strain mixture of probiotic L. acidophilus species for 8 weeks could improve abdominal pain/discomfort as primary outcome and the others IBS symptoms such as bloating, flatus, rumbling and bowel habits, including stool frequency and consistency/appearance as secondary outcomes [10].…”