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Clinical Trial
. 2011 Jul;45(6):518-25.
doi: 10.1097/MCG.0b013e31820ca4d6.

Probiotic Bacteria Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis Bi-07 Versus Placebo for the Symptoms of Bloating in Patients With Functional Bowel Disorders: A Double-Blind Study

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Free PMC article
Clinical Trial

Probiotic Bacteria Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis Bi-07 Versus Placebo for the Symptoms of Bloating in Patients With Functional Bowel Disorders: A Double-Blind Study

Tamar Ringel-Kulka et al. J Clin Gastroenterol. .
Free PMC article

Abstract

Background: Recent data suggest a role for the intestinal microbiota in the pathogenesis of functional bowel disorders (FBDs). Probiotic studies in FBDs generated inconsistent results suggesting a strain-specific and product-specific effect.

Aim: To investigate the clinical efficacy of Lactobacillus acidophilus NCFM (L-NCFM) and Bifidobacterium lactis Bi-07 (B-LBi07) in nonconstipation FBDs.

Methods: A double-blind, placebo-control clinical trial of the probiotic bacterias L-NCFM and B-LBi07 twice a day (2×10(11) CFU/d) versus placebo over 8 weeks. Primary endpoints were global relief of gastrointestinal symptoms and satisfaction with treatment. Secondary endpoints were change in symptoms severity, well-being, and quality of life. Microbiological effect was assessed by quantitative real time polymerase chain reaction on fecal samples.

Results: Sixty patients (probiotic, n=31; placebo, n=29), 72% females, 84% whites, mean age 37 years. Abdominal bloating improved in the probiotics compared with the placebo group at 4 weeks (4.10 vs 6.17, P=0.009; change in bloating severity P=0.02) and 8 weeks (4.26 vs 5.84, P=0.06; change in bloating severity P<0.01). Analyses on the irritable bowel syndrome subgroup (n=33) showed similar results.

Conclusions: L-NCFM and B-LBi07 twice a day improve symptoms of bloating in patients with FBDs. These data supports the role of intestinal bacteria in the pathophysiology of FBD and the role for probiotic bacteria in the management of these disorders.

Trial registration: ClinicalTrials.gov NCT00618904.

Figures

Figure 1
Figure 1
Study design
Figure 2
Figure 2
Flowchart of study enrollment, intervention and follow-up Enrolled and entered run-In
Figure 3
Figure 3
Bloating severity at baseline, 4 weeks and 8 weeks of intervention
Figure 4
Figure 4
Change in bloating severity from baseline to 4 weeks and from baseline to 8 weeks of intervention
Figure 5
Figure 5
Concentration of Lactobacillus acidophilus NCFM in fecal samples from subjects pre- and post- intervention
Figure 6
Figure 6
Concentration of Bifidobacterium lactis Bi07 in fecal samples from subjects pre- and post- intervention

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