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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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.
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Other probiotic studies in healthy subjects with minor digestive symptoms have mainly focused on GI well-being and symptoms with mixed results.
“Other probiotic studies in healthy subjects with minor digestive symptoms have mainly focused on GI well-being and symptoms with mixed results( 25 , 26 , 39 ).”
From Effect of the probiotic strain <i>Bifidobacterium animalis</i> subsp. <i>lactis</i> , BB-12 <sup>®</sup> , on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial (2015) · cites this paper as [39]
The Methods (Study population) describe participants with diagnosed functional bowel disorders and active symptoms, not healthy subjects with minor digestive symptoms. The Methods (Assessment for clinical effect) and Results (Clinical Effects) show that the study assessed GI symptoms and well-being and found mixed outcomes: bloating improved, but global symptom relief and well-being did not differ from placebo. The cited study therefore supports the outcomes and mixed-results portion, but not the claimed population. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOther smaller studies reported some beneficial effects with other probiotic strains including Bifidobacterium animalis DN-173 010, Bifidobacterium bifidum MIMBb75, Lactobacillus plantarum 299V, Saccharomyces boulardii, combination of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07, and multispecies probiotic mixtures.
“Other smaller studies reported some beneficial effects with other probiotic strains including Bifidobacterium animalis DN-173 010 (74), Bifidobacterium bifidum MIMBb75 (72), Lactobacillus plantarum 299V (117), Saccharomyces boulardii (37), and combination of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 (144) and multispecies probiotic mixtures (71, 87, 88).”
From Intestinal microbiota and immune function in the pathogenesis of irritable bowel syndrome (2013) · cites this paper as [144]
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“digestive symptoms have mainly focused on GI well-being and symptoms with mixed results((25,26,39)).”
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- Authors
- Ringel-Kulka, T., Palsson, O. S., Maier, D., Carroll, I., Galanko, J. A., Leyer, G., & Ringel, Y.
- Corresponding author
- Palsson, Olafur S.
- Maier, Danielle
- Carroll, Ian
- Galanko, Joseph A.
- Ringel, Yehuda
- Venue
- Journal of Clinical Gastroenterology
- Published
- 2011-07
- Volume
- 45
- Issue
- 6
- Pages
- 518-525
- ISSN
- 0192-0790 (ISSN-L)
- PMC
- PMC4372813
- OpenAlex
- W2009129153
- Cited by
- 174
- References
- 36
- Citations by year
- 2026: 5 · 2025: 7 · 2024: 15 · 2023: 15 · 2022: 12 · 2021: 13 · 2020: 8 · 2019: 10 · 2018: 13 · 2017: 10 · 2016: 10 · 2015: 10 · 2014: 13 · 2013: 14 · 2012: 16
- FWCI
- 15.10
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (K23DK075621, DK 034987, P30DK034987)
- National Center for Research Resources (RR00046, M01RR000046)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- probiotics, Lactobacillus acidophilus NCFM, bloating, functional bowel disorders, irritable bowel syndrome, gut microbiota, gastrointestinal symptoms, quality of life, fecal microbiota
- MeSH terms
- Adult, Bifidobacterium, Double-Blind Method, Feces, Female, Flatulence, Humans, Intestines, Lactobacillus acidophilus, Male, Middle Aged, Placebos, Treatment Outcome, Probiotics, Irritable Bowel Syndrome
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