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Cited by 31Gastrointestinal motility and disordersProbiotics and Fermented FoodsGut microbiota and health

Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating

Ringel-Kulka, Tamar, McRorie, Johnson, Ringel, Yehuda·2017·American Journal of Gastroenterology
DOI 10.1038/ajg.2016.511
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Abstract

OBJECTIVES: c.f.u. per day) for the relief of abdominal discomfort and bloating in a non-patient population. METHODS: A double-blind, randomized, placebo-controlled, parallel study with a 2-week placebo run-in phase followed by a 4-week intervention phase was conducted at ten clinical centers (USA). Subjects were recruited from the general population by advertisement. The study randomized 302 subjects who experienced abdominal discomfort and bloating ≥2-times per week for at least three months but have not seen a physician or received prescribed medication for their symptoms in the past 12 months. Subjects were assessed for pre- to post-intervention changes in symptom severity (on a 6-point Likert scale; 0=none, 5=very severe) and frequency (symptoms-free days). RESULTS: A total of 275 subjects (mean age 42 years, 79% female, 74% Caucasian) provided evaluable data. Overall mean severity scores at baseline were 2.4 for abdominal discomfort and 2.5 for bloating with no significant differences between the placebo and probiotic groups. Both groups showed significant (P<0.05) improvement in abdominal discomfort and bloating scores over the 4-week intervention period. Mean severity symptom scores at the end of intervention showed no significant differences between the probiotic and the placebo groups in either abdominal discomfort or bloating (P>0.3). The frequency of abdominal bloating-free days was greater in the B. infantis 35624 group compared to the placebo group (P<0.05). Both regimens were well tolerated. CONCLUSIONS: Unlike previous clinical studies in patients with IBS, B. infantis 35624 did not show a significant improvement in the mean severity of symptoms of abdominal discomfort and bloating in a non-patient population. This may be explained by the high placebo effect and the lower impact of functional bowel symptoms in the non-patient population.

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  • An RCT of B. infantis 35624 1×10^9 CFU in 302 individuals with abdominal discomfort or bloating (not IBS) showed significant reduction in discomfort and bloating scores, but not superior to placebo.

    “Another RCT of B . infantis 35624 1 -10 9 colony-forming units conducted in 302 individuals with abdominal discomfort or bloating at a frequency of 2 or more times per week, but who were not patients with a known diagnosis of IBS, demonstrated a signi fi cant reduction in both discomfort and bloating scores after treatment, although this was not superior to placebo. 40”

    From Efficacy of Probiotics in Irritable Bowel Syndrome: Systematic Review and Meta-analysis (2023) · cites this paper as [40]

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Authors
Ringel-Kulka, T., McRorie, J., & Ringel, Y.
Affiliations
  • Procter & Gamble (United States) (US)
  • University of North Carolina at Chapel Hill (US)
Corresponding author
Ringel, Yehuda
Venue
American Journal of Gastroenterology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2017-01
Volume
112
Issue
1
Pages
145-151
ISSN
0002-9270 (ISSN-L)
DOI
10.1038/ajg.2016.511
OpenAlex
W2550234422
Cited by
31
References
18
Citations by year
2026: 4 · 2025: 6 · 2024: 1 · 2023: 3 · 2022: 1 · 2021: 5 · 2020: 5 · 2019: 1 · 2018: 1 · 2017: 4
FWCI
2.18
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (unspecified)
Locations
  • The American Journal of Gastroenterology (publishedVersion)
  • PubMed (publishedVersion)
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, abdominal discomfort, bloating, irritable bowel syndrome, placebo effect, symptom severity
MeSH terms
Bifidobacterium longum subspecies infantis, Adult, Double-Blind Method, Female, Flatulence, Humans, Male, Severity of Illness Index, Abdominal Pain, Treatment Outcome, Probiotics

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