Research project led by Bailey Hanna, MS, RDN - no affiliate links, ads or sponsored products.
One placebo-controlled crossover trial evaluated the effects of this 3-strain probiotic in a combined population of children with IBS or functional dyspepsia. (1) However, we have disqualified this study from our database due to very poor evidence quality.
Although the data collection method seemed valid, the study authors failed to report the results of the scales they used, making it difficult to interpret the findings. Instead, they presented percentages without clarifying what these percentages represented, as the actual scale scores were not disclosed. Additionally, there was selective reporting, with percentages not being provided for all outcome measures. Basic descriptive statistics were missing, and the graphs included in the study were unintelligible. Due to these significant issues, we were unable to include this study in our analysis.
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Evaluate products based on whether they transparently disclose all ingredients and their amounts, exclusively use probiotics tested in randomized placebo-controlled trials in IBS populations, and contain studied doses.
This probiotic has low quality studies in IBS populations supporting it. View our evidence evaluation framework to learn how we assess the quality of studies.
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A Mixture of 3 Bifidobacteria Decreases Abdominal Pain and Improves the Quality of Life in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
J Clin Gastroenterol 2017 Jan;51(1):e5-e10
CHILDREN
In children with IBS , the prevalence of diarrhea before starting treatment was 23% in the probiotic group and 29% in the placebo group. After treatment, resolution of diarrhea was observed in 36% of patients in both the probiotic and placebo groups, with no significant difference between the groups (P = 1).
In patients with IBS, the prevalence of constipation was 21% before starting treatment with the Bifidobacteria mixture and 17% before starting placebo.
After treatment, the proportion of subjects who reported resolution of this symptom was not significantly different between the 2 groups (60% and 37.5% of subjects, respectively, P = 0.6).
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Before starting placebo, 15 of 25 FD patients (60%) and 39 of 48 IBS patients (81%) reported AP, whereas this symptom was present in 12 FD patients (48%) and 44 IBS patients (92%) before starting treatment with the Bifido- bacteria mixture.
By per-protocol analysis, the comparison between the 2 treatment groups showed that AP completely disappeared in a significantly higher proportion of IBS children receiving probiotics (42% vs. 14.5%, P = 0.006), but this finding was not confirmed in FD subjects (20% vs. 36%, P = 0.3).
Findings deriving from intention- to-treat analysis were comparable, with complete AP res- olution occurring in 42% versus 14% of IBS children and in 21% versus 32% of FD subjects after probiotics and placebo, respectively (P = 0.003 and 0.5).
Similarly, in IBS patients, administration of Bifidobacteria mixture significantly improved AP frequency (P = 0.02) when compared with placebo (P = 0.1), whereas this finding was not confirmed in FD subjects (P = 0.06 and 0.09 after probiotics and placebo, respectively).
Pre-placebo median FDI scores were 8 (range, 0 to 40) and 5 (range, 0 to 40) in FD and IBS patients, respectively. Before starting treatment with the Bifidobacteria mixture, median FDI scores were 4 (range, 0 to 35) and 4.5 (range, 0 to 40) in FD and IBS subjects, respectively. Per-protocol analysis showed that the proportion of IBS children who reported an improvement in QoL was significantly higher after probiotics than after placebo (48% vs. 17%, P = 0.002).
Because of the questionable clinical significance of a decrease in FDI from a score of 1 to 0, we repeated the analysis after the exclusion of these patients (n = 3 after probiotics, n = 0 after placebo), and we still found a statistically significant difference (P = 0.006).
Such a finding was confirmed at the intention- to-treat analysis, which showed that an improved QoL was reported by 46% of IBS patients after probiotics versus 16% after placebo (P = 0.002).
In contrast, no difference in the percentages of FD children reporting a significant reduction in FDI score was observed between the treatment and placebo groups (28% vs. 24%, P = 1).