Research project led by Bailey Hanna, MS, RDN - no affiliate links, ads or sponsored products.
This 11-strain probiotic blend has been put to the test in a double-blind, placebo-controlled trial involving 101 women with IBS-D (Irritable Bowel Syndrome with Diarrhea).(1) While both the probiotic and placebo groups reported significant improvements in individual symptoms, there was no notable difference between the two groups.
Study Findings:
Key Takeaway:
Based on these findings, this 11-strain probiotic blend does not show greater therapeutic benefits than a placebo in managing IBS-D symptoms in women. Therefore, its use for IBS is not recommended at this time.
Recommended Dosing:
None
Reference:
There is insufficient evidence demonstrating benefits for IBS with this probiotic. Therefore, we do not provide guidance on finding a commercial product containing this blend.
This probiotic has higher 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 double-blind, placebo-controlled study to assess the effect of a probiotic mixture on symptoms and inflammatory markers in women with diarrhea-predominant IBS
Neurogastroenterol Motil 2017 Jul;29(7)
WOMEN 18-70 years
There were no significant differences in stool consistency between the BIO-25 group and the placebo group (42.6% vs 34.0%, P=.423). Interestingly, the placebo group seemed to show a greater improvement in urgency scores, with a 37.9% +/- 33.9% improvement compared to 25.5% +/- 35.4% in the probiotic group, although this difference was not statistically significant (p=.071).
No data
In the study, there were no significant differences between the BIO-25 group and the placebo group in terms of stool consistency, with 42.6% and 34.0% respectively (P=.423). Similarly, the mean symptom score improvement showed no statistically significant difference for frequency score (P=0.913) or the number of bowel movements per day (P=0.536).
There was no significant difference in overall responder rates between the BIO-25 group and the placebo group, with rates of 20.4% and 24.0%, respectively (P = .814). To be considered a “responder,” a patient had to show improvement in both pain intensity and stool consistency.
There were no significant differences between the BIO-25 group and the placebo group in terms of pain intensity, with rates of 27.8% and 46.0%, respectively (P = .068). However, when the change in individual symptoms was adjusted for the time of the study period (days), the placebo group showed a significantly higher magnitude of improvement in abdominal pain (the primary endpoint) and bloating compared to the BIO-25 group (P = .000 and P = .019, respectively).
When the change in individual symptoms was adjusted over the study period (in days), the placebo group showed a significantly greater improvement in both abdominal pain and bloating compared to the BIO-25 group. Specifically, the differences were highly significant with a P-value of .000 for abdominal pain and .019 for bloating.
No significant changes were observed within each group when comparing fecal calprotectin levels from baseline to week 8. For the BIO-25 group, levels changed from 16.50 (8.0-31.25) μg/g at baseline to 12.0 (7.0-25.75) μg/g at week 8 (P = .935). In the placebo group, levels changed from 21.0 (9.5-49.0) μg/g at baseline to 23.0 (12.0-74.0) μg/g at week 8 (P = .817).
Similarly, high sensitivity C-reactive protein (CRP) levels did not change significantly in either group at week 8 compared to baseline. In the BIO-25 group, CRP levels were 1.20 (0.56-3.53) mg/L at baseline and 1.39 (0.39-2.66) mg/L at week 8 (P = .225). In the placebo group, CRP levels were 1.20 (0.47-2.74) mg/L at baseline and 1.48 (0.59-2.86) mg/L at week 8 (P = .177).