01
Summary

Two randomized, double-blind, placebo-controlled trials have evaluated the effects of this 6-strain probiotic blend in IBS populations over the course of 4 weeks. The first study, conducted in 2013 with 49 participants with IBS-D, IBS-C, or IBS-M, found no statistically significant differences between the probiotic and placebo groups in terms of stool frequency and consistency, bloating, or abdominal pain intensity. However, there was a significantly higher response rate in the probiotic group for overall IBS symptom improvement based on a binary yes/no assessment. Our calculated effect size for this parameter suggested a moderate level of improvement compared to the placebo group. Notably, this study had a very small population size and was underpowered.

The second study, conducted in 2015, involved 81 adults with IBS-D, IBS-C, IBS-M, or IBS-U. Although it included more participants, the study was still underpowered. No significant differences were found between the probiotic and placebo groups regarding stool form and frequency, constipation scores, bloating/gas scores, adequate symptom relief, or pain and discomfort. However, the study reported a significant improvement in diarrhea symptoms in the probiotic group compared to the placebo group. The calculated effect size was small, and this result should be interpreted cautiously, given that the probiotic group had significantly higher baseline diarrhea scores than the placebo group. This suggests that the finding for improved diarrhea scores may be due to regression to the mean or the probiotic group simply having more room for improvement. 

Key Takeaways:

The overall evidence for this 6-strain probiotic in IBS is derived from two underpowered studies with largely neutral, untrustworthy, or conflicting results. While dosing information is provided below given the possibility of beneficial effects, we do not consider this blend a first-line probiotic option for IBS based on the current evidence.

Clinicians Notes: 

Potentially Effective Dose 10 Billion CFU/day
Form Capsules, taken as 2 capsules per day
Suggested Minimum 

Trial Duration

4 weeks

 

 

References

  1. Yoon JS, Sohn W, Lee O, et al. Effect of multispecies probiotics on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Gastroenterol Hepatol 2014;29:52–9. doi: 10.1111/jgh.12322.
  2. Yoon H, Park YS, Lee DH, et al. Effect of administering a multi-species probiotic mixture on the changes in fecal microbiota and symptoms of irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Biochem Nutr 2015;57(2):129–34. doi: 10.3164/jcbn.15-14.

 

Read More…

Two randomized, double-blind, placebo-controlled trials have evaluated the effects of this 6-strain probiotic blend in IBS populations over the course of 4 weeks. The first study, conducted in 2013 with 49 participants with IBS-D, IBS-C, or IBS-M, found no statistically significant differences between the probiotic and placebo groups in terms of stool frequency and consistency, bloating, or abdominal pain intensity. However, there was a significantly higher response rate in the probiotic group for overall IBS symptom improvement based on a binary yes/no assessment. Our calculated effect size for this parameter suggested a moderate level of improvement compared to the placebo group. Notably, this study had a very small population size and was underpowered.

The second study, conducted in 2015, involved 81 adults with IBS-D, IBS-C, IBS-M, or IBS-U. Although it included more participants, the study was still underpowered. No significant differences were found between the probiotic and placebo groups regarding stool form and frequency, constipation scores, bloating/gas scores, adequate symptom relief, or pain and discomfort. However, the study reported a significant improvement in diarrhea symptoms in the probiotic group compared to the placebo group. The calculated effect size was small, and this result should be interpreted cautiously, given that the probiotic group had significantly higher baseline diarrhea scores than the placebo group. This suggests that the finding for improved diarrhea scores may be due to regression to the mean or the probiotic group simply having more room for improvement. 

Key Takeaways:

The overall evidence for this 6-strain probiotic in IBS is derived from two underpowered studies with largely neutral, untrustworthy, or conflicting results. While dosing information is provided below given the possibility of beneficial effects, we do not consider this blend a first-line probiotic option for IBS based on the current evidence.

Clinicians Notes: 

Potentially Effective Dose 10 Billion CFU/day
Form Capsules, taken as 2 capsules per day
Suggested Minimum 

Trial Duration

4 weeks

 

 

References

  1. Yoon JS, Sohn W, Lee O, et al. Effect of multispecies probiotics on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Gastroenterol Hepatol 2014;29:52–9. doi: 10.1111/jgh.12322.
  2. Yoon H, Park YS, Lee DH, et al. Effect of administering a multi-species probiotic mixture on the changes in fecal microbiota and symptoms of irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Biochem Nutr 2015;57(2):129–34. doi: 10.3164/jcbn.15-14.

 

Read More…

Two randomized, double-blind, placebo-controlled trials have evaluated the effects of this 6-strain probiotic blend in IBS populations over the course of 4 weeks. The first study, conducted in 2013 with 49 participants with IBS-D, IBS-C, or IBS-M, found no statistically significant differences between the probiotic and placebo groups in terms of stool frequency and consistency, bloating, or abdominal pain intensity. However, there was a significantly higher response rate in the probiotic group for overall IBS symptom improvement based on a binary yes/no assessment. Our calculated effect size for this parameter suggested a moderate level of improvement compared to the placebo group. Notably, this study had a very small population size and was underpowered.

The second study, conducted in 2015, involved 81 adults with IBS-D, IBS-C, IBS-M, or IBS-U. Although it included more participants, the study was still underpowered. No significant differences were found between the probiotic and placebo groups regarding stool form and frequency, constipation scores, bloating/gas scores, adequate symptom relief, or pain and discomfort. However, the study reported a significant improvement in diarrhea symptoms in the probiotic group compared to the placebo group. The calculated effect size was small, and this result should be interpreted cautiously, given that the probiotic group had significantly higher baseline diarrhea scores than the placebo group. This suggests that the finding for improved diarrhea scores may be due to regression to the mean or the probiotic group simply having more room for improvement. 

Key Takeaways:

The overall evidence for this 6-strain probiotic in IBS is derived from two underpowered studies with largely neutral, untrustworthy, or conflicting results. While dosing information is provided below given the possibility of beneficial effects, we do not consider this blend a first-line probiotic option for IBS based on the current evidence.

Clinicians Notes: 

Potentially Effective Dose 10 Billion CFU/day
Form Capsules, taken as 2 capsules per day
Suggested Minimum 

Trial Duration

4 weeks

 

 

References

  1. Yoon JS, Sohn W, Lee O, et al. Effect of multispecies probiotics on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Gastroenterol Hepatol 2014;29:52–9. doi: 10.1111/jgh.12322.
  2. Yoon H, Park YS, Lee DH, et al. Effect of administering a multi-species probiotic mixture on the changes in fecal microbiota and symptoms of irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Biochem Nutr 2015;57(2):129–34. doi: 10.3164/jcbn.15-14.

 

02
Results
Overall evidence quality grade
74%

This probiotic has low to moderate quality studies in IBS populations supporting it. View our evidence evaluation framework to learn how we assess the quality of studies.

03
Patient Handout
04
Clinical Studies
  • #
  • Study
  • Year
  • Author(s)
  • Journal
  • Reference
  • Daily Dose
  • Duration of Intervention
  • Form
  • Study Design
  • Age
  • Participants
    • Study #1
    • Effect of multispecies probiotics on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial

    • 2014
    • Yoon JS, Sohn W, Lee O, et al.
    • J Gastroenterol Hepatol 2014;29:52–9

    • DOI: 10.1111/jgh.12322
    • 10 billion CFU
    • 4 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED
    • ADULTS   19-75 years

    • ITT,PP (total) n=49,49
      ITT,PP (probiotic) n=25.25
      ITT,PP (placebo) n=24,24
    • Study #2
    • Effect of administering a multi-species probiotic mixture on the changes in fecal microbiota and symptoms of irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial

    • 2015
    • Yoon H, Park YS, Lee DH, et al.
    • J Clin Biochem Nutr 2015;57(2):129–34

    • DOI: 10.3164/jcbn.15-14
    • 10 billion CFU
    • 4 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED
    • ADULTS    19-75 years

    • ITT,PP (total) n=95,81
      ITT,PP (probiotic) n=nr,39
      ITT,PP (placebo) n= nr,42
05
Findings from studies

#

  • Diarrhea
  • Constipation
  • Bowel Habits
  • Global IBS Symptoms
  • Abdominal Pain / Discomfort
  • Bloating / Distention
  • Gas / Flatulence
  • Nausea / Vomiting
  • Mental Health
  • Quality of Life
  • Miscellaneous Symptoms
  • Notes
  • Study #1

    • Diarrhea
      • No data

    • Constipation
      • No data

    • Bowel Habits
      • After four weeks, there was no noticeable change in stool frequency or consistency in either the probiotic or placebo group compared to the baseline.

    • Global IBS Symptoms
      • There was a significantly higher response rate in the probiotics group than in the placebo group: 68.0% (17/25) versus 37.5% (9/24) (P = 0.03) in a binary (yes or no) assessment of improvement in overall IBS symptoms. The effect size, as measured by Cohen’s h, was 0.62.

    • Abdominal Pain / Discomfort
      • Relative to baseline, the intensity of abdominal pain (0–10 rating scale) at week 4 was significantly reduced in the probiotics group (3.2 ± 1.7→2.0 ± 1.9, P < 0.01), but not in the placebo group (3.1 ± 1.7→2.6 ± 1.4, P = 0.13).

      • The change of abdominal pain relative to baseline was greater in the probiotics group than the placebo group, but it was not statistically significant (−37.1 ± 46.3% vs −9.2 ± 57.1%, P = 0.07)

    • Bloating / Distention
      • The average percentage change in abdominal bloating (mean ± SD) was −22.4 ± 49.0 for the probiotic group and −20.3 ± 30.5 for the placebo group. The difference between these two groups was not statistically significant (p=0.86).

    • Gas / Flatulence
      • No data

    • Nausea / Vomiting
      • No data

    • Mental Health
      • No data

    • Quality of Life
      • No data

    • Miscellaneous Symptoms
      • No data

    • Notes
      • No data

  • Study #2

    • Diarrhea
      • The repeated-measures analysis of variance revealed a statistically significant difference between the groups (p=0.017; Cohen’s d = 0.49). However, it’s important to note that baseline diarrhea scores were more severe in the probiotic group (5.5 ± 5.3) compared to the placebo group (2.9 ± 4.0; p=0.013). This difference at baseline may have skewed the results in favor of the probiotic group.

    • Constipation
      • Constipation scores significantly decreased over time in both groups, but the repeated-measures analysis of variance showed no statistically significant differences between the groups when comparing these changes (p=0.927).

    • Bowel Habits
      • No time effect was observed for stool form and frequency in either group. The repeated-measures analysis of variance revealed a significant time effect for the total symptom score (p<0.001), indicating that symptoms improved over time. However, the rate of improvement did not significantly differ between the probiotic and placebo groups (p = 0.703).

    • Global IBS Symptoms
      • The proportion of patients reporting adequate symptom relief was higher in the probiotics group (74.4%) compared to the placebo group (61.9%), but this difference was not statistically significant (p = 0.230). Additionally, the decrease in total symptom score over time did not significantly differ between the groups (p = 0.703).

    • Abdominal Pain / Discomfort
      • Pain and discomfort scores significantly decreased over time in both groups. However, the repeated-measures analysis of variance showed no statistically significant differences between the groups when comparing these changes (p=0.409).

    • Bloating / Distention
      • Bloating and gas scores significantly decreased over time in both groups. However, the repeated-measures analysis of variance indicated no statistically significant differences between the groups when comparing these changes (p=0.470).

    • Gas / Flatulence
      • See Distention/ Bloating cell

    • Nausea / Vomiting
      • No data

    • Mental Health
      • No data

    • Quality of Life
      • No data

    • Miscellaneous Symptoms
      • No data

    • Notes
      • No data