Single Strain

UCC4331

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01
Summary

A single randomized, double-blind, placebo-controlled trial investigated the effects of Lactobacillus salivarius UCC4331 in adults with IBS. Participants received the probiotic via a malted milk beverage at a dose of 10 billion CFU/day. However, the quality of evidence from this study was compromised due to several critical shortcomings:

  • The authors failed to report how participants were allocated to different study groups.
  • There were baseline imbalances between the treatment groups, suggesting inadequate randomization.
  • The study was underpowered, meaning it did not include enough participants to detect a meaningful effect.

What Were the Results?

The trial found that L. salivarius UCC4331 did not significantly improve:

  • Bowel movement difficulty scores
  • Stool consistency
  • Bloating
  • Overall composite symptom scores

Interestingly, the only significant benefit was observed in week 2 of the 8-week trial, specifically for abdominal pain. However, this improvement was not sustained throughout the study period.

Key Takeaway

Based on this one clinical trial, L. salivarius UCC4331 does not appear to be superior to a placebo in managing IBS symptoms. Therefore, current evidence does not support recommending L. salivarius UCC4331 for IBS management.

 

Dose:

None

 

References:

O’Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles.Gastroenterol 2005;128(3):541–51.

Read More…

A single randomized, double-blind, placebo-controlled trial investigated the effects of Lactobacillus salivarius UCC4331 in adults with IBS. Participants received the probiotic via a malted milk beverage at a dose of 10 billion CFU/day. However, the quality of evidence from this study was compromised due to several critical shortcomings:

  • The authors failed to report how participants were allocated to different study groups.
  • There were baseline imbalances between the treatment groups, suggesting inadequate randomization.
  • The study was underpowered, meaning it did not include enough participants to detect a meaningful effect.

What Were the Results?

The trial found that L. salivarius UCC4331 did not significantly improve:

  • Bowel movement difficulty scores
  • Stool consistency
  • Bloating
  • Overall composite symptom scores

Interestingly, the only significant benefit was observed in week 2 of the 8-week trial, specifically for abdominal pain. However, this improvement was not sustained throughout the study period.

Key Takeaway

Based on this one clinical trial, L. salivarius UCC4331 does not appear to be superior to a placebo in managing IBS symptoms. Therefore, current evidence does not support recommending L. salivarius UCC4331 for IBS management.

 

Dose:

None

 

References:

O’Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles.Gastroenterol 2005;128(3):541–51.

Read More…
Find a probiotic with UCC4331

There is insufficient evidence demonstrating benefits for IBS with this probiotic. Therefore, we do not provide guidance on finding a commercial product containing this strain/blend.

A single randomized, double-blind, placebo-controlled trial investigated the effects of Lactobacillus salivarius UCC4331 in adults with IBS. Participants received the probiotic via a malted milk beverage at a dose of 10 billion CFU/day. However, the quality of evidence from this study was compromised due to several critical shortcomings:

  • The authors failed to report how participants were allocated to different study groups.
  • There were baseline imbalances between the treatment groups, suggesting inadequate randomization.
  • The study was underpowered, meaning it did not include enough participants to detect a meaningful effect.

What Were the Results?

The trial found that L. salivarius UCC4331 did not significantly improve:

  • Bowel movement difficulty scores
  • Stool consistency
  • Bloating
  • Overall composite symptom scores

Interestingly, the only significant benefit was observed in week 2 of the 8-week trial, specifically for abdominal pain. However, this improvement was not sustained throughout the study period.

Key Takeaway

Based on this one clinical trial, L. salivarius UCC4331 does not appear to be superior to a placebo in managing IBS symptoms. Therefore, current evidence does not support recommending L. salivarius UCC4331 for IBS management.

 

Dose:

None

 

References:

O’Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles.Gastroenterol 2005;128(3):541–51.

02
Results
Overall evidence quality grade
62%

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.

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Patient Handout
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04
Clinical Studies
  • #
  • Study
  • Year
  • Author(s)
  • Journal
  • Reference
  • Daily Dose
  • Duration of Intervention
  • Form
  • Study Design
  • Age
  • Participants
    • Study #1

    • Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles

    • 2005
    • O’Mahony L, McCarthy J, Kelly P, et al.

    • Gastroenterol 2005;128(3):541–51

    • DOI: 10.1053/j.gastro.2004.11.050
    • 10 billion CFU
    • 8 weeks
    • Malted milk drink
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED

    • ADULTS    18-75 years

    • ITT,PP (total) n= 80,67
      ITT,PP (L. salivarius) n=nr,nr
      ITT,PP (B. infantis) n=nr,nr
      ITT,PP (placebo) n=nr,nr
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

      • For bowel movement difficulty scores, there was no significant benefit for those randomized to L salivarius UCC4331. *P < .05 vs placebo. There was no significant improvement in bowel movement consistency

    • Global IBS Symptoms

      • The L. salivarius UCC4331 group experienced no significant reduction in composite scores compared to placebo.

    • Abdominal Pain / Discomfort

      • For those randomized to L salivarius UCC4331, a significant benefit was only evident at week 2 alone. *P < .05 vs placebo for abdominal pain throughout the 8 week trial.

    • Bloating / Distention

      • For bloating, there was no significant benefit for those randomized to L salivarius UCC4331. *P < .05 vs placebo

    • Gas / Flatulence

      • No data

    • Nausea / Vomiting

      • No data

    • Mental Health

      • No data

    • Quality of Life

      • “For most domains, quality-of-life scores were numerically lower than those for placebo for the patients randomized to the probiotics but reached statistical significance versus placebo during the treatment phase only for health worry for bifidobacterium (at the .05 level) and dysphoria for lactobacillus (at the .10 level)”

    • Miscellaneous Symptoms

      • Following treatment with B infantis 35624, PBMC cytokine levels returned to levels similar to those observed for the healthy volunteer group. In contrast, PBMC cytokine levels did not return to levels observed for healthy volunteers in the subjects with IBS who received L salivarius UCC4331 or placebo.

    • Notes

      • No data