01
Summary

A pilot trial investigated the effects of Lactobacillus casei rhamnosus LCR35, administered at a dosage of 600 million CFU/day over a 4-week period. The study was a randomized, double-blind, placebo-controlled trial involving individuals with various subtypes of Irritable Bowel Syndrome (IBS) who had moderate IBS symptom severity.

Key Findings

  • Overall Results: There were no statistically significant differences between the probiotic and placebo groups in terms of improvements in IBS severity scores.
  • Anxiety and Depression: Neither group showed clinically relevant changes in Hospital Anxiety and Depression (HAD) scores compared to baseline, with post-treatment scores not provided.
  • Abdominal Pain: Both groups exhibited similar improvements in abdominal pain severity by the end of the treatment period.
  • Quality of Life: No clinically relevant changes in Gastrointestinal Quality of Life Index (GIQLI) scores were observed in either group compared to baseline.

IBS Subtype Analysis

  • IBS-C, IBS-M, and IBS-U: The placebo appeared to result in more pronounced improvements in IBS symptom severity across these subtypes. However, the small sample sizes prevented statistical analysis.
  • IBS-D: The placebo group showed no change in abdominal pain severity scores, whereas the probiotic group experienced a clinically significant decrease in abdominal pain severity (36.6% +/- 44.7%). Again, statistical analysis wasn’t possible due to the small sample size.

Conclusion

This pilot trial evaluating Lactobacillus casei rhamnosus LCR35 for IBS did not show significant improvements in IBS symptoms compared to placebo. The only potential benefit observed was in the IBS-D subtype, where there was a notable reduction in abdominal pain severity. However, due to the small sample sizes, the evidence is insufficient to recommend Lactobacillus casei rhamnosus LCR35 for any IBS subtype.

Key Takeaways

  • No Clear Benefit: The probiotic did not significantly improve overall IBS symptoms compared to placebo.
  • Potential for IBS-D: There may be some benefit for those with IBS-D, particularly in reducing abdominal pain, but more research with larger sample sizes is needed.
  • Further Research Needed: Larger, more comprehensive studies are necessary to determine the potential efficacy of Lactobacillus casei rhamnosus LCR35 for IBS treatment.

Recommended Dose: 

None

 

Reference:

Dapoigny M, Piche T, Ducrotte P, Lunaud B, Cardot JM, Bernalier-Donadille A. Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: a randomized, double-blind study. World J Gastroenterol. 2012 May 7;18(17):2067-75. doi: 10.3748/wjg.v18.i17.2067. PMID: 22563194; PMCID: PMC3342605 S 

Read More…

A pilot trial investigated the effects of Lactobacillus casei rhamnosus LCR35, administered at a dosage of 600 million CFU/day over a 4-week period. The study was a randomized, double-blind, placebo-controlled trial involving individuals with various subtypes of Irritable Bowel Syndrome (IBS) who had moderate IBS symptom severity.

Key Findings

  • Overall Results: There were no statistically significant differences between the probiotic and placebo groups in terms of improvements in IBS severity scores.
  • Anxiety and Depression: Neither group showed clinically relevant changes in Hospital Anxiety and Depression (HAD) scores compared to baseline, with post-treatment scores not provided.
  • Abdominal Pain: Both groups exhibited similar improvements in abdominal pain severity by the end of the treatment period.
  • Quality of Life: No clinically relevant changes in Gastrointestinal Quality of Life Index (GIQLI) scores were observed in either group compared to baseline.

IBS Subtype Analysis

  • IBS-C, IBS-M, and IBS-U: The placebo appeared to result in more pronounced improvements in IBS symptom severity across these subtypes. However, the small sample sizes prevented statistical analysis.
  • IBS-D: The placebo group showed no change in abdominal pain severity scores, whereas the probiotic group experienced a clinically significant decrease in abdominal pain severity (36.6% +/- 44.7%). Again, statistical analysis wasn’t possible due to the small sample size.

Conclusion

This pilot trial evaluating Lactobacillus casei rhamnosus LCR35 for IBS did not show significant improvements in IBS symptoms compared to placebo. The only potential benefit observed was in the IBS-D subtype, where there was a notable reduction in abdominal pain severity. However, due to the small sample sizes, the evidence is insufficient to recommend Lactobacillus casei rhamnosus LCR35 for any IBS subtype.

Key Takeaways

  • No Clear Benefit: The probiotic did not significantly improve overall IBS symptoms compared to placebo.
  • Potential for IBS-D: There may be some benefit for those with IBS-D, particularly in reducing abdominal pain, but more research with larger sample sizes is needed.
  • Further Research Needed: Larger, more comprehensive studies are necessary to determine the potential efficacy of Lactobacillus casei rhamnosus LCR35 for IBS treatment.

Recommended Dose: 

None

 

Reference:

Dapoigny M, Piche T, Ducrotte P, Lunaud B, Cardot JM, Bernalier-Donadille A. Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: a randomized, double-blind study. World J Gastroenterol. 2012 May 7;18(17):2067-75. doi: 10.3748/wjg.v18.i17.2067. PMID: 22563194; PMCID: PMC3342605 S 

Read More…

A pilot trial investigated the effects of Lactobacillus casei rhamnosus LCR35, administered at a dosage of 600 million CFU/day over a 4-week period. The study was a randomized, double-blind, placebo-controlled trial involving individuals with various subtypes of Irritable Bowel Syndrome (IBS) who had moderate IBS symptom severity.

Key Findings

  • Overall Results: There were no statistically significant differences between the probiotic and placebo groups in terms of improvements in IBS severity scores.
  • Anxiety and Depression: Neither group showed clinically relevant changes in Hospital Anxiety and Depression (HAD) scores compared to baseline, with post-treatment scores not provided.
  • Abdominal Pain: Both groups exhibited similar improvements in abdominal pain severity by the end of the treatment period.
  • Quality of Life: No clinically relevant changes in Gastrointestinal Quality of Life Index (GIQLI) scores were observed in either group compared to baseline.

IBS Subtype Analysis

  • IBS-C, IBS-M, and IBS-U: The placebo appeared to result in more pronounced improvements in IBS symptom severity across these subtypes. However, the small sample sizes prevented statistical analysis.
  • IBS-D: The placebo group showed no change in abdominal pain severity scores, whereas the probiotic group experienced a clinically significant decrease in abdominal pain severity (36.6% +/- 44.7%). Again, statistical analysis wasn’t possible due to the small sample size.

Conclusion

This pilot trial evaluating Lactobacillus casei rhamnosus LCR35 for IBS did not show significant improvements in IBS symptoms compared to placebo. The only potential benefit observed was in the IBS-D subtype, where there was a notable reduction in abdominal pain severity. However, due to the small sample sizes, the evidence is insufficient to recommend Lactobacillus casei rhamnosus LCR35 for any IBS subtype.

Key Takeaways

  • No Clear Benefit: The probiotic did not significantly improve overall IBS symptoms compared to placebo.
  • Potential for IBS-D: There may be some benefit for those with IBS-D, particularly in reducing abdominal pain, but more research with larger sample sizes is needed.
  • Further Research Needed: Larger, more comprehensive studies are necessary to determine the potential efficacy of Lactobacillus casei rhamnosus LCR35 for IBS treatment.

Recommended Dose: 

None

 

Reference:

Dapoigny M, Piche T, Ducrotte P, Lunaud B, Cardot JM, Bernalier-Donadille A. Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: a randomized, double-blind study. World J Gastroenterol. 2012 May 7;18(17):2067-75. doi: 10.3748/wjg.v18.i17.2067. PMID: 22563194; PMCID: PMC3342605 S 

02
Results
Overall evidence quality grade
71%

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
    • Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: a randomized, double-blind study

    • 2012
    • Dapoigny M, Piche T, Ducrotte P, Lunaud B, Cardot JM, Bernalier-Donadille A.
    • World J Gastroenterol. 2012 May 7;18(17):2067-75

    • DOI: 10.3748/wjg.v18.i17.2067. PMID: 22563194; PMCID: PMC3342605
    • 600 million CFU
    • 4 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED
      • MULTICENTER
      • PROSPECTIVE
      • TWO PARALLEL GROUPS
    • ADULTS

    • ITT;PP total population n=52;44
      ITT,PP probiotic n=26,21
      ITT,PP placebo n=26,23
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
      • No data

    • Global IBS Symptoms
      • In the overall population, the improvements in the IBS severity score with LCR35 and placebo were not significantly different.

      • At the end of the treatment period, both groups experienced a 25% decrease in severity scores (-63.2 ± 100.6 for LCR35 and -64.3 ± 95.9 for placebo; P = 0.9692).

      • Two weeks post-treatment, both groups maintained a 15% decrease from baseline (-40.6 ± 110.1 for LCR35 and -36.0 ± 109.5 for placebo; P = 0.8829).

    • Abdominal Pain / Discomfort
      • At the end of the treatment period, both the test drug and the placebo showed similar improvements in abdominal pain severity scores. The test drug resulted in a change of -13.1 ± 20.5, while the placebo showed a change of -11.9 ± 27.5.

      • For patients with diarrhea-predominant IBS, the placebo had no effect on the abdominal pain severity score after the 4-week treatment period (-0.1 ± 26.5). In contrast, the test drug led to a significant reduction in pain severity (-18.4 ± 26.3), which translates to a 36.6% ± 44.7% relative change.

      • However, due to the small sample size, no statistical analysis could be performed on these results.

    • Bloating / Distention
      • No data

    • Gas / Flatulence
      • No data

    • Nausea / Vomiting
      • No data

    • Mental Health
      • Participants in the study completed the Hospital Anxiety and Depression (HAD) questionnaire. Throughout the study, there were no clinically significant changes in HAD scores for either the probiotic or placebo groups compared to their baseline measurements.

      • Unfortunately, the study manuscript did not provide additional details regarding the post-treatment scores.

    • Quality of Life
      • Study participants completed a Gastrointestinal Quality of Life Index (GIQLI) questionnaire. The results showed that neither the probiotic group nor the placebo group experienced clinically relevant changes in GIQLI scores compared to their baseline measurements throughout the study.

      • Unfortunately, the study manuscript did not provide any additional details on the post-treatment scores.

    • Miscellaneous Symptoms
      • No data

    • Notes
      • No data