01
Summary

Lactobacillus acidophilus NCFM was evaluated in a randomized, triple-blind, placebo-controlled trial involving 340 adults with IBS.1 The study assessed the effects of a 1 billion CFU dose and a 10 billion CFU dose of the probiotic over 12 weeks.

Results: The trial found no significant differences between either probiotic dose and placebo in the following areas:

  • Satisfaction with bowel habits
  • Bloating
  • IBS Quality of Life scores (IBS-QoL)
  • IBS symptom severity scores
  • Hospital Anxiety and Depression scores (HADS)

Abdominal Pain Analysis: While there was no overall significant difference in abdominal pain severity between the probiotic and placebo groups, a post hoc analysis of participants with moderate to severe baseline abdominal pain showed a significant reduction in pain sensation with the probiotic treatment, with an effect size of 0.42.

Conclusion: Despite the specific improvement in abdominal pain for some participants, the general lack of superiority of Lactobacillus acidophilus NCFM over placebo at both doses studied suggests that this probiotic is not currently supported for use in IBS treatment. Further research is needed, particularly in individuals with moderate to severe abdominal pain, to explore the potential benefits of this probiotic strain in more severe cases of IBS.

Key Takeaway: Neither a 1 billion CFU nor a 10 billion CFU dose of Lactobacillus acidophilus NCFM has demonstrated superiority over placebo in individuals with IBS.

Recommended Dose: None at this time. Further research is required.

 

 

Reference: 

  1. Lyra A, Hillilä M, Huttunen T, et al. Irritable bowel syndrome symptom severity improves equally with probiotic and placebo. World J Gastroenterol 2016 Dec 28;22(48):10631-10642.[doi:  10.3748/wjg.v22.i48.10631] S 
Read More…

Lactobacillus acidophilus NCFM was evaluated in a randomized, triple-blind, placebo-controlled trial involving 340 adults with IBS.1 The study assessed the effects of a 1 billion CFU dose and a 10 billion CFU dose of the probiotic over 12 weeks.

Results: The trial found no significant differences between either probiotic dose and placebo in the following areas:

  • Satisfaction with bowel habits
  • Bloating
  • IBS Quality of Life scores (IBS-QoL)
  • IBS symptom severity scores
  • Hospital Anxiety and Depression scores (HADS)

Abdominal Pain Analysis: While there was no overall significant difference in abdominal pain severity between the probiotic and placebo groups, a post hoc analysis of participants with moderate to severe baseline abdominal pain showed a significant reduction in pain sensation with the probiotic treatment, with an effect size of 0.42.

Conclusion: Despite the specific improvement in abdominal pain for some participants, the general lack of superiority of Lactobacillus acidophilus NCFM over placebo at both doses studied suggests that this probiotic is not currently supported for use in IBS treatment. Further research is needed, particularly in individuals with moderate to severe abdominal pain, to explore the potential benefits of this probiotic strain in more severe cases of IBS.

Key Takeaway: Neither a 1 billion CFU nor a 10 billion CFU dose of Lactobacillus acidophilus NCFM has demonstrated superiority over placebo in individuals with IBS.

Recommended Dose: None at this time. Further research is required.

 

 

Reference: 

  1. Lyra A, Hillilä M, Huttunen T, et al. Irritable bowel syndrome symptom severity improves equally with probiotic and placebo. World J Gastroenterol 2016 Dec 28;22(48):10631-10642.[doi:  10.3748/wjg.v22.i48.10631] S 
Read More…

Lactobacillus acidophilus NCFM was evaluated in a randomized, triple-blind, placebo-controlled trial involving 340 adults with IBS.1 The study assessed the effects of a 1 billion CFU dose and a 10 billion CFU dose of the probiotic over 12 weeks.

Results: The trial found no significant differences between either probiotic dose and placebo in the following areas:

  • Satisfaction with bowel habits
  • Bloating
  • IBS Quality of Life scores (IBS-QoL)
  • IBS symptom severity scores
  • Hospital Anxiety and Depression scores (HADS)

Abdominal Pain Analysis: While there was no overall significant difference in abdominal pain severity between the probiotic and placebo groups, a post hoc analysis of participants with moderate to severe baseline abdominal pain showed a significant reduction in pain sensation with the probiotic treatment, with an effect size of 0.42.

Conclusion: Despite the specific improvement in abdominal pain for some participants, the general lack of superiority of Lactobacillus acidophilus NCFM over placebo at both doses studied suggests that this probiotic is not currently supported for use in IBS treatment. Further research is needed, particularly in individuals with moderate to severe abdominal pain, to explore the potential benefits of this probiotic strain in more severe cases of IBS.

Key Takeaway: Neither a 1 billion CFU nor a 10 billion CFU dose of Lactobacillus acidophilus NCFM has demonstrated superiority over placebo in individuals with IBS.

Recommended Dose: None at this time. Further research is required.

 

 

Reference: 

  1. Lyra A, Hillilä M, Huttunen T, et al. Irritable bowel syndrome symptom severity improves equally with probiotic and placebo. World J Gastroenterol 2016 Dec 28;22(48):10631-10642.[doi:  10.3748/wjg.v22.i48.10631] S 
02
Results
Overall evidence quality grade
90%

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.

03
Patient Handout
04
Clinical Studies
  • #
  • Study
  • Year
  • Author(s)
  • Journal
  • Reference
  • Daily Dose
  • Duration of Intervention
  • Form
  • Study Design
  • Age
  • Participants
    • Study #1
    • Irritable bowel syndrome symptom severity improves equally with probiotic and placebo

    • 2016
    • Lyra A, Hillilä M, Huttunen T, et al.
    • World J Gastroenterol 2016 Dec 28;22(48):10631-10642

    • DOI: 10.3748/wjg.v22.i48.10631
    • Low dose: 1 billion CFU
      High dose: 10 billion CFU
    • 12 weeks
    • Capsule
      • RANDOMIZED
      • TRIPLE-BLIND
      • PLACEBO-CONTROLLED
      • DOSE-RESPONSE
    • ADULTS

    • ITT,PP (total) n=391,340
      ITT,PP (high dose probiotic) n=131,113
      ITT,PP (low dose probiotic) n=129,112
      ITT,PP (placebo) n=131,115
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
      • Overall, there were no statistically significant differences between the probiotic interventions and the placebo in terms of satisfaction with bowel habits.

    • Global IBS Symptoms
      • Over the 12-week treatment period, IBS-SSS (Irritable Bowel Syndrome Symptom Severity Score) improved across all treatment groups, with decreases of 44.0 ± 80.2 in the placebo group, 50.8 ± 82.4 in the active low-dose group, and 48.3 ± 72.2 in the active high-dose group. Secondary outcomes showed no significant differences between the treatment groups.

      • However, a post hoc analysis of participants with moderate to severe abdominal pain at baseline (VAS > 35/100) revealed a significant reduction in pain sensation. Pain scores decreased by 20.8 ± 22.8 in the placebo group, 29.4 ± 17.9 in the active low-dose group, and 31.2 ± 21.9 in the active high-dose group (P value for placebo vs. combined active doses = 0.0460).

    • Abdominal Pain / Discomfort
      • Overall, there was no statistically significant difference between any of the probiotic interventions and the placebo for abdominal pain severity.

      • However, a post hoc analysis of volunteers with moderate to severe abdominal pain at baseline (VAS > 35/100) found that the treatment significantly reduced the sensation of abdominal pain.

      • Pain scores fell by 20.8 ± 22.8 in the placebo group, 29.4 ± 17.9 in the active low-dose group, and 31.2 ± 21.9 in the active high-dose group (P value for placebo vs. combined active doses = 0.0460).

    • Bloating / Distention
      • Overall, there were no statistically significant differences between the probiotic interventions and the placebo in terms of bloating.

    • Gas / Flatulence
      • No data

    • Nausea / Vomiting
      • No data

    • Mental Health
      • The HADS total score declined significantly from baseline to the end of the intervention in both active treatment groups. HADS anxiety improved significantly across all treatment groups, while HADS depression improved significantly only in the high-dose group.

      • However, none of the between-group comparisons reached statistical significance, although total HADS and HADS anxiety scores were slightly lower in the high-dose group compared to the placebo.

    • Quality of Life
      • The IBS-QoL scores reflected a higher quality of life at the end of the intervention in all treatment groups, although neither active treatment dose was superior to placebo.

    • Miscellaneous Symptoms
      • No data

    • Notes
      • No data