01
Summary

Lactobacillus reuteri DSM17938 has been evaluated in one single-blind, placebo-controlled trial involving 92 participants with irritable bowel syndrome (IBS). However, several critical issues were identified in this study, leading to its disqualification from our database: 

  • High Attrition Rate: The dropout rate was 31.7% in the probiotic group and 48.4% in the placebo group.
  • Lack of IBS Subtype Information: The study didn’t specify the IBS subtypes of the participants, making it unclear if the reported increase in “defecation frequency” was beneficial or harmful.
  • Adverse Effects: Statistically significant adverse effects, such as constipation and bloating, were more common in the probiotic group compared to the placebo group.
  • Poor Symptom Monitoring: The study used vague symptom monitoring questionnaires, failing to adequately capture the adverse effects of constipation and bloating.

Key Takeaway

The sole clinical trial available for Lactobacillus reuteri DSM17938 in an IBS population is of exceptionally poor quality, resulting in its disqualification from our database. 

Dose

None

Reference:

Amirimani B, Nikfam S, Albaji M, et al. Probiotic vs. placebo in irritable bowel syndrome: a randomized controlled trial. Middle East J Dig Dis 2013;5(2): 98-102. Probiotic vs. Placebo in Irritable Bowel Syndrome:A Randomized Controlled Trial – PMC (nih.gov) S

Read More…

Lactobacillus reuteri DSM17938 has been evaluated in one single-blind, placebo-controlled trial involving 92 participants with irritable bowel syndrome (IBS). However, several critical issues were identified in this study, leading to its disqualification from our database: 

  • High Attrition Rate: The dropout rate was 31.7% in the probiotic group and 48.4% in the placebo group.
  • Lack of IBS Subtype Information: The study didn’t specify the IBS subtypes of the participants, making it unclear if the reported increase in “defecation frequency” was beneficial or harmful.
  • Adverse Effects: Statistically significant adverse effects, such as constipation and bloating, were more common in the probiotic group compared to the placebo group.
  • Poor Symptom Monitoring: The study used vague symptom monitoring questionnaires, failing to adequately capture the adverse effects of constipation and bloating.

Key Takeaway

The sole clinical trial available for Lactobacillus reuteri DSM17938 in an IBS population is of exceptionally poor quality, resulting in its disqualification from our database. 

Dose

None

Reference:

Amirimani B, Nikfam S, Albaji M, et al. Probiotic vs. placebo in irritable bowel syndrome: a randomized controlled trial. Middle East J Dig Dis 2013;5(2): 98-102. Probiotic vs. Placebo in Irritable Bowel Syndrome:A Randomized Controlled Trial – PMC (nih.gov) S

Read More…

Lactobacillus reuteri DSM17938 has been evaluated in one single-blind, placebo-controlled trial involving 92 participants with irritable bowel syndrome (IBS). However, several critical issues were identified in this study, leading to its disqualification from our database: 

  • High Attrition Rate: The dropout rate was 31.7% in the probiotic group and 48.4% in the placebo group.
  • Lack of IBS Subtype Information: The study didn’t specify the IBS subtypes of the participants, making it unclear if the reported increase in “defecation frequency” was beneficial or harmful.
  • Adverse Effects: Statistically significant adverse effects, such as constipation and bloating, were more common in the probiotic group compared to the placebo group.
  • Poor Symptom Monitoring: The study used vague symptom monitoring questionnaires, failing to adequately capture the adverse effects of constipation and bloating.

Key Takeaway

The sole clinical trial available for Lactobacillus reuteri DSM17938 in an IBS population is of exceptionally poor quality, resulting in its disqualification from our database. 

Dose

None

Reference:

Amirimani B, Nikfam S, Albaji M, et al. Probiotic vs. placebo in irritable bowel syndrome: a randomized controlled trial. Middle East J Dig Dis 2013;5(2): 98-102. Probiotic vs. Placebo in Irritable Bowel Syndrome:A Randomized Controlled Trial – PMC (nih.gov) S

02
Results
Overall evidence quality grade
0%

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
    • Probiotic vs. placebo in irritable bowel syndrome: a randomized controlled trial

    • 2013
    • Amirimani B, Nikfam S, Albaji M, et al.
    • Middle East J Dig Dis 2013;5(2): 98-102

    • PMID: 24829677; PMCID: PMC3990144
    • 100 million CFU
    • 4 weeks
    • Tablet
      • RANDOMIZED
      • PLACEBO-CONTROLLED
      • SINGLE-BLIND
      • PARALLEL GROUP
    • ADULTS

    • Total ITT: n= 36; PP n=30 Probiotic
      ITT/PP: 18;17
      Placebo ITT/PP: 18; 13
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 subtype-specific analysis was conducted in the study. However, the results showed a mean relative symptom score decrease for urgency of 24.6%. The probiotic group had a relative therapeutic gain over the placebo group in decreasing urgency scores by 7.5%, though this difference was not statistically significant (p=0.859).

      • Additionally, two participants (n=2) in the probiotic group experienced diarrhea as an adverse event, compared to none (n=0) in the placebo group, with this difference also not being statistically significant (p=0.503).

    • Constipation
      • In the study, 14.6% (n=6) of participants in the probiotic group experienced constipation as an adverse event, while no participants (n=0) in the placebo group reported this issue. This difference was statistically significant (p=0.033).

    • Bowel Habits
      • In the study, the probiotic group showed a 1% mean relative improvement in evacuation score, while the placebo group had a 4.1% mean relative therapeutic gain. However, the difference between the groups was not statistically significant (p=0.940).

      • Interestingly, the frequency of defecation increased in the Biogaia® group with a relative frequency number score increase of 4%, which was statistically significant from baseline (p=0.048).

      • Despite this improvement, the difference compared to the placebo group was not statistically significant (p=0.091). A notable limitation of the study is that it did not categorize patients based on whether they had diarrhea or constipation.

      • This lack of classification means the overall efficacy of the probiotic remains unclear.

    • Global IBS Symptoms
      • No data

    • Abdominal Pain / Discomfort
      • The study showed a mean relative improvement score for abdominal pain of 24.9% in the probiotic group, while the placebo group had a relative mean therapeutic gain over the probiotic of 8.6%. This difference was not statistically significant (p=0.311).

      • Additionally, 7.3% (n=3) of participants in the probiotic group experienced abdominal pain as an adverse event, which was not statistically significant compared to the placebo group (p=1.00).

      • One participant in the probiotic group reported an adverse event of anal pain, but this was also not statistically significant compared to the placebo group (p=1.00).

    • Bloating / Distention
      • The study reported a mean relative improvement score for bloating of 16.4% in the probiotic group. Interestingly, the placebo group showed a relative mean therapeutic gain over the probiotic group of 6.9%.

      • However, this difference was not statistically significant (p=0.657). On the other hand, 14.6% (n=6) of participants in the probiotic group experienced bloating as an adverse event, compared to none (n=0) in the placebo group. This was a statistically significant effect (p=0.033).

    • Gas / Flatulence
      • No data

    • Nausea / Vomiting
      • One participant (2.4%) in the probiotic group experienced nausea as an adverse event. This was not statistically significant when compared to the placebo group (p=1.00).

    • Mental Health
      • No data

    • Quality of Life
      • No data

    • Miscellaneous Symptoms
      • In the probiotic group, two participants experienced heartburn, one experienced epigastric burning, and one experienced epigastric fullness. These results were not statistically significant compared to the placebo group (p > 0.05).

      • Additional adverse events reported in the probiotic group included dark green stool (n=1), bad oral taste (n=1), headaches (n=1), belching (n=2), and skin rash (n=1). None of these adverse events were statistically significant compared to the placebo group (p > 0.05).

    • Notes
      • No data