Single Strain

Nissle 1917

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01
Summary

We reviewed two studies on the use of E. coli Nissle 1917 in IBS populations, and unfortunately, neither met the standards for inclusion in our database.

The first study was excluded outright because it failed to report the dosage of the probiotic used (1) — a critical piece of information needed to assess its effectiveness. The second study, though initially evaluated, was ultimately disqualified due to poor evidence quality. (2) 

Here’s why:

  • High Attrition Rate: There was a significant dropout of participants due to protocol deviations, which could significantly bias the results.
  • Selective Reporting: The authors selectively reported data, mentioning effects even though the study actually showed no significant outcomes related to the probiotic.
  • Incomplete Data Reporting: The study failed to report the means and standard deviations for most of the results, leaving a substantial gap in the data needed for accurate analysis.

Given these issues, we have disqualified this probiotic from our database. To truly understand the potential of E. coli Nissle 1917 in managing IBS, future studies need to be well-designed, with rigorous reporting standards and appropriate methodologies.

Key Takeaways: E. coli Nissle 1917 has been disqualified from our database due to insufficient evidence quality. The current evidence is insufficient to recommend the use of this probiotic for IBS.

Dosing Instructions: 

None

 

References:

  1. Faghihi AH, Agah S, Masoudi M, et al. Efficacy of probiotic escherichia coli Nissle 1917 in patients with irritable bowel syndrome: a double blind placebo-controlled randomized trial. Acta Med Indones 2015;47(3):201–8. 

 

  1. Kruis W, Chrubasik S, Boehm S, et al. A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome. Int J Colorectal Dis 2012;27(4):467–74. doi: 10.1007/s00384-011-1363-9. 
Read More…

We reviewed two studies on the use of E. coli Nissle 1917 in IBS populations, and unfortunately, neither met the standards for inclusion in our database.

The first study was excluded outright because it failed to report the dosage of the probiotic used (1) — a critical piece of information needed to assess its effectiveness. The second study, though initially evaluated, was ultimately disqualified due to poor evidence quality. (2) 

Here’s why:

  • High Attrition Rate: There was a significant dropout of participants due to protocol deviations, which could significantly bias the results.
  • Selective Reporting: The authors selectively reported data, mentioning effects even though the study actually showed no significant outcomes related to the probiotic.
  • Incomplete Data Reporting: The study failed to report the means and standard deviations for most of the results, leaving a substantial gap in the data needed for accurate analysis.

Given these issues, we have disqualified this probiotic from our database. To truly understand the potential of E. coli Nissle 1917 in managing IBS, future studies need to be well-designed, with rigorous reporting standards and appropriate methodologies.

Key Takeaways: E. coli Nissle 1917 has been disqualified from our database due to insufficient evidence quality. The current evidence is insufficient to recommend the use of this probiotic for IBS.

Dosing Instructions: 

None

 

References:

  1. Faghihi AH, Agah S, Masoudi M, et al. Efficacy of probiotic escherichia coli Nissle 1917 in patients with irritable bowel syndrome: a double blind placebo-controlled randomized trial. Acta Med Indones 2015;47(3):201–8. 

 

  1. Kruis W, Chrubasik S, Boehm S, et al. A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome. Int J Colorectal Dis 2012;27(4):467–74. doi: 10.1007/s00384-011-1363-9. 
Read More…
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We reviewed two studies on the use of E. coli Nissle 1917 in IBS populations, and unfortunately, neither met the standards for inclusion in our database.

The first study was excluded outright because it failed to report the dosage of the probiotic used (1) — a critical piece of information needed to assess its effectiveness. The second study, though initially evaluated, was ultimately disqualified due to poor evidence quality. (2) 

Here’s why:

  • High Attrition Rate: There was a significant dropout of participants due to protocol deviations, which could significantly bias the results.
  • Selective Reporting: The authors selectively reported data, mentioning effects even though the study actually showed no significant outcomes related to the probiotic.
  • Incomplete Data Reporting: The study failed to report the means and standard deviations for most of the results, leaving a substantial gap in the data needed for accurate analysis.

Given these issues, we have disqualified this probiotic from our database. To truly understand the potential of E. coli Nissle 1917 in managing IBS, future studies need to be well-designed, with rigorous reporting standards and appropriate methodologies.

Key Takeaways: E. coli Nissle 1917 has been disqualified from our database due to insufficient evidence quality. The current evidence is insufficient to recommend the use of this probiotic for IBS.

Dosing Instructions: 

None

 

References:

  1. Faghihi AH, Agah S, Masoudi M, et al. Efficacy of probiotic escherichia coli Nissle 1917 in patients with irritable bowel syndrome: a double blind placebo-controlled randomized trial. Acta Med Indones 2015;47(3):201–8. 

 

  1. Kruis W, Chrubasik S, Boehm S, et al. A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome. Int J Colorectal Dis 2012;27(4):467–74. doi: 10.1007/s00384-011-1363-9. 
02
Results
Overall evidence quality grade
0%

This probiotic has low  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

    • A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome

    • 2012
    • Kruis W, Chrubasik S, Boehm S, et al.

    • Int J Colorectal Dis 2012;27(4):467–74

    • DOI: 10.1007/s00384-011-1363-9
    • 2.5 billion – 25 billion CFU per capsule (2.5-25 x10^9 CFU) 1 capsule x 4 days
      Then 2 capsules/day thereafter for remainder of trial (MUTAFLOR)
    • 12 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PARALLEL-GROUP
      • MONO-CENTER

    • ADULTS

    • ITT,PP (total) n=120,90
      ITT,PP (probiotic) n=60,49
      ITT,PP (placebo) n=60,46
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
  • Subtype Specific Effects
  • Notes

  • Study #1

    • Diarrhea

      • When it comes to urgency, 55.6% of the probiotic group and 50.0% of the placebo group were classified as responders, meaning they reported being either “very much satisfied” or “a little satisfied” according to the IMPSS patient-reported outcome measure. However, this difference between the two groups wasn’t statistically significant (p=0.3208).

      • Additionally, there was no statistically significant improvement within the probiotic group from baseline to the week 12 measurement for urgency (p=0.5316).

    • Constipation

      • In constipation predominant IBS, 57.9% of the probiotic group and 50.0% of the placebo group were classified as responders (meaning they reported being either “very much satisfied” or “little satisfied” on the IMPSS patient reported outcome measure). This between group difference was not statistically significant (p=0.3202)

    • Bowel Habits

      • The study found a statistically significant within-group effect from baseline to the week 12 measurement, suggesting a stool-hardening effect in the probiotic group. Specifically, the mean stool form rating decreased from 1.6 to 1.2 by week 12 (p=0.0023), where stool form was categorized as a deviation from the value 4, which represents a smooth consistency (1 = hard, 7 = watery). The same stool-hardening effect was also observed in the placebo group, which saw a statistically significant reduction from a mean score of 1.6 to 1.2 (p<0.0184).

      • The same stool-hardening effect was also observed in the placebo group, which saw a statistically significant reduction from a mean score of 1.6 to 1.2 (p<0.0184).

      • There was a mean reduction in the number of stools per week in the probiotic group, with a decrease from 15.4 at baseline to 11.9 at week 12, although this difference approached but did not reach statistical significance (p=0.0545). The placebo group also reported a mean reduction in stools per week, from 12.6 at baseline to 10.3 at week 12, and this difference was statistically significant (p=0.0198).

    • Global IBS Symptoms

      • The greatest difference between response rates in comparison to placebo occurred after 10 weeks, with a difference of 20.0% ([2.6; 37.4], p = 0.01), and after 11 weeks of treatment, with an 18.3% difference ([1.0; 35.7], p = 0.02).

      • At the end of the study, the difference between the groups (EcN 53.3%, placebo 41.7%) was 11.6% ([−6.1; 29.4]) and did not reach statistical significance (p = 0.10).

      • After 12 weeks, 27 of the 51 patients (52.9%) achieved clinical response in the EcN group, and 23 of the 48 patients (47.9%) achieved clinical response in the placebo group (PP analysis, p = 0.30).

    • Abdominal Pain / Discomfort

      • For abdominal pain, 54.8% of the probiotic group and 50.0% of the placebo group were classified as responders (meaning they reported being either “very much satisfied” or “little satisfied” on the IMPSS patient reported outcome measure). This between group difference was not statistically significant (p=0.3482).

      • Within group differences in the probiotic group from baseline till the week 12 measurement showed statistically significant improvements in pain intensity, pain duration, and pain frequency (p<0.0001) improving by 19%, 18.1%, and 21.4%, respectively on a 100 point pain scale.

      • Results in the placebo group were on par with these findings with a 16.8%, 15.3%, and 17.5% improvement in symptom scores, respectively. Within group pain results in the placebo group were also statistically significant.

    • Bloating / Distention

      • For meteorism, 58.0% of the probiotic group and 48.2% of the placebo group were classified as responders (meaning they reported being either “very much satisfied” or “little satisfied” on the IMPSS patient reported outcome measure). This between group difference was not statistically significant (p=0.1568)

    • Gas / Flatulence

      • For flatulence, 54.9% of the probiotic group and 44.2% of the placebo group were classified as responders (meaning they reported being either “very much satisfied” or “little satisfied” on the IMPSS patient reported outcome measure). This between group difference was not statistically significant (p=0.1394).

      • Of note, there was a within group statistically significant effect in the probiotic group from baseline until the week 12 measurement for flatulence (p<0.0001). However, a comparable degree of effect was also noted in the placebo group, which also experienced a statistically significant reduction in flatulence severity (p<0.0001).

    • Nausea / Vomiting

      • For nausea, 63.2% of the probiotic group and 50.0% of the placebo group were classified as responders (meaning they reported being either “very much satisfied” or “little satisfied” on the IMPSS patient reported outcome measure). This between group difference was not statistically significant (p=0.2249).

      • Of note, within group differences in the probiotic from baseline till the week 12 measurement found a statistically significant improvement for the symptom of nausea (p=0.0073) with 20% fewer participants reporting “yes” for experiencing nausea.

    • Mental Health

      • No data

    • Quality of Life

      • Health-related quality of life (HRQL) improved in both treatment arms. The baseline score of the probiotic group was 111.6 ± 22.2 and improved by 22.8 ± 28.7 points (20.4%). The respective numbers of the placebo group were 113.8 ± 22.3 (baseline score) and 20.0 ± 29.3 (improvement) (17.6%).

    • Miscellaneous Symptoms

      • The best therapeutic gain of the probiotic was observed in patients with prior bacterial intestinal infection (n = 5) (p = 0.01) as compared to placebo. Another 15 patients were given antibiotics prior to the onset of IBS symptoms. Summing up these patients with an altered enteric microflora (prior antibiotics and/or gastroenteritis; multiple entries possible) (n = 17), the difference in the treatment response between probiotic and placebo was 45.7% (p = 0.029)

    • Subtype Specific Effects

      • IBS-C

         In cases of constipation-predominant IBS, 57.9% of the probiotic group and 50.0% of the placebo group were classified as responders, meaning they reported being either “very much satisfied” or “a little satisfied” according to the IMPSS patient-reported outcome measure. However, the difference between the two groups was not statistically significant (p=0.3202).



      • IBS-D

         In diarrhea-predominant IBS, 51.9% of both the probiotic group and the placebo group were classified as responders, meaning they reported being either “very much satisfied” or “a little satisfied” according to the IMPSS patient-reported outcome measure. There was no difference between the groups, and this lack of difference was reflected in the statistical analysis (p=0.5000).



      • IBS-A

        In IBS participants with alternating stool habits, 61.8% of the probiotic group and 48.6% of the placebo group were classified as responders, meaning they reported being either “very much satisfied” or “a little satisfied” according to the IMPSS patient-reported outcome measure. However, the difference between the two groups was not statistically significant (p=0.1336).



    • Notes

      • This study was disqualified due to poor evidence quality. There was a high attrition rate, with a significant dropout of participants due to protocol deviations, which could significantly bias the results. Additionally, the authors selectively reported data, mentioning effects even though the study actually showed no significant outcomes related to the probiotic. Furthermore, the study failed to report the means and standard deviations for most of the results, leaving a substantial gap in the data needed for accurate analysis.