Research project led by Bailey Hanna, MS, RDN - no affiliate links, ads or sponsored products.
Summary
This liquid Escherichia coli probiotic preparation was studied in a randomized, placebo-controlled trial in IBS over an 8-week period.1 Initially conducted in 1989 and re-analyzed in 2009, this clinical trial evaluated a range of symptoms, both IBS-related and non-IBS-related.The study set high responder thresholds, requiring the complete absence of an IBS symptom at one or more visits during the treatment period to be considered a responder.
The probiotic group showed significantly more responders compared to placebo for several symptoms, including:
This therapeutic response was apparent from visit 3 onwards which was after around 14 days of supplementation. The probiotic did not significantly outperform the placebo for symptoms such as depression, belching, heartburn, stool frequency, or nighttime pain. A major pitfall in this study was the lack of reported baseline symptom severity and the use of binary yes/no questions to assess therapeutic responses. This approach may have prevented capturing clinically meaningful improvements in participants who did not achieve the responder threshold of complete symptom relief. Overall, our calculated effect sizes were very small, and we’re left with much unknown about the magnitude of the probiotic’s benefits due to the assessment methods. Additionally, a high attrition rate due to incomplete data could have impacted the results. No details about IBS subtypes were provided, though most participants reported “alternating” bowel habits, suggesting a predominant IBS-M population.
Key Takeaway:
One clinical trial has indicated that this E. coli preparation may improve several IBS symptoms. However, aside from measures of complete symptom relief, the extent of symptom improvement remains unknown.
Trial Duration
Reference:
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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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Randomized controlled treatment trial of irritable bowel syndrome with a probiotic E. coli preparation (DSM17252) compared to placebo
Z Gastroenterol 2009; 2009 Feb;47(2):209-14
ADULTS
No data
All data were given as mean +/- standard error of measure (SEM). Responders had to have complete absence of IBS core symptoms at ≥ 1 visit during treatment.
A responder was defined as no longer having IBS symptoms for GSS and APS separately (dichotomous score; i.e., yes/no question regarding the presence of symptoms).
For stool consistency the probiotic produced a mean symptom score improvement on a dichotomous scale of 43%, which was a 15% therapeutic gain over placebo (p=0.001671).
For stool frequency the probiotic produced a mean symptom score improvement of 6% on a dichotomous scale. This was a 3% therapeutic gain over placebo and was not statistically significant.
For complete remission of general IBS symptoms (at least 1 week throughout 8 week treatment duration) The responder rate to the probiotic was 27 /148 (18.2%) in comparison to placebo with 7 /150 (4.67%) (p = 0.000397). NNT=7.4
A responder was defined as no longer having IBS symptoms for GSS and APS separately (dichotomous score; i.e., yes/no question regarding the presence of symptoms). The probiotic achieved a 42% change in symptoms for spontaneous lower abdominal pain from baseline, which was a 16% therapeutic gain over placebo (p=0.013345); for spontaneous diffuse pain, the probiotic produced a 30% improvement in dichotomous symptom scores, which was a 10% therapeutic gain over placebo (p=0.007207).
For pain during palpation of the gallbladder, the probiotic produced a 51% symptom score improvement. This was a 28% therapeutic gain over placebo (p=0.000059).
For spontaneous upper abdominal pain, the probiotic produced a 46% symptom score improvement. This was a 25% therapeutic gain over placebo (p=0.000008).
For pain prior to a meal, the probiotic produced a 46% improvement from baseline. This was a 15% therapeutic gain over placebo (p=0.012330).
For pain after a meal, the probiotic produced a 39% symptom score improvement. This was a 15% therapeutic gain over placebo (p=0.008542).
For pain at night, the probiotic produced a 44% improvement. This was a 13% therapeutic gain over placebo, but was not statistically significant.
For upper abdominal pain with palpation, the probiotic produced a 42% therapeutic improvement. This was a 17% therapeutic gain over placebo (p=0.002156).
Overall 28/148 participants in the probiotic group (18.9%) and 10/150 in the placebo group (6.67%) achieved complete remission of abdominal pain symptoms (p=0.001649) by week 9.
Probiotic NNT= 8.2 for complete remission of abdominal pain symptoms.
For the symptom of bloating there was a mean symptom score improvement on a dichotomous scale of 23%. The therapeutic gain over placebo was 14% which was statistically significant (p=0.000815).
For the symptom of meteorism, there was a mean symptom score improvement on a dichotomous scale of 29%. The therapeutic gain over placebo was 11% which was statistically significant (p=0.0207328)
For the symptom of nausea, there was a 52% mean symptom score improvement on a dichotomous scale. The therapeutic gain over placebo was 10% and was statistically significant (p=0.0334808).
For the symptom of vomiting, there was a 26% mean symptom score improvement on a dichotomous scale. This was a 12% therapeutic gain over placebo (p=0.0092114).
For the symptom of depression, there was a 32% mean symptom score improvement on a dichotomous scale. This was an 8% therapeutic gain over placebo, but was not statistically significant.
For the symptom of “palpable colon” the probiotic produced a 25% mean therapeutic improvement on a dichotomous scale. This was a 21% therapeutic gain over placebo and was statistically significant (p=0.000145).
For bowel sounds, the probiotic produced a 35% change of symptoms on a dichotomous scale. This was a 15% therapeutic gain over placebo and was statistically significant (p=0.0028793).
For the symptom of loss of appetite, there was a 35% mean symptom score improvement on a dichotomous scale. This was a 15% therapeutic gain over placebo, and was statistically significant (p=0.0028793).
For the symptom of headache, there was a 51% therapeutic improvement in the probiotic group. This was a 22% therapeutic gain over placebo and was statistically significant (p=0.0002324).
For the symptom of sleep disturbances, there was a mean therapeutic improvement of 37% in the probiotic group. This was a 17% therapeutic gain over placebo and was statistically significant (p=0.0012882).
For the symptom of belching, there was a 40% mean symptom score improvement on a dichotomous scale. This was a 10% therapeutic gain over placebo, but was not statistically significant.
For the symptom of heartburn, there was a 34% mean symptom score improvement on a dichotomous scale. This was a 3% therapeutic gain over placebo, but was not statistically significant.