New study results
 

Effects of supplementation of the synbiotic Ecologic®825/FOS P6 on intestinal barrier function in healthy humans: a randomized controlled trial

The intestinal barrier is an essential part of health status and changes in intestinal permeability are thought to precede the development of intestinal diseases.  It is not clear whether increased intestinal permeability is a causal factor or a consequence of intestinal disorders.  A randomized clinical trial investigated the effect of  Ecologic® 825 on intestinal barrier function in healthy volunteers. Supplementation increased stool frequency, but did not affect intestinal permeability. 

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Background

Recently a paper by Wilms et al (1), was published in PLoS ONE, describing the effects of supplementation of the synbiotic combination Ecologic® 825/FOS P6 on intestinal barrier function in healthy volunteers. This was done in a double-blind, placebo-controlled, randomized controlled trial in which twenty healthy volunteers were enrolled. One group received Ecologic® 825 in combination with a fructo-oligosaccharide (FOS), a prebiotic aimed to increase viability and activity of the strains in the gastrointestinal tract, for a period of two weeks. The other group received a placebo. Before and after intervention, both groups were challenged with indomethacin, a non-steroid anti-inflammatory drug (NSAID). Indomethacin is known to cause repairable damage to the mucosal lining of the small intestine (2,3). Small intestinal permeability was assessed by multi-sugar tests as validated by van Wijck et al (4, 5).

Wilms and colleagues found in this study that NSAIDs themselves do have an influence on the gut barrier function, as was measured by this multiple-sugar test. However, the authors found no significant difference between the synbiotic and the placebo group on gut permeability, neither under unstressed nor under NSAID-induced stressed conditions. Two weeks of Ecologic® 825/FOS P6 supplementation did significantly increase stool frequency, although this increase was within a range considered normal. Overall, intake of synbiotic Ecologic® 825/FOS P6 was well tolerated by human subjects in this study. 

New study results Ecologic 825_575

Ecologic® 825 is a multispecies probiotic specifically developed to extend remission time in IBD patients. The  formulations consists of 9 bacterial strains:

 

B. bifidum W23,

B. lactis W51,
B. lactis
W52,

L. acidophilus W22,

L. casei W56,

L. paracasei W20,

L. plantarum W62,

L. salivarius W24,

Lc. lactis W19


with PROBIOACT® Technology; protective and nutritional ingredients that improve the
effectiveness of the product.

   

 

Interpretation

In general, the effects of probiotics on restoring gut barrier function have been well documented (6-9). Studies investigating the multispecies probiotic formulation Ecologic® 825 have demonstrated positive effects on intestinal barrier function, in specific target groups and patient populations (6, 10, 11).

In the study of Wilms et al, performed with a synbiotic combination of Ecologic® 825 and FOS P6, no preventive effects on intestinal barrier function in challenged healthy volunteers were found. As also discussed by the authors there are several arguments that explain the discrepancy between current findings and the results of previous studies.  

 

First of all, this study covered a period of only two weeks, whereas the intervention period for example in an earlier trial with Ecologic® 825 in pouchitis patients lasted 8 weeks. It can be anticipated that in a trial where both the challenge with indomethacin as well as the synbiotic intervention are extended, a positive effect could be noticed. The success of a prolonged intervention was observed by Montalto and colleagues (12) who showed that the use of a multispecies probiotic formulation for three weeks contributed to reduced gastrointestinal damage caused by a NSAIDs challenge for 4 days. The preventive effects of this probiotic intervention were most pronounced after a few days of challenge.  

 

Furthermore, no diaries were kept to follow the participant’s diets and their diets were not controlled. We would assume that differences in dietary patterns would be equally distributed among the two groups due to randomization. As this study was performed with a relative small number of participants, this assumption cannot be made. This is reflected by the fact that in this study the distribution between men and women was significantly different between the synbiotic group (more men) than in the placebo group. A prolonged cross-over study could have overcome these possible biases.  

 

Last but not least, gut barrier function plays an important role in health and disease. However, there are quite some different methods to measure gut barrier function, and the question is whether ‘gut barrier function’ actually can be considered a single mechanism, since it perhaps can be divided in various different mechanisms (13).

  

 

All together, one of the questions is whether one can measure preventive probiotic effects on NSAIDs-induced permeability by using the multiple-sugar-test. A possible explanation for not finding preventive effects of synbiotics in this human volunteer study, could be that NSAIDs and synbiotics work via different routes. However, in this study also no significant differences were found on other markers for gut barrier function, like zonulin or certain immune parameters (TNF-alpha, IL-1b, IL-6, IL-8, IL-17, MCP-1 and MIP-1alpha). These results seem to conflict with previous findings that show that Ecologic® 825 can improve gut barrier function (6,10, 11). Earlier it was found that probiotics, and Ecologic® 825 in specific, did positively affect zonulin and other gut permeability parameters in vivo (6, 10, 11). These positive results were found in studies including specific target and patient groups, like sportsmen and pouchitis patients. 

 
 
Read more about previous publications with Ecologic® 825 on the Winclove website >

   

 

With this, we conclude that the use of a NSAID-challenge model is not a representative model for testing effects of Ecologic® 825/FOS P6 on the permeability in the indications where this formulation for is developed. 

 

 

Ecologic 825 is a b2b formulation. The information in this article should not be used by consumers to diagnose, cure or prevent any diseases.

   

 

Read the scientific publication of the study >

  

 

References

1.         Wilms, E. et al. Effects of Supplementation of the Synbiotic Ecologic(R) 825/FOS P6 on Intestinal Barrier Function in Healthy Humans: A Randomized Controlled Trial. PloS one 11, e0167775 (2016).

2.         Higuchi, K. et al. Present status and strategy of NSAIDs-induced small bowel injury. Journal of gastroenterology 44, 879-888 (2009).

3.         Bjarnason, I., Williams, P., Smethurst, P., Peters, T.J. & Levi, A.J. Effect of non-steroidal anti-inflammatory drugs and prostaglandins on the permeability of the human small intestine. Gut 27, 1292-1297 (1986).

4.         van Wijck, K. et al. Novel multi-sugar assay for site-specific gastrointestinal permeability analysis: a randomized controlled crossover trial. Clinical nutrition (Edinburgh, Scotland) 32, 245-251 (2013).

5.         van Wijck, K., van Eijk, H.M., Buurman, W.A., Dejong, C.H. & Lenaerts, K. Novel analytical approach to a multi-sugar whole gut permeability assay. Journal of chromatography. B, Analytical technologies in the biomedical and life sciences 879, 2794-2801 (2011).

6.         Hemert, S.v., Verwer, J. & Schutz, B. Clinical Studies Evaluating Effects of Probiotics on Parameters of Intestinal Barrier Function. Advances in Microbiology 3, 212-210 (2013).

7.         Hering, N.A., Fromm, M. & Schulzke, J.D. Determinants of colonic barrier function in inflammatory bowel disease and potential therapeutics. The Journal of physiology 590, 1035-1044 (2012).

8.         Isolauri, E. & Salminen, S. Probiotics, gut inflammation and barrier function. Gastroenterology clinics of North America 34, 437-450, viii (2005).

9.         Lamprecht, M. et al. Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial. Journal of the International Society of Sports Nutrition 9, 45 (2012).

10.       Persborn, M. et al. The effects of probiotics on barrier function and mucosal pouch microbiota during maintenance treatment for severe pouchitis in patients with ulcerative colitis. Alimentary pharmacology & therapeutics 38, 772-783 (2013).

11.       Lutgendorff, F., Akkermans, L.M. & Soderholm, J.D. The role of microbiota and probiotics in stress-induced gastro-intestinal damage. Current molecular medicine 8, 282-298 (2008).

12.       Montalto, M. et al. Clinical trial: the effects of a probiotic mixture on non-steroidal anti-inflammatory drug enteropathy - a randomized, double-blind, cross-over, placebo-controlled study. Alimentary pharmacology & therapeutics 32, 209-214 (2010).

13.       Wells, J.M. et al. Homeostasis of the Gut Barrier and Potential Biomarkers. Am J Physiol Gastrointest Liver Physiol, ajpgi 00048 02015 (2016).

  

New study results Ecologic 825

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