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Safety of Bifidobacterium breve, Bif195, employing a human exercise-induced intestinal permeability model: a randomised, double-blinded, placebo-controlled, parallel group trial
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We have previously shown that the probiotic Bifidobacterium breve strain Bif195 alleviates mucosal injury including ulcer formation in the upper intestine induced by non-steroid anti-inflammatory drugs (NSAIDs). Here, we report additional safety use of Bif195 in 126 healthy humans undergoing an exercise-induced intestinal permeability challenge in a double-blinded, placebo-controlled randomised 6-week intervention trial. Intestinal permeability was assessed by urinary lactulose/rhamnose (L/R) ratio. L/R ratio, plasma intestinal fatty acid binding protein (I-FABP) and gastrointestinal symptom rating scale (GSRS) questionnaire were measured resting and after a 1 h treadmill challenge, prior to and at the end of the intervention. To be able to compare the equivalence of resting state at baseline, of this cohort of well-trained subjects, to non-trained subjects, a cohort of 63 healthy and non-trained subjects (<2 h/week of endurance sports) was included. Study subjects (well-trained) were 35.7% women with a mean age and body mass index (in kg/m2) of 35.0 years and 24.8, respectively. There were no differences between the Bif195 and placebo groups in effects on L/R ratio, I-FABP and GSRS questionnaire score. In addition, there were no differences between Bif195 and placebo in number of adverse events and change in cytokines, liver or kidney biomarkers. The exercise model successfully induced intestinal permeability by statistically significantly increasing L/R ratio by ~100% (P<0.0001) and cytokines after the exercise challenge. No significant difference was found between well-trained and non-trained subjects in baseline resting L/R ratio. In conclusion, the reported cytoprotective effects of Bif195 are unlikely to be primarily related to small bowel permeability, and the safety of Bif195 in individuals with increased permeability is supported by the present data.
ClinicalTrials.gov: NCT03027583
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Bjarnason, I., Scarpignato, C., Holmgren, E., Olszewski, M., Rainsford, K.D. and Lanas, A., 2018. Mechanisms of damage to the gastrointestinal tract from nonsteroidal anti-inflammatory drugs. Gastroenterology 154: 500-514. https://doi.org/10.1053/j.gastro.2017.10.049
-
Boyle, R.J., Robins-Browne, R.M. and Tang, M.L., 2006. Probiotic use in clinical practice: what are the risks? American Journal of Clinical Nutrition 83: 1256-1264. https://doi.org/10.1093/ajcn/83.6.1256
-
Chantler, S., Griffiths, A., Matu, J., Davison, G., Jones, B. and Deighton, K., 2021. The effects of exercise on indirect markers of gut damage and permeability: a systematic review and meta-analysis. Sports Medicine 51: 113-124. https://doi.org/10.1007/s40279-020-01348-y
-
Costa, R.J.S., Snipe, R.M.J., Kitic, C.M. and Gibson, P.R., 2017. Systematic review: exercise-induced gastrointestinal syndrome – implications for health and intestinal disease. Alimentary Pharmacology and Therapeutics 46: 246-265. https://doi.org/10.1111/apt.14157
-
De Oliveira, E.P. and Burini, R.C., 2009. The impact of physical exercise on the gastrointestinal tract. Current Opinion in Clinical Nutrition and Metabolic Care 12: 533-538. https://doi.org/10.1097/MCO.0b013e32832e6776
-
Keirns, B.H., Koemel, N.A., Sciarrillo, C.M., Anderson, K.L. and Emerson, S.R., 2020. Mini-review: exercise and intestinal permeability: another form of exercise-induced hormesis? American Journal of Physiology – Gastrointestinal and Liver Physiology 319: G512-G518. https://doi.org/10.1152/ajpgi.00232.2020.-Regular
-
Koutsoumanis, K., Allende, A., Alvarez-Ordóñez, A., Bolton, D., Bover-Cid, S., Chemaly, M., Davies, R., De Cesare, A., Hilbert, F., Lindqvist, R., Nauta, M., Peixe, L., Ru, G., Simmons, M., Skandamis, P., Suffredini, E., Cocconcelli, P.S., Fernández Escámez, P.S., Maradona, M.P., Querol, A., Suarez, J.E., Sundh, I., Vlak, J., Barizzone, F., Hempen, M. and Herman, L., 2020. Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020. EFSA Journal 18: e06174. https://doi.org/10.2903/j.efsa.2020.6174
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Mortensen, B., Murphy, C., O’Grady, J., Lucey, M., Elsafi, G., Barry, L., Westphal, V., Wellejus, A., Lukjancenko, O., Eklund, A.C., Nielsen, H.B., Baker, A., Damholt, A., van Hylckama Vlieg, J.E.T., Shanahan, F. and Buckley, M., 2019. Bifidobacterium breve Bif195 Protects Against Small-Intestinal Damage Caused By Acetylsalicylic Acid In Healthy Volunteers. Gastroenterology 157: 637-646.e4. https://doi.org/10.1053/j.gastro.2019.05.008
-
Pals, K.L., Chang, R.T., Ryan, A.J. and Gisolfi, C. V., 1997. Effect of running intensity on intestinal permeability. Journal of Applied Physiology 82: 571-576. https://doi.org/10.1152/jappl.1997.82.2.571
-
Pariza, M.W., Gillies, K.O., Kraak-Ripple, S.F., Leyer, G. and Smith, A.B., 2015. Determining the safety of microbial cultures for consumption by humans and animals. Regulatory Toxicology and Pharmacology, 73: 164-171. https://doi.org/10.1016/j.yrtph.2015.07.003
-
Pasini, E., Corsetti, G., Assanelli, D., Testa, C., Romano, C., Dioguardi, F.S. and Aquilani, R., 2019. Effects of chronic exercise on gut microbiota and intestinal barrier in human with type 2 diabetes. Minerva Medica 110: 3-11. https://doi.org/10.23736/S0026-4806.18.05589-1
-
Ribeiro, F.M., Petriz, B., Marques, G., Kamilla, L.H. and Franco, O.L., 2021. Is there an exercise-intensity threshold capable of avoiding the leaky gut? Frontiers in Nutrition 8: 627289. https://doi.org/10.3389/fnut.2021.627289
-
Svedlund, J., Sjodin, I. and Dotevall, G., 1988. GSRS – a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Digestive Diseases and Sciences 33: 129-134. https://doi.org/10.1007/BF01535722
-
Van Nieuwenhoven, M.A., Brouns, F. and Brummer, R.J.M., 2004. Gastrointestinal profile of symptomatic athletes at rest and during physical exercise. European Journal of Applied Physiology 91: 429-434. https://doi.org/10.1007/S00421-003-1007-Z
-
Van Wijck, K., Lenaerts, K., Van Bijnen, A.A., Boonen, B., Van Loon, L.J.C., Dejong, C.H.C. and Buurman, W.A., 2012. Aggravation of exercise-induced intestinal injury by ibuprofen in athletes. Medicine and Science in Sports and Exercise 44: 2257-2262. https://doi.org/10.1249/MSS.0b013e318265dd3d
-
Zuhl, M., Schneider, S., Lanphere, K., Conn, C., Dokladny, K. and Moseley, P., 2014. Exercise regulation of intestinal tight junction proteins. British Journal of Sports Medicine 48: 980-986. https://doi.org/10.1136/bjsports-2012-091585.
Supplementary Materials
| Insgesamt | Letzte 365 Tage | In den letzten 30 Tagen | |
|---|---|---|---|
| Aufrufe von Kurzbeschreibungen | 0 | 0 | 0 |
| Gesamttextansichten | 1049 | 438 | 54 |
| PDF-Downloads | 1210 | 537 | 61 |
Safety of Bifidobacterium breve, Bif195, employing a human exercise-induced intestinal permeability model: a randomised, double-blinded, placebo-controlled, parallel group trial
in Beneficial MicrobesSearch for other papers by S. Engel in
Current site
Google Scholar
PubMed
Search for other papers by B. Mortensen in
Current site
Google Scholar
PubMed
Search for other papers by A. Wellejus in
Current site
Google Scholar
PubMed
Search for other papers by N. Vera-Jimenez in
Current site
Google Scholar
PubMed
Search for other papers by C. Struve in
Current site
Google Scholar
PubMed
Search for other papers by R.J. Brummer in
Current site
Google Scholar
PubMed
Search for other papers by A. Damholt in
Current site
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PubMed
Search for other papers by T. Woods in
Current site
Google Scholar
PubMed
Search for other papers by F. Shanahan in
Current site
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PubMed
We have previously shown that the probiotic Bifidobacterium breve strain Bif195 alleviates mucosal injury including ulcer formation in the upper intestine induced by non-steroid anti-inflammatory drugs (NSAIDs). Here, we report additional safety use of Bif195 in 126 healthy humans undergoing an exercise-induced intestinal permeability challenge in a double-blinded, placebo-controlled randomised 6-week intervention trial. Intestinal permeability was assessed by urinary lactulose/rhamnose (L/R) ratio. L/R ratio, plasma intestinal fatty acid binding protein (I-FABP) and gastrointestinal symptom rating scale (GSRS) questionnaire were measured resting and after a 1 h treadmill challenge, prior to and at the end of the intervention. To be able to compare the equivalence of resting state at baseline, of this cohort of well-trained subjects, to non-trained subjects, a cohort of 63 healthy and non-trained subjects (<2 h/week of endurance sports) was included. Study subjects (well-trained) were 35.7% women with a mean age and body mass index (in kg/m2) of 35.0 years and 24.8, respectively. There were no differences between the Bif195 and placebo groups in effects on L/R ratio, I-FABP and GSRS questionnaire score. In addition, there were no differences between Bif195 and placebo in number of adverse events and change in cytokines, liver or kidney biomarkers. The exercise model successfully induced intestinal permeability by statistically significantly increasing L/R ratio by ~100% (P<0.0001) and cytokines after the exercise challenge. No significant difference was found between well-trained and non-trained subjects in baseline resting L/R ratio. In conclusion, the reported cytoprotective effects of Bif195 are unlikely to be primarily related to small bowel permeability, and the safety of Bif195 in individuals with increased permeability is supported by the present data.
ClinicalTrials.gov: NCT03027583
| Insgesamt | Letzte 365 Tage | In den letzten 30 Tagen | |
|---|---|---|---|
| Aufrufe von Kurzbeschreibungen | 0 | 0 | 0 |
| Gesamttextansichten | 1049 | 438 | 54 |
| PDF-Downloads | 1210 | 537 | 61 |
