Treatment of IBS without constipation with rifaximin compared to a spore -based probiotic

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Dieser Artikel ist Teil unserer Sonderausgabe Mai 2020. Laden Sie die vollständige Ausgabe hier herunter. Bezug Catinean A, Neag AM, Nita A, Buzea M, Buzoianu AD. Bazillus spp. Sporen – eine vielversprechende Behandlungsoption für Patienten mit Reizdarmsyndrom. Nährstoffe. 2019;11(9):1968. Zielsetzung Das Ziel dieser Studie war der Vergleich von Rifaximin, gefolgt von einer nutrazeutischen oder niedrig fermentierbaren Oligosaccharid-, Disaccharid-, Monosaccharid- und Polyoldiät (FODMAP) mit einer alleinigen Therapie mit einem sporenbasierten Probiotikum (MegaSporeBiotic) bei Patienten mit Reizdarmsyndrom ( IBS) ohne Verstopfung. Entwurf Eine nicht verblindete, prospektive, randomisierte, kontrollierte klinische Studie. Die Teilnehmer wurden in 3 Gruppen randomisiert: G1, bei dem die Teilnehmer …
This article is part of our special edition May 2020. Download the full edition here. Related Catineean A, Neag am, Nita A, Buzea M, Buzoianu ad. Bazillus spp. Spores - a promising treatment option for patients with irritable bowel syndrome. Nutrients. 2019; 11 (9): 1968. The aim of this study was to compare rifaximin, followed by a nutritious or low fermentable oligosaccharide, disaccharide, monosaccharide and polyold diet (fodmap) with a sole therapy with a spore-based probiotic (megasporebiotic) in patients with irritable bowel syndrome (IBS) without constipation. Design an unadorned, prospective, randomized, controlled clinical study. The participants were randomized into 3 groups: G1, in which the participants ... (Symbolbild/natur.wiki)

This article is part of our special edition in May 2020. Download the full edition here.

reference

Catineean A, Neag am, Nita A, Buzea M, Buzoianu ad. Bazillus spp. Spores - a promising treatment option for patients with irritable bowel syndrome. nutrients . 2019; 11 (9): 1968.

objective

The goal of this study was the comparison of rifaximin, followed by a nutritious or low fermentable oligosaccharide, disaccharide, monosaccharide and polyold diet (fodmap) with a sole therapy with a spore-based probiotic (megasporebiotic) in patients with irritable bowel syndrome (IBS) without Constipation.

draft

an unadorned, prospective, randomized, controlled clinical study. The participants were randomized in 3 groups:

  • G1, in which the participants received a 10-day cure with rifaximin (1,200 mg), followed by a 24-day cure with a nutritional bifidobacterium Longum w11, soluble fiber and vitamins B 1 b 6 12 .
  • G2, in which the participants received a 34-day course bazillus spp probiotic ( bacillus licheniformis , bacillus indicus hu36 ™, bacillus subtilis hu58 ™, bacillus clausii, bacillus coagulans Megasporbiotic).
  • G3, in which the participants received a 10-day treatment with rifaximin (1,200 mg), followed by a 24-day low-FodMap diet.

The researchers received results measurements at the beginning of the course, day 10 (for groups G1 and G3), day 34 and day 60.

participant

This study comprised 90 patients with irritable bowel syndrome without constipation based on the Rome III criteria. The patients were between 18 and 75 years old and had normal colonoscopy, blood values ​​within the reference values ​​and normal fecal calprotectin in the past 5 years. Patients with documented food allergies, gluten intolerance or celiac disease, diabetes, thyroid diseases, inflammatory bowel diseases or other organic diseases, eating disorders (anorexia or bulimia), probiotics 1 month before the study, antibiotic treatment in the past 6 months or specific diets have been excluded.

study parameters evaluated

The researchers assessed patients based on the IBS-Scheweregrat score (IBS-SS), the quality of life for IBS patients (IBS-QL) and a rectal volume sensation test.

important knowledge

ibs-SS improved at every result measurement for G1, G2 and G3 and, interestingly, improved equally until the end of the study. The Megasporebiotic Group, G2, had an earlier symptom improvement on the 3rd visit (day 34). The quality of life scores and the rectal feeling test also improved in every group, with similar results in every group.

practice implications

irritable bowel syndrome is a common disease that affects around 10 % of the population, with considerable gaps in reliable and inexpensive treatment strategies. 1 Our understanding of pathophysiology quickly extends using systemic biology. The currently proposed model is a complex network of functional disorders of the intestinal microbiota, changed intestinal permeability, changing mobility, gastrointestinal (GI) immune meter activation, visceral hypersensitivity and abnormal intestinal brain interactions. 2 Rifaximin for the first time with the target study as an effective Treatment option to change the GI microbiota, which finally led to FDA approval of rifaximin for the treatment of IBS in 2015. 3 This study should show that non-antibiotic therapy by changing the microbiome by a spore-based probiotic also effective (IBS-D) can.

One of the most exciting aspects of this study is the cost efficiency of spore -based probiotics compared to rifaximin.

This study contains several significant restrictions, many of which recognize the authors. This includes a lack of blinding and placebo, rather moderate than severe symptoms at the start of the study, a lack of breath tests for bacterial overgrowth of the small intestine (SIBO) and the use of ROM III instead of ROM IV criteria. The researchers used ROM III because this study began before Rome IV, and the authors find that 90 % of the participants also met the new criteria.

There are additional restrictions that the authors do not discuss. The first and perhaps most important is that the Rifaximin treatment group was treated both in the dose and in the long term. The currently generally recognized dosage of rifaximin for IBS-D is 550 mg 3 times a day (1,650 mg overall dose) for 14 days. 4 In this study, a total of 1,200 mg per day was used for 10 days, which corresponds to 52 % of the effective dose. This leads to a significant distortion of results compared to the spore -based probiotic intervention.

Improved result measurements could strengthen this study. Initially, the authors used a rectal volume sensation test at the beginning of their studies. This test is invasive, uncomfortable and is hardly supported in the literature as a result of the result for IBS-D. 5 Instead of the rectal sensation of volume, a non-invasive 3-hour lactulose breath would improve the study design. This would have made it possible for the authors to only have patients with SIBO or have responders in every treatment group based on Sibo status. Rezaie et al. found that patients with a positive lactulose breath test for SIBO significantly respond to rifaximin therapy as IBS D patients with a normal breath test. 6 The inclusion of a 3-hour lactulose breath tests in this study would have clarified which patients the best candidates for a spore-based trial treatment in comparison to one Rifaximin therapy.

The use of 2 treatment groups (Rifaximin/Fodmap-poor diet versus spore-based probiotics) or 2 treatment groups and a placebo group would have improved the clarity of the results. Failure could eliminate another source of bias; However, it is impossible to fade therapeutic nutrition towards the usual diet, and this is a constant challenge in nutritional research.

The effects of the therapeutic interventions in this study were buried in confusing and cumbersome tables, so I highlighted positive results in a graphic that illustrated the results of the study. This graphic shows the study results and shows us how effectively these therapies are compared. It also emphasizes the fact that all 3 treatment groups further improved, even after the interventions were canceled at Visite 3 (day 34).

One of the most exciting aspects of this study is the cost efficiency of spore -based probiotics compared to rifaximin. The rifaximin dose used in this study costs approximately $ 1,300, and the recommended dose is 2,000 US dollars. Insurance protection often requires several medication failure and previous permits if the treatment is covered at all. The dose and duration of the spore-based probiotic used in this study costs $ 55 in retail. This represents a significant advantage of spore-based probiotic therapy. The authors did not report on side effects or failures of participants, so it is difficult to calculate these factors in a cost-benefit ratio.

It should also be noted that the results for the spore-based probiotic therapy were similar compared to the treatment group after a low-Fodmap diet. The low-Fodmap diet has turned out to be an effective nutritional strategy for the treatment of IBS-D. 7 Although it is exciting to have an effective nutritional instrument for IBS, this diet is very restrictive and has far-reaching psychosocial and nutritional effects. Low-Fodmap diet compared to other, perhaps even more restrictive diets, a more stressful diet, since the food selection is not intuitive. Patients have to use handouts and apps constantly and must therefore become very vigilant to successfully observe this diet. In this regard, spore -based probiotic therapy offers a significant advantage.

FAZIT

Although this study has several methodological problems that lead to distortions, it is important to recognize that the results of this study improve our understanding of the treatment options for IBS-D. Spore-based probiotic therapy as independent therapy was associated with improvements to the IBS heavy level, the quality of life and the rectal feeling of volume, which corresponded to those of rifaximin therapy followed by a low-FodMap diet or probiotic therapy. The symptoms further improved in all 3 interventions after stopping the treatment, as was demonstrated by improved IBS-heavy scores on day 60 compared to day 34 after the treatment was completed. The most important mistake in the study was the inadequate dose of rifaximin for treatment. Nevertheless, spore -based probiotic therapy offers much simpler treatment to less than 5 % of the cost of rifaximin. Further research is necessary before it can be claimed that spore-based probiotic therapy is just as effective as Rifaximin, but it can certainly be considered when choosing the treatment options for IBS-D patients.

  1. Sperber ad, dumitrascu d, fukudo s, et al. The global prevalence of IBS in adults remains difficult to grasp due to the heterogeneity of the studies: a literature research by the Rome Foundation's work team. intestine . 2017; 66: 1075-1082.
  2. Chey WD, Shah Ed, Dupont Hl. Mechanism of action and therapeutic use of rifaximin in patients with irritable bowel syndrome: a narrative overview. Therapy ADV Gastroenterol . 2020; 13: 1756284819897531.
  3. Pimentel M., Lembo A., Chey Wd, et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. n Engl. J med . 2011; 364 (1): 22-32.
  4. Cangemi DJ, Lacy Be. Treatment of irritable bowel syndrome with diarrhea: a review of non -pharmacological and pharmacological interventions. Therapy ADV Gastroenterol . 2019; 12: 1756284819878950.
  5. Nozu t, Kudaira M. changed rectal sensory reaction, induced by ballotance in patients with functional abdominal pain syndrome. biopsychosoc med . 2009; 3: 13.
  6. Rezaie A, Heimanson Z, McCallum R, Pimentel M. Lactulose A breath tests as a predictor of response to rifaximin in patients with irritable bowel syndrome with diarrhea. Am J Gastroenterol . 2019; 114 (12): 1886-1893.
  7. Zahedi MJ, Behrouz V, Azimi M. Diet with low fermentable oligo-di monosaccharides and polyols compared to general nutritional advice in patients with irritable bowel syndrome with predominant diarrhea: a randomized controlled study. j Gastroenterol Hepatol . 2018; 33 (6): 1192-1199.
  8. Staudacher Hm. Nutritional physiological, microbiological and psychosocial implications of low-Fodmap diet. j Gastroenterol Hepatol . 2017; 32 supplement 1: 16-19.