Role of Compositum Zeolite® in management of inflammatory bowel disease: a pilot study.

Abstract

Zeolites are crystalline mineral aluminosilicate compounds with microporous structures of tetrahedrons and huge porosity. In the gut, these silicates act as adsorbents, ion-exchangers, catalysts, detergents or antidiarrheic agents. In addition to its well-known antioxidant effect, a new potential advantage of Zeolite could be the microbiome modulation. In this scenery, we aimed to investigate the effect of this compound on inflammation among inflammatory bowel disease patients, assessing both clinical activity and inflammatory markers. This was an open one branch pilot study involving 20 IBD patients, both affected with Crohn's disease and ulcerative colitis affering to San Giovanni Antica Sede Hospital, Città della Salute e della Scienza in Turin. Each patient was given Compositum Zeolite® 6 g/die for 56 days; follow-up time was 60 days from the end of Zeolite therapy. Primary outcomes of the study were to evaluate the improvement of the quality of life (Partial Mayo score or Harvey Bradshaw Index) and the compliance to therapy, while secondary outcome was the reduction of calprotectin value. Of the twenty patients enrolled, 4 did not attend the scheduled check-up visit and 2 reported non-adherence to the therapy with Compositum Zeolite® so these 6 patients were considered as drop out and their data were not included in statistical analysis. So, compliance rate was 70%, that is similar to general adherence to therapy in our setting. Regarding Ulcerative Colitis patients, at the moment of enrolment mean Mayo Partial Score (MPS) was 3.09 (CI: 1.76-4.41) while after 8 weeks of Compositum Zeolite® supplementation the mean MPS was 2.72 (CI: 1.45-4.00) (P=0.57) and after 60 days of follow-up mean MPS was 1.9 (CI: 0.85-2.97) (P=0.24). As Crohn's disease patients are concerned, HBI Score at enrolment was 5.3 (CI: 3.38-7.29) while mean score after 8 week of therapy was 4 (CI: 2.85-5.15) (P=0.042) and after 60 days of follow-up mean score was 3.1 (CI: 1.48-4.87) (P=0.18). Mean calprotectin value at enrolment was 925.64 (CI: 451.83-1399.45). while after 2 months of Compositum Zeolite® addon therapy was 952.72 (CI: 492.73-1412.73); P value 0.93. After 2 months of follow-up mean value was 724.45 (CI: 240.15-1208.73) P value 0.3. Compositum Zeolite® has a compliance rate similar to the other prescribed therapies and is a good addon therapy to improve activity indexes, mainly in Crohn's disease. It also seems to improve inflammatory indexes, even if maybe dose or time of therapy were insufficient to reach a full negativization of these parameters.