Reviews on recent clinical trials · 2025
Efficacy of a Preparation based on Symbiotic Association Between Inulin, FOS, L. rhamnosus GG, Bromelin, Boswellia, Vitamin D3, Quercetin and L-tryptophan in Mild-to-Moderate Ulcerative Colitis: A Pilot Retrospective Multicenter Study.
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Mocci Giammarco, Orrù Giorgia, Elisei Walter, Usai Satta Paolo, Onidi Francesca Maria, Tursi Antonio
Аннотация
BACKGROUND AND OBJECTIVES: Several compounds based on short-chain fatty acids and/or probiotics/prebiotics have shown promising results in the therapy of mild-to-moderate ulcerative colitis (UC). The aim of the present study is to investigate the effectiveness of a preparation based on symbiotic association between inulin, fructooligosaccharides (FOS), Lactobacillus rhamnosus GG, bromelin, Boswellia, vitamin D3, quercetin and L-tryptophanon in patients with active mild-to-moderate UC.
MATERIALS: andMethods: This was a multicentre, retrospective, observational cohort study between January 2023 and June 2023. Disease activity was assessed using the partial Mayo score. Patients were assessed at baseline, at 8-week, and 16-week follow-up (FU). The primary endopoint was clinical response, defined as a partial Mayo score reduction of at least 2 points, whereas C-reactive protein (CRP) and fecal calprotectin (FC) reduction at weeks 8 and 16 were secondary endpoints.
RESULTS: Data were collected at baseline from 17 UC patients (M 8, F 9). Median age at diagnosis was 48 years (IQR 20-80), and median disease duration was 10 years (IQR: 2-23). The clinical response at 8 and 16 weeks was observed in 9/17 (52%) and 11/17 (64%) patients, respectively (p =0.697). No difference was observed regarding CRP values, neither at week 8 nor at week 16. Concerning FC levels, we observed a significant decrease from baseline to week 8, from baseline values of 252 (76-359) μg/g to values of 98 (20-448) μg/g at week 8 (p <0.02); no difference was observed from baseline to week 16. Finally, no adverse events were observed during the study period.
CONCLUSION: In this preliminary study, the supplementation with the symbiotic association between inulin, fructooligosaccharides (FOS), Lactobacillus rhamnosus GG, bromelin, Boswellia, vitamin D3, quercetin and L-tryptophanon offers real-world potential in controlling disease activity in patients with mild-to-moderate UC. Further multicentre, placebo-controlled, double-blind clinical trials are needed to validate our results on larger cohorts of patients with UC.
MATERIALS: andMethods: This was a multicentre, retrospective, observational cohort study between January 2023 and June 2023. Disease activity was assessed using the partial Mayo score. Patients were assessed at baseline, at 8-week, and 16-week follow-up (FU). The primary endopoint was clinical response, defined as a partial Mayo score reduction of at least 2 points, whereas C-reactive protein (CRP) and fecal calprotectin (FC) reduction at weeks 8 and 16 were secondary endpoints.
RESULTS: Data were collected at baseline from 17 UC patients (M 8, F 9). Median age at diagnosis was 48 years (IQR 20-80), and median disease duration was 10 years (IQR: 2-23). The clinical response at 8 and 16 weeks was observed in 9/17 (52%) and 11/17 (64%) patients, respectively (p =0.697). No difference was observed regarding CRP values, neither at week 8 nor at week 16. Concerning FC levels, we observed a significant decrease from baseline to week 8, from baseline values of 252 (76-359) μg/g to values of 98 (20-448) μg/g at week 8 (p <0.02); no difference was observed from baseline to week 16. Finally, no adverse events were observed during the study period.
CONCLUSION: In this preliminary study, the supplementation with the symbiotic association between inulin, fructooligosaccharides (FOS), Lactobacillus rhamnosus GG, bromelin, Boswellia, vitamin D3, quercetin and L-tryptophanon offers real-world potential in controlling disease activity in patients with mild-to-moderate UC. Further multicentre, placebo-controlled, double-blind clinical trials are needed to validate our results on larger cohorts of patients with UC.