P0896 A double-blind, randomized, placebo-controlled, single-center, pilot study evaluating the efficacy of a synbiotic formulation in modulating gut microbiota biodiversity in patients with mild-to-moderate UC in clinical and endoscopic remission
Authors: Murgiano M , Bartocci B , Del Gaudio A , Rozera T , Puca P , Parisio L , Mignini I , Coppola G , De Biasio F , Lavigna D I R , Laterza L , Pugliese D , Papa A , Gasbarrini A , Scaldaferri F , Lopetuso L R 
Published: January 2025

Background

Intestinal dysbiosis is considered a key factor in the pathogenesis and disease progression of Ulcerative Colitis (UC). Probiotics, prebiotics, and synbiotics are promising strategies for microbiota modulation and could play a role as "add-on" therapies to available drugs.

Our primary aim was to characterize the ability of a synbiotic containing Boswellia, Quercetina, Bromelina, Vit. D3, Lactobacillus rhamnosus GG, Inulin, FOS, and Tryptophan in modulating fecal microbiota composition, maintaining disease remission, and controlling the quality of life in patients with Ulcerative Colitis in clinical and endoscopic remission.

Methods

In our double-blind single-center proof-of-concept study, 26 UC patients in clinical and endoscopic remission were enrolled and randomly divided into 2 treatment arms. One group was treated with 5-ASA + placebo and the other with the synbiotic + 5-ASA for a period of 6 months. At baseline and after 6 months disease activity was assessed through the clinical and endoscopic Mayo Score, while quality of life was evaluated through the Psychological General Well-Being Index (PGWBI) and the Gastrointestinal Symptom Rating Scale (GSRS) scores. 16S rRNA gene sequencing was used to analyze gut microbiota composition at both time points.

Results

At microbial analyses, the Mann-Whitney test applied on the Shannon-Weiner, Simpson, and Chao1 indices did not reveal any statistically significant difference after 6 months compared with baseline. Also, the PERMANOVA test applied on the distance matrix calculated with the Bray Curtis and Unweighted Unifrac algorithms did not show statistically significant dissimilarities between the two time points.

At disease evaluation at baseline, overall only 4 patients (15%) had a Full Mayo Score (FMS) of 1, while all the others had FMS = 0. After 6 months of follow-up, 3 patients experienced a flare with an FMS ≥ 2, and 4 patients (21%) had a worsening of the Mayo endoscopic subscore from 0 to 1. In this scenario, no significant differences were registered between the two groups of patients.

At quality of life evaluation, patients treated with the synbiotic experienced a significant improvement in both the psychological/general well-being and gastrointestinal symptoms scores compared with baseline and placebo-treated group. No adverse events were registered.

Conclusion

Our proof-of-concept study shows that the treatment with this synbiotic formulation used in addition to 5-ASA can improve both psychological and gastrointestinal symptoms in patients with UC while maintaining their clinical and endoscopic remission. No direct effects have been observed on gut microbiota modulation. Further investigations are underway to confirm these findings.