A double-blind, randomized, placebo-controlled, single-center, pilot study evaluating the role of a L. rhamnosus GG-based symbiotic formulation in patients with mild-to-moderate uc in clinical and endoscopic remission

Objective: Intestinal dysbiosis is considered a key factor in the pathogenesis and disease progression of ulcerative colitis. Probiotics, prebiotics, and symbiotics are promising strategies for microbiota modulation and could play a role as “add-on” therapies to available drugs. The aim of the study was to characterize the ability of a synbiotic containing Boswellia, Quercetina, Bromelina, Vit. D3, Lactobacillus Rhamnosus GG, Inulin, FOS, and Tryptophan in modulating microbiota composition, in maintaining disease remission, and in controlling the quality of life in patients with Ulcerative Colitis (UC) in clinical and endoscopic remission. Patients and Methods: In our randomized double-blind, placebo-controlled, single-center proof-of-concept study, 26 UC patients in clinical and endoscopic remission were enrolled. One group was treated with 5-ASA + placebo, and one with the synbiotic + 5-ASA for a period of 6 months. Disease activity was assessed through the clinical and endoscopic Mayo Scores, while quality of life was evaluated using the Psychological General Well-being Index and the Gastrointestinal Symptom Rating Scale scores. 16S rRNA microbial gene sequencing was used. Results: At the microbial analyses, the Mann-Whitney test applied to the Shannon-Wiener, Simpson, and Chao1 indices did not reveal any statistically significant differences after 6 months compared with the baseline. The PERMANOVA test did not show statistically significant dissimilarities between the two time points. At clinical and endoscopic disease evaluation at baseline and after 6 months, no significant differences were registered between the two groups. 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 the placebo-treated group. Conclusions: Our proof-of-concept study demonstrates that treatment with the synbiotic formulation, in addition to 5-ASA, is effective in improving both psychological and gastrointestinal symptoms in patients with UC, while maintaining their clinical and endoscopic remission. Further investigations are underway to confirm these findings.