Fenix Pharma presented at the FISMAD congress, held in Rome from May 11 to 14, 2022, the significant results achieved with ENTEROFLEGIN in patients with symptomatic uncomplicated diverticular disease (SUDD). These findings were published in the study “Performance of a multicompound nutraceutical formulation in patients with symptomatic uncomplicated diverticular disease” (Brandimarte et al., 2022, Minerva Medica).

ENTEROFLEGIN, developed through Fenix Pharma's research, is an innovative nutraceutical with PREBIOTIC and ANTI-INFLAMMATORY activity. It is composed of HBQ COMPLEX (a patented complex consisting of the medicinal mushroom Hericium erinaceus, quercetin, and berberine) along with niacin and biotin.

BACKGROUND AND PURPOSE

Symptomatic uncomplicated diverticular disease (SUDD) is a recognized clinical condition characterized by abdominal pain and changes in bowel habits, attributed to diverticula but without macroscopic signs of diverticulitis. There is no consensus on the management of patients with SUDD. A retrospective observational study was conducted to evaluate the efficacy and safety of the nutraceutical ENTEROFLEGIN® for the treatment of patients with SUDD.

MATERIALS AND METHODS

Patients were treated with 2 tablets/day of ENTEROFLEGIN® for 10 days per month over a period of 6 months. The primary endpoint was the clinical remission rate, defined as the absence of symptoms. Secondary endpoints included the treatment's impact on symptom reduction, fecal calprotectin (FC) levels, and the prevention of acute diverticulitis.

Result

Data from 350 patients were retrospectively collected across 19 Italian Gastroenterology centers from January 1, 2020, to June 30, 2021 (183 males, 167 females, mean age 64 years). ENTEROFLEGIN® proved effective in inducing remission in 9.34% and 17.64% of patients at 3 and 6 months, respectively (p<0.001). A reduction in symptoms was observed in 92.3% and 85.3% of patients at 3 and 6 months, respectively (p<0.001). Only 1.71% of patients experienced recurrence or worsening of symptoms during follow-up. FC levels decreased from 181.3 μg/g at baseline to 100.2 μg/g (p<0.001) and 67.9 μg/g (p<0.001) at 3 and 6 months of follow-up, respectively. No adverse events were reported during follow-up. Finally, acute diverticulitis occurred in only 2% of patients during the follow-up period.

Conclusion

ENTEROFLEGIN® proved effective in achieving symptom remission in patients with SUDD.

This nutraceutical also proved to be safe. Further randomized, placebo-controlled clinical studies will be needed to confirm these preliminary findings.

Bibliography

Giovanni BRANDIMARTE, Giovanni V. FRAJESE, Stefano BARGIGGIA, Danilo CASTELLANI, Andrea COCCO, Raffaele COLUCCI, Enrica EVANGELISTA, Antonietta G. GRAVINA, Domenico NAPOLETANO, Elisabetta NARDI, Tammaro MAISTO, Antonino MORABITO, Giuseppe PIANESE, Antonio ROMANO, Rodolfo SACCO, Luca SEDIARI, Nicola SINNONA, Lorenza TIFI, Alessandro D’AVINO, Walter ELISEI, Antonio TURSI. Performance of a multicompounds nutraceutical formulation in patients with symptomatic uncomplicated diverticular disease. Minerva Gastroenterology 2022;68.