Efficacy and safety of gelatin tannate and tyndallized acid lactic bacteria in adults with chronic diarrhea and altered gut microbiota: A randomized, double-blind, placebo-controlled study

Objectives: Mucoprotectants, such as gelatin tannate, in combination with tyndallized acid lactic bacteria (GT), may offer advantages over live probiotics alone for the treatment of chronic diarrhea, a common presentation in primary care medicine and gastroenterology clinics. This study assessed the efficacy and safety of GT in adults with chronic diarrhea with an altered fecal microbiota, and effects on intestinal bacterial composition. Methods: In this prospective 4-week, randomized, double-blinded, placebo-controlled, multicenter post-marketing study of GT in adults with chronic diarrhea and an altered fecal microbiota, the primary FDA-based composite outcome, abdominal relief efficacy, by the clinical outcomes of abdominal pain intensity, stool consistency and frequency, was based on patients’ Likert scale assessments. Results: Among 191 patients randomized to GT or placebo, over 4 weeks’ treatment, GT was significantly more effective than placebo in improving abdominal pain intensity and stool consistency and frequency ( p = 0.001 for all). By study end, the overall abdominal pain relief responder rate was greater with GT than placebo, 79.1% vs 43.0% ( p < 0.001). Compared with baseline and placebo, the GT group showed statistically significant improvements in mean levels of most microbiota species assessed, including Faecalibacterium prausnitzii and Akkermansia muciniphila , suggesting an association between this correction and improvements in clinical outcomes. No adverse events (AEs) or treatment discontinuation due to AEs were reported. Conclusions: GT, a medical product that acts through a mechanical action on the gut wall, provides an effective and safe treatment option for adults with chronic diarrhea and an altered fecal microbiota composition.