Magen-Darm- und Verdauungssystem

Abstrakt

Gelatine Tannate for the Treatment of Acute Diarrhoea in Adults

Alessandro Allegrini and Massimo Costantini

Gelatine tannate has been recently licensed as a medical device for the treatment of acute diarrhoea. Gelatine tannate is thought to act locally on the gut wall by forming a protective protein-based film and allowing the precipitation of pro-inflammatory mucoproteins from the intestinal mucus responsible for local inflammation, and subsequently eliminated through the faeces. In order to assess safety and efficacy of gelatine tannate, one randomised, parallel, double-blinded and placebo-controlled study was conducted by general practitioners in 40 adult patients diagnosed with acute diarrhoea (test formulation: capsules containing 500 mg of gelatine tannate). Safety was evaluated by monitoring adverse events (frequency, intensity and relation of adverse events to the administered treatments), laboratory parameters and vital signs between the pre- and post-study visits (primary study endpoints). Efficacy was evaluated in terms of mean decrease of both the daily frequency of watery stools (Stool Decrease Index, SDI) and the severity of the abdominal pain assessed using a 100-mm visual analogue scale (Pain Decrease Index, PDI). Statistical analyses were performed according to the principles of intention-to-treat and perprotocol. Gelatine tannate showed a good safety profile. No adverse events were reported in either active treatment or placebo arms. Gelatine tannate was significantly more effective than placebo (p < 0.01). In fact, adult patients treated with gelatine tannate had significantly less watery stools and less abdominal pain compared to patients treated with placebo. Gelatine tannate is an effective and safe treatment for acute diarrhoea in adults. The introduction of a viable treatment option based on a mechanical action could be an alternative to existing drugs for the treatment of acute diarrhoea. In fact, gelatine tannate is not absorbed systemically and acts locally to produce its effects on the gut wall, and thus may provide greater safety and tolerability compared to existing drug therapies.