Ingestible pellets containing a charcoal-like treatment — designed by the French company Da Volterra — can stop the microbiome from being disrupted in hospitalized patients treated with antibiotics.
The treatment also showed the potential to reduce the risk of Clostridium difficile gut infections in a phase II trial.
When patients are given antibiotics for infections, some of the drug dose that isn’t absorbed in the small intestine can end up in the colon. Here, the excess antibiotic can disrupt the gut microbiome, allowing harmful bacteria such as Clostridium difficile to cause chronic, and sometimes fatal, infections.
Da Volterra’s treatment consists of ingestible pellets containing a charcoal-based adsorbent, which sticks to antibiotic molecules. Once the pellets reach the colon, they dissolve and release the adsorbent, preventing the antibiotics from harming gut bacteria.
Da Volterra’s phase II trial aimed to test the safety of the treatment in 260 hospitalized patients that were receiving oral fluoroquinolone antibiotics to treat infections, along with medications for other conditions. The treatment met the primary endpoint of the trial, proving as safe as antibiotics given alone. The treatment also significantly reduced antibiotic levels in feces without sabotaging the drugs’ ability to treat the target infection, and prevented C. difficile from growing in fecal samples.
Da Volterra’s trial wasn’t big enough to demonstrate significant reductions in clinical C. difficile infections. However, the company now aims to confirm the benefits of the treatment for the microbiome in a phase III trial, though hasn’t specified when.
According to Annie Ducher, CMO at Da Volterra, the study was also promising because “it confirms that [the treatment] can be safely administered in patients with several comorbidities and concomitant medications without risk of interfering with these medications.”
The treatment also showed the potential to tackle the looming threat of antibiotic resistance in a phase I trial in 2018.
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