Last week, U.S. health officials approved a new pill. Scientists made the capsule from healthy bacteria. The medicine will help fight dangerous gut infections. But it’s a tough pill to swallow.
The human body is one of God’s most complex creations. There is much that scientists don’t know. But research continues to make new discoveries that help image-bearers deal with illness—even if the techniques might be a bit unpleasant.
More than 10 years ago, some doctors began reporting success with fecal transplants. The strange-sounding practice uses stool from a healthy donor to transfer beneficial bacteria that restores the gut’s healthy balance and prevents reinfections. The transplants can help patients with serious bowel issues.
Meanwhile, the new treatment provides a simpler pill version of the full transplant method. The Food and Drug Administration cleared the capsules for those 18 and older who face risks from repeat infections. Dangerous bacterial Clostridium difficile infections can cause severe nausea, cramping, diarrhea—and sometimes death.
Antibiotics can kill the bacteria, but they also destroy good gut bacteria. That leaves intestines more open to future infections.
The new capsules are approved for patients who have already received antibiotic treatment. They will be sold by Seres Therapeutics under the brand name Vowst. They will involve a dozen pills: four daily for three days.
Seres Therapeutics starts with stool provided by donors who are screened for various health risks and conditions. The stool is tested for dozens of possible viruses, infections, and parasites.
The company then processes the samples to remove waste, isolate healthy bacteria, and kill any other lingering organisms. Technicians can make thousands of capsules from each sample. That makes the process more efficient than current fecal transplants, according to the company.
Despite its approval, the FDA warns that the drug “may carry a risk of transmitting infectious agents. The agency notes that “It is also possible for Vowst to contain food allergens.”
Seres executives say their manufacturing process is safe. It relies on the same techniques and equipment used to purify blood products and other biologic therapies.
The FDA approved the treatment based on a 180-patient study. In the tests, nearly 88% of patients who took the capsules did not experience reinfection after eight weeks. However, 60% of those who received dummy pills did have another infection.
The new options are expected to decrease demand for donations from stool banks. But some plan to stay open. OpenBiome is the largest stool bank in the United States. The group says it will keep serving patients who aren’t eligible for the FDA-approved products—such as children and adults whose cases resist treatment.
(Technicians prepare oral microbiome drugs for clinical studies. Genevieve de Manio/Seres Therapeutics via AP)
