April 27, 2023 – People with the painful and infrequently recurring type of the bacterial infection generally known as C. diff can now receive a helpful treatment called stool transplant therapy by simply swallowing a pill.
The FDA approved the treatment, called Vowst, this week. Until now, stool transplants have only used a more invasive method, transferring the donor stool using a colonoscope, the instrument utilized in a colonoscopy.
Infection with the bacteria It is difficult (CDI) typically occurs in healthcare settings and is commonly related to an imbalance within the gut after an individual takes antibiotics. Symptoms include diarrhea, abdominal pain, and fever, but severe infections can result in organ failure and death.
“Administration of fecal microbiome is intended to facilitate restoration of gut flora and thus prevent further episodes of CDI,” the FDA stated in its approval notice.
Up to 1 in 4 individuals who change into infected with the infection experience Recurrenceand every time the infection returns, the likelihood of one other attack increases. According to the FDA, between 15,000 and 30,000 people die every year from It is difficult Infection.
In a study of 182 people, 12% of individuals taking Vowst experienced a relapse over 8 weeks, in comparison with 40% of individuals taking a placebo, in accordance with the FDA.
Each Vowst capsule accommodates live bacteria extracted from human stool from screened donors. The Vowst dosing schedule calls for 4 capsules taken orally once each day for 3 days in a row.
The company that makes Vowst, Seres Therapeutics, expects the product to be available in June.
“Recurring It is difficult “The infection significantly impacts patients' quality of life, both physically and emotionally, and many live in great fear of future relapses,” Christian John Lillis, executive director of the Peggy Lillis Foundation for C. diff Education and Advocacy, said in a press release. “Patients await new treatment options that address a central concern: preventing another CDI relapse.”