Have a gut-swrenching disorder that has made the bathroom your best friend? How about swallowing a bunch of worm eggs to fix it?
That potential treatment is being tested in two Austin locations and more than 60 others around the country. This clinical trial involves ingesting 7,500 microscopic pig whipworm eggs every two weeks to combat Crohn’s disease, a chronic inflammatory condition of the gastrointestinal tract.
Crohn’s is an autoimmune disorder, which means the patient’s immune system is hyperactive and mistakenly attacks the body’s healthy cells. Crohn’s causes cramping, abdominal pain and diarrhea in 400,000 to 600,000 people in North America — most of them adolescents and young adults.
But patients with the unpleasant disorder are not breaking down any doors in Austin — so far — to try out the stomach-churning treatment. That’s despite an earlier, promising study using the parasitic worms for Crohn’s in which 79 percent of patients had an easing of symptoms and 72 percent of them went into remission. Of patients with a related disorder, ulcerative colitis, 43 percent felt better after treatment.
“It’s a hard sell,” said Dr. John Ziebert, an Austin gastroenterologist who is seeking to enroll patients in the study. “There is the ick factor to get over.”
Study participants swallow the eggs in a solution that tastes a little salty, Ziebert said. After ingesting the eggs, the larva hatch and attach to the intestinal wall. There, the worms regulate the immune system, which prevents it from attacking the body’s own tissues and organs. The bacterial makeup of the intestine also seems to change, according to a November paper by Joel Weinstock. He researched the treatment and is a scientific adviser to Coronado Biosciences, the Burlington, Mass., company sponsoring the trial.
Weinstock said he came to the treatment after wondering why autoimmune conditions like inflammatory bowel disease were increasing. “Was it possible that improved hygiene, by ridding our bodies of parasitic worms and beneficial bacteria alike, made way for the new problem” of autoimmunity? he wrote.
That “hygiene hypothesis” is intriguing, Ziebert said.
“It’s interesting when we look at a map of the world,” he said. “People in more developed countries have fewer parasitic infections and more autoimmune disease and people in less-developed countries have more parasitic infections and less autoimmune disease.”
Coronado is testing the treatment or planning trials for other disorders, including multiple sclerosis, Type 1 diabetes and even autism.
For the Crohn’s trial, the company wants to enroll 220 people, half of whom will drink the worm eggs and half of whom won’t. A study partner in Germany spearheading the European part of the study hopes to enroll 300. Doctors and patients won’t know which ones are swallowing the eggs.
“They have to have moderately to severe disease, ” Ziebert said. “It gives our patients an option who have not had success with medications.”
Asked if there was any similar treatment, he said it could be compared to an experimental therapy for people with bowel disease: transplanting feces from a healthy person into another to treat a stubborn and sometimes deadly bacterial infection called Clostridium difficile.
“Talk about ick factor,” Ziebert wrote in an email.
The Crohn’s and Colitis Foundation of America said that concerns have been raised about “the safety of therapeutic ingestion of Trichuris suis,” the whipworm’s name. “Humans are not the usual host for this parasite and its presence in the human GI tract is not well studied or predictable,” the foundation said in a written statement.
The worms should only be used “in the context of properly supervised clinical research trials,” it said.
The trial, which began last year, is testing for safety and effectiveness. Few side effects, aside from diarrhea and abdominal cramping, have been reported, said Ziebert and Dr. Karin Hehenberger, Coronado’s chief medical officer.
The Motley Fool, a multimedia financial-services company, said in an article last month that investors gave the company a low rating, probably because of the worm trial. The author-analyst called the potential treatment “far fetched to the border of insanity.”
Hehenberger said she did not understand why the author reached that conclusion, adding that the company has “enough cash to last through this trial and beyond.”
As a potential treatment, “I think it’s extremely clever if we can show it works,” she said. “It’s a new way of approaching disease.”
If all goes well, the treatment could be commercially available in the next four or five years, Hehenberger said.
CORRECTION: An earlier version of this story used an incorrect word to describe the effect of worms used in a trial on the immune system. They regulate it. Also, Coronado Biosciences is not testing the worm treatment in allergy patients.
Central Texas residents with moderate-to-severe Crohn’s disease who are between 18 and 64 may be eligible for the clinical trial using pig whipworms. Those interested in enrolling with Dr. John Ziebert of Austin can contact his study coordinator, Erica Sherrill at Professional Quality Research, at 374-0677 or by email at firstname.lastname@example.org. Enrollment closes May 31, Sherrill said.