Michigan Medicine sponsors diagnostic therapy trials for IBS

Thursday, January 11, 2018 - 8:22pm

Last Monday, Biomerica Inc. announced it would be partnering with Michigan Medicine on clinical trials for their Irritable Bowel Syndrome Diagnostic Guided Therapy.

IBS is a symptom-based disorder that may cause pain, constipation and bloating in the bowels. The syndrome affects between 25 million and 45 million patients in the United States, according to the International Foundation for Functional Gastrointestinal Disorders.

Biomerica’s diagnostic therapy, InFoods®, aims to help physicians identify certain foods that may be removed from a patient’s diet to alleviate IBS symptoms and discomfort. It may be used with drugs currently on the market because it is not considered a drug, but rather a form of therapy.

According to Dr. William Chey, director of medical services for the Michigan Bowel Control Program at Michigan Medicine, since IBS is a syndrome, not a disease, it could potentially be managed with this therapy.

“(IBS is) defined by characteristics,” Chey said. “It’s comprised of a number of different diseases. Thinking about ways that we can identify those diseases can provide a more precise approach.”

Chey sees the gastrointestinal system as central to our bodily functions, connected to seven organs. In his research, he examines the role of diet therapies in treatment. He said these approaches can actually treat some symptoms better than prescription medicine.

“These dietary modifications … work in about half the patients,” Chey said. “That’s fantastic, that’s better than medication for IBS.”

The study conducted by Michigan Medicine will be a double-blinded randomized controlled clinical trial which will enroll subjects at two trial sites: Michigan Medicine and the Beth Israel Deaconess Medical Center in Boston. The study will accept IBS patients with constipation and diarrhea as primary symptoms.

In an email interview, Lina Nahlawi, a clinical subjects coordinator at Michigan Medicine, wrote the study will rely on self-reporting from the subjects, which could lead to complications in the data seeing as though the study doesn't have a way to directly measure the impacts of the treatment.

“Dietary response will be assessed via daily symptom diary reports collected from participants throughout the study,” Nahlawi wrote.

Public Health student Takuro Miyazaki will be working as a study coordinator for the trials at the University. His interests lie largely in working to mitigate the effects of chronic disease. 

“(The diagnostic guided therapy) will help IBS patients to have more dietary modification options rather than chemicals and drugs, ultimately improving their quality of life and reducing healthcare costs,” he said.

In an article from NASDAQ, Zackary Irani, chairman and CEO of Biomerica, said discovering the root cause of IBS can lead to medical breakthroughs and alleviate symptoms for millions of patients.

“IBS remains a major burden for up to 45 million people in the United States who desperately seek some form of medical advancement providing symptom relief,” Irani said. “We believe our approach, supported by a Scientific Advisory Board and Strategic Advisory Board comprised of the leading minds in the IBS medical community, is differentiated by focusing on one possible root cause of IBS compared to simply treating symptoms.”

Chey said the study at Michigan Medicine should break ground in the diagnostic therapy field.

“This is really the first large-scale, systematic, phenologically rigorous attempt to validate diagnostic guided therapy for IBS,” Chey said.