Grant Supports Study of Device in Easing Abdominal Pain in Children

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by Patricia Inácio, PhD |

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A pediatric gastroenterologist in Missouri has been awarded a $50,000 grant to open a study into the potential of an FDA-approved nonsurgical device, called IB-Stim, as a way of easing abdominal pain in children with cystic fibrosis (CF).

The grant, by the Institute of Clinical and Translational Sciences (ICTS), was awarded to Dhiren Patel, MD, an associate professor of pediatrics at Saint Louis University (SLU)’s School of Medicine and a SLUCare pediatric gastroenterologist.

IB-Stim is approved in the U.S. to treat abdominal pain associated with irritable bowel syndrome in children and adolescents, ages 11-18.

“If we discover that it works [for CF], then the next phase is to submit our statistical findings to the Cystic Fibrosis Foundation and apply for larger grant funding to conduct a double-blinded placebo-controlled randomized clinical trial,” Patel said in a press release.

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Patel, with a research focus on CF-related gastrointestinal symptoms, launched the pediatric gastrointestinal motility program at SSM Health Cardinal Glennon Children’s Hospital.

“Over the time, I had several questions about cystic fibrosis intestine and motility compared to normal gut motility,” he said. “This area has not been explored in medicine.”

CF is characterized by the buildup of abnormally thick and sticky mucus in the lungs, liver, pancreas, and intestines. While most disease manifestations are respiratory, gastrointestinal symptoms in children with CF are common and frequently occur before the onset of lung symptoms.

“Abnormal GI [gastrointestinal] tract function and long-standing abdominal pain seem to impair the quality of life the most,” Patel said. “That’s what my team and I are trying to address with newer innovative methods with this research.”

IB-Stim sends gentle electric impulses to nerve bundles in the ear that stimulate areas of the brain involved in the processing of pain.

Patel’s team will open a study to assess the responses of CF patients, ages 11 to 18, after four consecutive stimulations with the device.

The study, “Neuromodulation with Percutaneous Electrical Nerve Field Stimulation for Children with Cystic Fibrosis Experiencing Chronic Abdominal Pain,” is being supported by ICTS, a Washington University-led research consortium that includes SLU.

Sticky mucus that builds in digestive tract organs can block the intestines, particularly in newborns, a condition known as meconium ileus. In meconium ileus, the contents of a baby’s bowel (the meconium) are abnormally thick and sticky, leading to an obstructed bowel.