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Single-dose gel cures ear infections in pre-clinical trial

A new gel could deliver a full course of antibiotics for middle-ear infections in a single treatment, according to a pre-clinical study published Wednesday.

The gel, bio-engineered by Boston Children’s Hospital and its partners, would improve upon oral antibiotic treatments, which are usually given in multiple doses over a period of 7 to 10 days.

Parents sometimes stop administering medication when it seems like the child is getting better, which results in a recurrence of the infection, according to the study published in the Journal Science Translational Medicine.

“Force-feeding antibiotics to a toddler by mouth is like a full-contact martial art,” said Dr. Daniel Kohane, the study's senior investigator and director of the Laboratory for Biomaterials and Drug Delivery at Boston Children's in a press release.

Ear infections are the most common reason children visit a doctor, according to a fact sheet from the National Institutes of Health, National Institute on Deafness and Other Communication Disorders. Five out of every six children will experience an ear infection by the time they are 3 years old.

The new gel, which has only been tested on animals, is designed to make treatment easier on both the child and the parent. The gel is administered by squirting it into the middle ear, where it hardens and gradually dispenses antibiotics.

“The gel sits against the ear drum and would not be dislodged with a finger,” Rong Yang, Chemical engineer and first author on the paper told AMI Newswire. “The gel automatically degrades after three weeks, leaving no residue in the ear canal and causing no tissue damage.”

There is still some debate in the medical community as to whether antibiotics should be prescribed for middle-ear infections. A review published in 2015 by Cochrane Acute Respiratory Infections Group found that antibiotics were not very useful for children with middle-ear infections. The review of 3,401 children between 2 months and 15 years old found that antibiotics resulted in no reduction in pain at three to seven days and 11 to 14 days after treatment.

A page on the Centers for Disease Control website titled Get Smart: Know When Antibiotics Work states: “Antibiotics are not recommended to help treat many ear infections.”

Ear infections can be caused by bacteria or by viruses. Bacterial infections may improve with antibiotics, but viral infections will not. The CDC warns that taking antibiotics can kill healthy bacteria and can increase a patient’s risk of contracting an antibiotic-resistant infection.

However, the Chochrane review found that antibiotics slightly reduced the number of children with perforations of the eardrum and reduced the incidence of an infection in one ear spreading to the other. In that review, antibiotics were shown most effective in children younger than 2 with infections in both ears and in children with discharge from the ear.

Researchers hope the gel will help reduce the negative effects of antibiotics on children. Treating the infection at the source means lower doses will be needed, which should reduce side effects, including diarrhea and rashes.

Initial testing on chinchillas, which have a hearing range and ear structure similar to humans, found that the gel cured middle-ear infection, leaving no antibiotics in the bloodstream.

The gel itself is the result of eight years of research by the Laboratory for Biomaterials and Drug Delivery at Boston Children’s. It uses chemical permeation enhancers, which have been FDA-approved in other applications, to allow antibiotics to seep through the ear drum.

Yang told AMI that the research team is preparing for human trials. The main question left to be answered is whether the gel will be as safe and effective in humans as it has been in chinchillas.

“The clinical development of a new treatment is a complicated process. It is hard to predict when it will be implemented, but we hope it can be in a few years,” Yang said.