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Azithromycin Starts A Phase-II? Clinical Trial (AIDIT)

Discussion in 'Research' started by joshualevy, Mar 23, 2019.

  1. joshualevy

    joshualevy Approved members

    Joined:
    Dec 30, 2008
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    Azithromycin is an antibiotic which has been available since 1988, and is widely prescribed, with a good safety record. Antibiotics are effective in curing bacterial diseases, but not viral diseases. This trial is the first I've covered where an antibiotic was tested to treat, prevent, or cure type-1 diabetes, so it represents a new treatment path.

    Why Azithromycin?

    There are several different theories about what causes type-1 diabetes, one of which is that bacteria moving from the duodenum to the pancreatic duct causes type-1 diabetes. The duodenum is the part of the small intestine closest to the stomach. This is one of the "stomach flora" or "gut bacteria" theories which have been in the news recently.

    If the cause is bad bacteria in the pancreatic duct, then (these researchers theorize), maybe the cure is to give the patient a dose of antibiotics to kill the bacteria, extra insulin to lower the stress on the remaining beta cells, and dietary guidance to prevent excess bacteria from moving from the duodenum to the pancreatic duct in the future. All this would be done very quickly after diagnoses of type-1 diabetes. That is the quick summary of the rationale behind this clinical trial.

    This Clinical Trial

    This trial is called the "Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes (AIDIT)" to include all three of the interventions being used. This trial will enroll people between 6 and 16 years old, who have been diagnosed within the last 10 days, so only "just diagnosed" people can participate.

    The plan is to recruit 60 people, half of whom will get the treatment, and half will not. The study is not blinded. It started in Sept-2018 and they expect to finish in Dec-2021.

    People will get three doses of Azithromycin per week, which is based on a protocol which has been used for years to treat people with cystic fibrosis. On a monthly basis, they will be given extra insulin via an IV, which is designed to give beta cells a rest and help them regrow. Finally, they will also be given dietary advice designed to have them drink less at meals, and eat meals more slowly, which is designed to prevent bacterial migration.

    The study will run for a year, with C-peptide numbers being the primary end point. There are a total of 21 different secondary end points, including time within BG range, A1c, several measures of diet, quality of life, etc.

    They are recruiting at one site in Sweden:
    The Queen Silvia Children's Hospital / Sahlgrenska University Hospital, Gothenburg, Sweden
    Contact: Gun Forsander
    Contact: Olle Korsgren, MD, PhD +46176114187 olle.korsgren@igp.uu.se

    Funding is from Barndiabetesfondens (Child Diabetes Foundation) in Sweden.

    US Clincial Trial Record: https://clinicaltrials.gov/ct2/show/NCT03682640
    EU Clinical Trial Record: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002191-41/SE
    Wikipedia: https://en.wikipedia.org/wiki/Azithromycin

    Joshua Levy
    http://cureresearch4type1diabetes.blogspot.com
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
     

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