Worms and metabolism - clinical trial
This clinical research study compare groups of young overweight women who are at high risk for developing diabetes. The study aims to use hookworm as a possible therapy for those at risk of Type 2 Diabetes and improve overall metabolic health.
Contact us
Phone: 0439 923 422
Email: wam@jcu.edu.au
Project timeline: From November 2017 to November 2019
Plan for the first recruitment: November 2017
Trial phase
Why is this study important?
Obesity and Type 2 Diabetes are increasing in our population and lead to disability and early death from kidney failure, heart disease and infections. In women, the early warning signs include obesity, high blood pressure, glucose and blood fats. When young women have diabetes during pregnancy this increases the likelihood that the woman will experience diabetes later in life, and also raises the risk of diabetes in early life of the child.
Some research in mice suggests that worm infections change the gut microbiota and release anti-inflammatory molecules that slow inflammation throughout the body thus protecting against progression to diabetes.
This study seeks to observe these effects in women with a waist circumference of 90cm+, and establish whether worms can change the gut microbiota and immune system response that improves metabolic and immune function.
Researchers have previously developed hookworm as an experimental treatment. This means that it has not been approved by Australia’s regulatory authority, the Therapeutic Goods Administration (TGA) for treatment in Australia. The safety of this introducing hookworm into patients has previously been demonstrated in patients suffering from coeliac disease, Crohn’s disease and asthma where larger clinical trials have been undertaken by members of this research team at JCU.
This is the first trial of this treatment in otherwise healthy people at high risk of metabolic syndrome and T2DM.
Participation
What will I be asked to do?
This study goes for 24 months and first appointments are scheduled for November 2017.
During the study, the study team will:
- Ask you to complete questionnaires about your general health and mood (PHQ-9)
- Inoculate you (on the forearm) with a dose of hookworm larvae or placebo
- Monitor your health and safety from blood, urine and faeces samples and medical assessments
- Ask you to complete a diary for your dietary intake
Participants will be asked to have:
- A screening visit
- A baseline visit
- Commence treatment
- Randomisation/inoculation
- Follow up
- Option for extension
What are the benefits of taking part in the study?
We cannot guarantee or promise that you will receive any benefit from this research. However, participation might provide important medical information about hookworm compounds as a treatment for metabolic and other immune/inflammatory diseases and this information may help people who have been diagnosed with these diseases in the future.
What are the possible risks of taking part?
For those participants who are provided the hookworm infection, initial skin itchiness and rash at the inoculation site are common. First contact with hookworms may also cause some mild abdominal upset and all participants will be closely monitored. For those participants who receive the placebo mild skin itchiness and rash can occur in response to contact with chilli. Participants may have pain or bruising on the arm where the blood samples are taken. You may also have some bleeding, infection, or clotting at the site of the needle stick. Some people may feel faint or lightheaded for a few minutes after having blood taken. If this happens, it can be easily treated.
Am I excluded from participating?
Some reasons you may not be allowed to take part in this study include:
- You are a woman who is pregnant, breastfeeding, or plan on becoming pregnant during the study period.
- You have a history of or current infection with hepatitis B virus, hepatitis C virus, HIV, or another condition that could affect the study results or make it unsafe for you to take part.
- You have a history of problems with other chronic diseases e.g. reduced respiratory functioning, cardiac problems etc. that may impact on your safety to participate in the study.
- You have a history of reactions to any of the study treatments.
- You have recently taken, are taking, or will need to take certain medicines or substances that are not allowed in this study.
- You are or have been previously misusing or dependent on illegal drugs or alcohol now or in the past.
- You have recently (within 30 days of screening) or are currently taking part in another investigational study.
- You have poor venous access so that the blood tests may not be able to be done.
What about confidentiality?
This study has been reviewed and approved by the Human Research Ethics Committee at James Cook University. All information collected will be treated confidentially and will be used for health research only. No information will be released in a way that would allow an individual to be identified.
Complaints
Complaints can be made in a confidential manner to any member of the study team, or by directly contacting the:
Ethics Officer
Human Research Ethics Committee
James Cook University
Phone: (07) 4781 5011
Email: ethics@jcu.edu.au
How can I participate in the study?
Please contact our trial co-ordinator
Phone: 0439 923 422
Email: wam@jcu.edu.au
The team:
- Professor Robyn McDermott
- Dr Paul Giacomin
- Dr Lea Merone
- Professor Alex Loukas
