Safety and tolerability of experimental hookworm infection in humans with metabolic disease

Phase 1

Active, not recruiting

• Conditions: Diabetes; infection; Metabolic and Endocrine - Diabetes; Infection - Studies of infection and infectious agents; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12617000818336
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-05
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Healthy adults 18-50 years, with central obesity (WC>90cm for females and >102 cm for males) and increased insulin resistance as assessed via abnormal homeostatic model assessment of insulin resistance (HOMA-IR), i.e. HOMA-IR > 2.12 or at least two other features of MetS: elevated blood pressure >135/85 mmHg, dyslipidaemia, or abnormal liver function test suggesting fatty liver disease. Have provided written informed consent and are willing to comply with all Protocol scheduled visits. If of childbearing potential, must be willing to use the acceptable methods of contraception.

Exclusion Criteria

Pregnancy, established chronic disease (CVD, diabetes, cancer, renal, gut disorder), history of substance abuse or current substance abuse, major allergies, known immunodeficiency disorder, asthma, taking prescribed medications or nutritional supplements likely to interfere with study outcomes, inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary, composite outcome will be the safety of experimental inoculation of participants with 20 L3, defined by (a) Number of reported adverse events (AEs), relative to placebo cohort, (b) Assessment of general health and (c) Successful completion of 24 month trial. Adverse reaction could include, but are not limited to, abdominal pain, rash, fever, weight loss, fatigue, nausea. These will be assessed by the trial Doctor as being mild, moderate or severe following clinical examination either by interview in person with trial participant or via phone/internet communication. These adverse events will be documented during each participant contact on the data collection database being maintained with all study data.[At completion of the 24 month trial. Participants will have direct contact with researchers at weeks -6, -4, 0 and 8, and at 6 months, 12 months, 18 months and 24 months. These contact points will be face to face, and the participants will undergo medical examination and questionaire completion.]

Secondary Outcome Measures

Name	Time	Method
Changes in Insulin Sensitivity from Blood Pathology taken at each particpant contact point during the 24 month trial[Measured at 6 months, 12 months, 18 months and 24 months];Change in BMI measured by any alteration in Body Mass (kg) as measured by weight scales relative to height.[Measured at 6 months, 12 months, 18 months and 24 months];Change in Waist Circumference (cm) measured by tape measure[Measured at 6 months, 12 months, 18 months and 24 months];Change in baterial richness of microbiome measure by shotgun assay of faecal sample[Samples taken for analysis at 6 months, 12 months 18 months and 24 months]