Table 1 World Health Organisation Trial Registration Data Set

Primary registry and trial identifying number

anzctr.org.au (ACTRN1261700818336)

Date of registration in primary registry

05/06/2017

Secondary identifying numbers

N/A

Source(s) of monetary or material support

Far North Queensland Hospital Foundation, Australian Institue of Tropical Health and Medicine

Primary sponsor

James Cook University

Secondary sponsor(s)

None

Contact for public queries

Prof Robyn McDermott

robyn.mcdermott@jcu.edu.au

Contact for scientific queries

Prof Robyn McDermott, Australian Institute of Tropical Health and Medicine, Cairns, Australia

Public title

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

Scientific title

Safety and tolerability of experimental hookworm infection in humans with metabolic disease: Proof of Concept (Phase 1b) clinical trial

Countries of recruitment

Australia

Health condition(s) or problem(s) studied

Diabetes, Infection

Intervention(s)

Active comparator: 20 or 40 larvae of the human hookworm Necator americanus (20 L3, 40 L3) over 24 months.

Placebo comparator: Tabasco sauce solution

Key inclusion and exclusion criteria

Ages eligible for study: 18–50 years; Sexes eligible for study: both; Accepts healthy volunteers: no

Inclusion criteria: Healthy adults 18–50 years, with central obesity (WC > 90 cm 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 type

Interventional

Allocation: block randomised; intervention model: parallel assignment; Masking: double-blind, sealed envelopes and containers

Primary purpose: prevention

Phase 1

Date of first enrolment

March 2018

Target sample size

45

Recruitment status

Recruiting

Primary outcome(s)

Safety of experimental inoculation 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 reactions: including but not limited to abdominal pain, rash, fever, weight loss, fatigue, nausea (mild, moderate or severe as assessed by trial doctor).

Key secondary outcome(s)

Changes in insulin sensitivity from blood pathology taken at each participant contact point during the 24-month trial; Change in BMI measured by any alteration in weight (kg) and height (cm); Change in waist circumference (cm) Change in bacterial richness of microbiome measure by shotgun assay of faecal sample