Hookworm Therapy for young people at high risk for colorectal cancer

Phase 1

• Conditions: colorectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12619001092189
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-08
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

A participant must meet the following criteria to be eligible for enrolment into the trial:
•Has provided written informed consent (PICF) and is willing to comply with all protocol scheduled visits, treatment plan, laboratory tests, and other trial procedures and in the opinion of the investigator has a good understanding of the protocol, the length of the study and the demands of the study
•Aged between 18-55 years
•Has a cumulative history of 2 or more conventional colorectal adenomata
•Has not received systemic antibiotic therapy in previous 3 months prior to baseline flexible sigmoidoscopy
•Has not received bowel preparation 3 months prior to baseline flexible sigmoidoscopy
•Is in reasonable health (ASA 1-2)
•Is not using aspirin, anti-platelet or anti-coagulant therapies
•If female, has met either of criterion a or b” below:
a) Is of non-childbearing potential as defined by amenorrhea for one year, or has had a hysterectomy and/or bilateral oophorectomy, or has had a tubal ligation at least 8 weeks prior to screening
b) If of childbearing potential and engaged in sexual activity with a potential for conception, must be willing to use an acceptable method of contraception

Exclusion Criteria

A participant must not meet any of the following exclusion criteria.
•Has any finding at screening that in the opinion of the investigator would compromise the safety of the participant or staff or affect the ability of the participant to adhere to protocol scheduled visits, treatment plan, laboratory tests, or other trial procedures
•Has a history of current tobacco consumption or who has a history of tobacco consumption with one year prior, or a current alcohol consumption exceeding two standard drinks per day

•Has a history of intolerance, allergy or hypersensitivity to the proposed anthelmintic – mebendazole

•Has a consistent usage of anti-inflammatory drugs (including prescription and OTC medications more than twice weekly)

•Has had a diagnosis of cancer which has been in remission for less than 5 years, excluding participants with adequately treated or excised basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

•Is an employee of the sponsor or study centre or immediate family of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite primary outcome including measurements of bacterial species richness (number of observed operational taxonomic units, OTUs) and bacterial species diversity (Shannon Index) in faecal and colon biopsy specimens, determined by shotgun metagenomic sequencing[Week 52 post hookworm inoculation]

Secondary Outcome Measures

Name	Time	Method
umber of adenomatous polyps assessed during colonoscopy at week 52 post hookworm inoculation[Week 52 post hookworm inoculation];General and Gastrointestinal Health Related Quality of Life Survey, designed specifically for this study[week 52 post hookworm inoculation];Cellular immune response in blood (complete blood count) including:<br>Haematocrit<br>Platelets<br>Mean Cell Volume<br>White cell count<br>Red cell count<br>Neutrophils<br>Lymphocytes<br>Monocytes<br>Eosiniphils<br>Basophils[week 52 post hookworm inoculation];An exploratory outcome analysis of the composition of the bacterial and immune profile of excised polypoid tissue, and how these may interrelate[week 52 post hookworm inoculation]