Hookworm therapy for maintenance in ulcerative colitis:

Not Applicable

Completed

• Conditions: lcerative Colitis; Ulcerative Colitis; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12620000956909
• Lead Sponsor: Malaghan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-25
• Study Completion: 2022-07-01
• Last Update Posted: 12 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Has provided written informed consent and is willing to comply with all protocol scheduled visits, treatment plan, laboratory tests, and other trial procedures.
2) Aged 18-70
3) Have an endoscopic and histological diagnosis of ulcerative colitis for > 3 months
4) Ulcerative colitis is in remission (On stable dose of maintenance therapy for previous 3 months, and screening SCCAI<5 and faecal calprotectin<100)
5) Current ulcerative colitis maintenance medication is 5-aminosalicylic acid (5-ASA) (oral or rectal preparation) only

Exclusion Criteria

1) Anticipated to require endoscopic, radiological or surgical intervention during the study
2) Women who are pregnant, breast feeding, or planning on becoming pregnant during the study. All woman must have a negative pregnancy test prior to randomisation.
3) Woman of childbearing age not using adequate contraception (abstinence, oral contraceptive, intrauterine device, barrier method, surgical sterilisation, Depo-Provera, hormonal implant)
4) Asthma or asthma symptoms requiring any treatment within 5 years of screening visit
5) Eosinophilic lung disease or other active respiratory disorder
6) Current or recent serious systemic disorder including clinically significant impairment in cardiac, pulmonary, renal, endocrine, haematological, or neurologic function, based on investigator discretion
7) Currently receiving the following medication:
- Immunosuppressant medication (other than 5ASA) within 3 months from day 0 (including but not limited to prednisone, budesonide, thiopurines, methotrexate, biologics)
- NSAIDs within 2 weeks from day 0
- Treatment with anti-parasitic or antibiotics medication within 2 weeks prior to day 0
8) Presence of any of the following laboratory parameters at screening
- Hb <100
- WCC <4 or >20
9) Known immunodeficiency disease including HIV, HBV, HCV
10) Evidence of infective colitis including C.diff, bacterial enteric pathogens or pathogenic ova/parasites
11) History of malignancy within the past 5 years, excluding BCC or SCC of the skin or cervical carcinoma in situ
12) History of colonic dysplasia
13) Other clinically significant disease that could interfere with protocol compliance or interpretation of results
14) Intolerance, allergy or hypersensitivity to capsaicin or ingredients
15) Intolerance to mebendazole
16) Intolerance to the chemicals used to prepare N.americanus

Study & Design

• Study Type: Interventional
• Study Design: Not specified