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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12611000918921 |
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Date of registration:
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29/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Triple Antibiotic Therapy in Symptomatic Blastocystis patients
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Scientific title:
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In patients with symptomatic Blastocystis, is triple antibiotic therapy effective in clearing Blastocystis from the stool and improving clinical well-being? |
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Date of first enrolment:
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09/08/2011 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12611000918921.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Dr Robyn Nagel
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Address:
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Suite 105, Medici Medical Centre
11 Scott St
Toowoomba
QLD
4350
Australia |
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Telephone:
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+61 7 46394124 |
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Email:
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robynnagel@tgclinic.com.au |
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Affiliation:
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Name:
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Dr Dr Robyn Nagel
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Address:
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Suite 105, Medici Medical Centre
11 Scott St
Toowoomba,
QLD
4350
Australia |
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Telephone:
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+61 7 46394124 |
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Email:
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robynnagel@tgclinic.com.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Gastrointestinal symptoms
No other cause except Blastocystis found on investigation
Good general health
Exclusion criteria: Allergy to Sulphurs
Pregnancy or risk of pregnancy
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Blastocystis infection;
Blastocystis infection
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Infection - Other infectious diseases
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Oral and Gastrointestinal - Inflammatory bowel disease
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Intervention(s)
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Administration of 14 days of oral capsule antibiotics: specifically trimethoprim/sulfamethoxazole 160/800mg twice daily, diloxanide furoate 500 mg three times daily and secnidazole 400mg three times daily
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Primary Outcome(s)
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Clearance of Blastocystis from stool specimen[Baseline, 15 day and 6 weeks after 14 days of antibiotic therapy]
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Secondary Outcome(s)
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Improvement in clinical well being; patient diary[baseline, day 15 and week 6 after antibiotic therapy]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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School of Veterinary Science, University of Queensland
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Ethics review
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Status: Approved
Approval date:
Contact:
Medical research Ethics Committee University of Queensland
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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