Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000918921
Ethics application status
Approved
Date submitted
2/08/2011
Date registered
29/08/2011
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Triple Antibiotic Therapy in Symptomatic Blastocystis patients
Scientific title
In patients with symptomatic Blastocystis, is triple antibiotic therapy effective in clearing Blastocystis from the stool and improving clinical well-being?
Secondary ID [1] 262909 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blastocystis infection 270473 0
Condition category
Condition code
Oral and Gastrointestinal 270627 270627 0 0
Inflammatory bowel disease
Infection 270798 270798 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 267106 0
Treatment: Drugs
Comparator / control treatment
Before and after; No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269355 0
Clearance of Blastocystis from stool specimen
Timepoint [1] 269355 0
Baseline, 15 day and 6 weeks after 14 days of antibiotic therapy
Secondary outcome [1] 279442 0
Improvement in clinical well being; patient diary
Timepoint [1] 279442 0
baseline, day 15 and week 6 after antibiotic therapy

Eligibility
Key inclusion criteria
Gastrointestinal symptoms
No other cause except Blastocystis found on investigation
Good general health
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to Sulphurs
Pregnancy or risk of pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Exclusion of other causes of gastrointestinal symptoms with clinical history, examination, routine blood tests and stool cultures and an upper and lower endoscopy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
9/08/2011
Date of last participant enrolment
Anticipated
Actual
20/02/2014
Date of last data collection
Anticipated
Actual
24/04/2014
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 269584 0
University
Name [1] 269584 0
School of Veterinary Science, University of Queensland
Country [1] 269584 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Veterinary Science
University of Queensland
Gatton Campus
Warrego Hwy
Gatton, QLD
4352
Country
Australia
Secondary sponsor category [1] 266618 0
Individual
Name [1] 266618 0
Dr Robyn Nagel
Address [1] 266618 0
Suite 105, Medici Medical Centre
11 Scott St
Toowoomba,
QLD
4350
Country [1] 266618 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269537 0
Medical research Ethics Committee University of Queensland
Ethics committee address [1] 269537 0
University of Queensland
Cumbrae-Stewart Building
Research Rd
Brisbane, Qld 4072
Ethics committee country [1] 269537 0
Australia
Date submitted for ethics approval [1] 269537 0
Approval date [1] 269537 0
02/06/2011
Ethics approval number [1] 269537 0
2011000454

Summary
Brief summary
We intend to evaluate the efficacy of 14 days of the triple antibiotics listed above in eradicating Blastocystis infection in symptomatic patients.
Trial website
Trial related presentations / publications
"Clinical pilot study: Efficacy of triple antibitoic therqpy in Blastocystis positive irritble bowel syndrome patients"
R Nagel, H Bielefeldt-Ohmann, R Traub
Gut Pathogens
6 (1), 34, 2014
Public notes

Contacts
Principal investigator
Name 32967 0
Dr Robyn Nagel
Address 32967 0
Toowoomba Gastroenterology Clinic
Suite 105, Medici Medical Centre
15 Scott St
Toowoomba
Queensland 4350
Australia
Country 32967 0
Australia
Phone 32967 0
+61 7 46394134
Fax 32967 0
Email 32967 0
[email protected]
Contact person for public queries
Name 16214 0
Dr Robyn Nagel
Address 16214 0
Suite 105, Medici Medical Centre
11 Scott St
Toowoomba,
QLD
4350
Country 16214 0
Australia
Phone 16214 0
+61 7 46394124
Fax 16214 0
+61 7 46394070
Email 16214 0
[email protected]
Contact person for scientific queries
Name 7142 0
Dr Robyn Nagel
Address 7142 0
Suite 105, Medici Medical Centre
11 Scott St
Toowoomba
QLD
4350
Country 7142 0
Australia
Phone 7142 0
+61 7 46394124
Fax 7142 0
+61 7 46394070
Email 7142 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBlastocystis specific serum immunoglobulin in patients with irritable bowel syndrome (IBS) versus healthy controls.2015https://dx.doi.org/10.1186/s13071-015-1069-x
N.B. These documents automatically identified may not have been verified by the study sponsor.