Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909495111649 Date of Approval: 05/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment of Blastocystis Hominis infection ameliorates Hashimoto’s thyroiditis: Relation to IL-17
Official scientific title Treatment of Blastocystis Hominis infection ameliorates Hashimoto’s thyroiditis: Relation to IL-17
Brief summary describing the background and objectives of the trial Background: Hashimoto’s thyroiditis (HT) is one of the common autoimmune disorders that cause significant morbidity. T helper 17 cells and their hallmark cytokine IL-17 were identified as major contributing factors in the pathogenesis of HT. Blastocystis hominis (BH) infection is very common & has been shown to be associated with several diseases. Aim of the work: To determine serum IL-17 level in HT patients with & without BH infection and the effect of treating BH on IL-17 and thyroid parameters in patients with HT.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 12/12/2017
Actual trial start date 25/04/2018
Anticipated date of last follow up 25/04/2019
Actual Last follow-up date 03/07/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hashimotos thyroiditis with Blastocystis Hominis infection 500mg Nanazoxid 3 tablets/day 3 days Hashimotos thyroiditis with Blastocystis Hominis infection 20
Control Group Healthy subjects without HT and negative for BH no drugs in control group, just to compare with the experimental group no intervention in control group, just to compare with the experimental group no intervention in control group, just to compare with the experimental group 20 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with Hashimotos thyroiditis - Patients with Hashimotos thyroiditis and Blastocystis Hominis infection - Parasitic infections (other than Blastocystis hominis). - Autoimmune diseases (Other than Hashimoto’s thyroiditis). - Diabetes mellitus. - Cardiovascular diseases. - Malignancy & chronic inflammatory diseases. - Pregnant or breastfeeding women. - Patients receiving medications (including drugs affecting thyroid function). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 57 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/04/2018 Medical Research Institute ethical committee Alexandria University
Ethics Committee Address
Street address City Postal code Country
El-Horeya street Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect on serum IL-17 6 weeks after Blastocystis Hominis treatment
Secondary Outcome effect on thyroid profile 6 weeks after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main University Hospital Champlion street Alexandria 21111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Champlion street, El-Raml Square Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University Champlion Alexandria 21111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Medical Research Institute El-Horya Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Huda Farag hodafarag05@gmail.com +201003499772 El-Horeya
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Parasitology Medical Research Institute Alexandria University
Role Name Email Phone Street address
Principal Investigator Hanaa ElZawawy hanaaelzawawy@yahoo.com +201112253644 Champlion
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Endocrinology Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mona Tolba mona.tolba@alexu.edu.eg +201001870938 EL-Horeya
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor of Parasitology Medical Research Institute Alexandria University
Role Name Email Phone Street address
Public Enquiries Hanaa Abdelhalem hanaaabdalbasit@yahoo.com +201014048787 El-Horeya
City Postal code Country Position/Affiliation
Aleandria Egypt Researcher Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - Study protocol - patients' sheets - Patients and methods - Drug side effects - Patients investigations Study Protocol 2 years According to the quality of request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information