Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001406897
Ethics application status
Approved
Date submitted
31/08/2021
Date registered
19/10/2021
Date last updated
17/01/2024
Date data sharing statement initially provided
19/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Fucoidan for eosinophilic oesophagitis: a phase 2 pilot study
Scientific title
Efficacy of Fucoidan for eosinophilic oesophagitis: a phase 2 pilot study
Secondary ID [1] 305066 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Oesophagitis 323272 0
Condition category
Condition code
Inflammatory and Immune System 320845 320845 0 0
Allergies
Oral and Gastrointestinal 320846 320846 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be treated with steroids and proton pump inhibitor (PPI) therapy for a minimum of 6 weeks as part of the routine clinical management (prescribed by Gastroenterologist and/or in consultation with participants own GP). Only the study medication will be provided as part of the study. Participants will take the study medication in combination with routine clinical management for an initial period of 6 weeks, and then continue taking the study medication for a further 6 weeks (Total fucoidan/placebo supplementation will be 12 weeks). Participants will be randomised to one of two treatment groups.
(i) A formulation containing 100mg daily of 85% Maritech® (Marinova, Tasmania, Australia).
(ii) Placebo: same formulation as the fucoidan supplement but without the active ingredient

The active treatment will be administered via an oral gel, once per day. Participants will be asked to drink the gel slowly, allowing it to coat the oesophagus thoroughly, and asked to refrain from eating for 30 minutes afterwards.

To monitor compliance, participants will be asked to complete a daily symptom and medication diary, as well as take part in a follow up phone call at the half way point of the study (6 weeks). A text message/email reminder will be sent out twice per week. Participants will also be asked to return the bottle of supplement at the completion of the study for the research team to measure overall compliance.
Intervention code [1] 321460 0
Treatment: Drugs
Comparator / control treatment
Patients will be treated with either the active ingredient or the placebo control. The placebo control is the same formulation as the treatment group, minus the active (Fucoidan) ingredient.

The placebo medication will be administered via an oral gel, once per day. Participants will be asked to drink the gel slowly, allowing it to coat the oesophagus thoroughly, and asked to refrain from eating for 30 minutes afterwards.

To monitor compliance, participants will be asked to complete a daily symptom and medication diary, as well as take part in a follow up phone call at the half way point of the study (6 weeks). A text message/email reminder will be sent out twice per week. Participants will also be asked to return the bottle of supplement at the completion of the study for the research team to measure overall compliance.
Control group
Placebo

Outcomes
Primary outcome [1] 328643 0
Change in EOE disease activity based on oesophageal eopsinophil count
Timepoint [1] 328643 0
13 weeks post treatment initiation.
Primary outcome [2] 329006 0
Change in EoE disease activity based on change in Dysphagia Symptom Questionnaire score of >30%
Timepoint [2] 329006 0
13 weeks post treatment initiation
Secondary outcome [1] 399803 0
Oesophageal microbiome: diversity score (count of identified operational taxonomic units).
Timepoint [1] 399803 0
13 weeks post treatment initiation
Secondary outcome [2] 401144 0
Oesophageal biopsy immune gene expression profiling: the ratio of Th /Th2 inflammatory pathways and cells
Timepoint [2] 401144 0
13 weeks post treatment initiation
Secondary outcome [3] 401207 0
Faecal microbiome: diversity score (count of identified operational taxonomic units)
Timepoint [3] 401207 0
13 weeks post treatment initiation
Secondary outcome [4] 401905 0
Oesophageal microbiome: Microbial composition
Timepoint [4] 401905 0
13 weeks post treatment initiation
Secondary outcome [5] 401906 0
Faecal microbiome: Microbial composition
Timepoint [5] 401906 0
13 weeks post intervention initiation

Eligibility
Key inclusion criteria
- Be aged 18-60 years;
- Have EoE diagnosed from oesophageal biopsy, based on eosinophil count greater than15 cells per high powered field;
- Be prescribed treatment with steroids and proton pump inhibitor (PPI) therapy for a minimum of 6 weeks as part of the routine clinical management and continue taking the study medication for a further 6 weeks.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Report antibiotic, probiotic or symbiotic use in the previous 14 days;
- Report gastrointestinal or respiratory disease, autoimmune disease or other diseases, in particular Crohn’s Disease or Ulcerative Colitis;
- Return a finding of malignancy on biopsy results post gastroscopy procedure.
- Allergic, sensitive or intolerant to (one of) the ingredients of the study product

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/02/2023
Actual
16/06/2023
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
36
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20279 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment postcode(s) [1] 35018 0
4224 - Tugun

Funding & Sponsors
Funding source category [1] 309462 0
Commercial sector/Industry
Name [1] 309462 0
Marinova Pty Ltd
Country [1] 309462 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
58 Parklands Drive, Southport, QLD, 4215
Country
Australia
Secondary sponsor category [1] 310433 0
None
Name [1] 310433 0
Address [1] 310433 0
Country [1] 310433 0
Other collaborator category [1] 281952 0
Individual
Name [1] 281952 0
Dr Ben Allen - Gold Coast Gastro Care/John Flynn Hospital
Address [1] 281952 0
Suite 5A, John Flynn Medical Centre, 42 Inland Dve, Tugun, QLD, 4224
Country [1] 281952 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309254 0
Ramsay Health Human Research Ethics Committee
Ethics committee address [1] 309254 0
Ethics committee country [1] 309254 0
Australia
Date submitted for ethics approval [1] 309254 0
19/07/2021
Approval date [1] 309254 0
17/08/2021
Ethics approval number [1] 309254 0
21/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113506 0
Dr Nicholas West
Address 113506 0
Griffith University Gold Coast Campus - G40_9.17 - 58 Parklands Drive, Southport, QLD, 4215
Country 113506 0
Australia
Phone 113506 0
+61 0756780899
Fax 113506 0
Email 113506 0
n.west@griffith.edu.au
Contact person for public queries
Name 113507 0
Rebecca Morgan
Address 113507 0
Griffith University Gold Coast Campus - G40_4.59 - 58 Parklands Drive, Southport, QLD, 4215
Country 113507 0
Australia
Phone 113507 0
+61 0756780358
Fax 113507 0
Email 113507 0
rebecca.morgan@griffith.edu.au
Contact person for scientific queries
Name 113508 0
Nicholas West
Address 113508 0
Griffith University Gold Coast Campus - G40_9.17 - 58 Parklands Drive, Southport, QLD, 4215
Country 113508 0
Australia
Phone 113508 0
+61 0756780899
Fax 113508 0
Email 113508 0
n.west@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data is only shared with the individual participants themselves.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12911Study protocol    382612-(Uploaded-17-08-2021-14-11-12)-Study-related document.docx
12912Informed consent form    382612-(Uploaded-17-08-2021-14-11-23)-Study-related document.doc
12913Ethical approval    382612-(Uploaded-31-08-2021-12-12-10)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.