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Trial registered on ANZCTR


Registration number
ACTRN12623001061628
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
4/10/2023
Date last updated
4/10/2023
Date data sharing statement initially provided
4/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Trial to Assess if a Turmeric Based Product is Beneficial for Adults Diagnosed with Eosinophilic Oesophagitis
Scientific title
A Pilot Feasibility Trial of Curcutex (Meriva® Curcumin Phytosome®) for Adults Diagnosed with Eosinophilic Oesophagitis
Secondary ID [1] 310337 0
None
Universal Trial Number (UTN)
Trial acronym
MCP4EoE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Oesophagitis 331069 0
Condition category
Condition code
Inflammatory and Immune System 327859 327859 0 0
Allergies
Oral and Gastrointestinal 327860 327860 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 327861 327861 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 capsule of Curcutex (Meriva® Curcumin Phytosome® 500 mg per capsule) twice daily (500 mg per dose, orally with breakfast and dinner) for 12 weeks. Participants will be advised to send a photo of the remaining investigational product at each follow up appointment (week 4, 8 and 12) so that the number of remaining capsules can be counted and confirmed by the researcher. Participants will be instructed to take any products remaining at study completion to their local pharmacy for disposal. Intervention use also will be recorded in a self-reported daily participant diary.
Intervention code [1] 326741 0
Treatment: Other
Comparator / control treatment
2 capsules of Curcutex (Meriva® Curcumin Phytosome® 500 mg per capsule) twice daily (1000 mg per dose, orally with breakfast and dinner) for 12 weeks. Participants will be advised to send a photo of the remaining investigational product at each follow-up appointment (i.e. weeks 4, 8 and 12) so that the number of remaining capsules can be counted and confirmed by the researcher. Participants will be instructed to take any products remaining at study completion to their local pharmacy for disposal. Intervention use also will be recorded in a self-reported daily participant diary.
Control group
Dose comparison

Outcomes
Primary outcome [1] 335708 0
Feasibility (recruitment success) will be measured using routinely collected recruitment data (i.e., number of expressions of interest, ability to meet the recruitment target of 30 participants enrolled in the allocated timeframe, and drop-outs).
Timepoint [1] 335708 0
These outcomes will be measured using routinely collected recruitment data (i.e., number of expressions of interest, enrolments, and drop-outs), which will be collected by the researcher throughout the trial period, and via an end of study survey, which will be self-administered online by participants at week 12 post-commencement of intervention (baseline).
Feasibility (recruitment success) will be measured throughout the trial period and determined after 8 months.
Primary outcome [2] 336034 0
Feasibility (patient experience), defined in the context of this study as the patients’ self-reported experiences related to trial logistics [i.e., blood collection, outcome measurements and appointments], will be measured at week 12 using a non-validated end of trial evaluation questionnaire designed specifically for this study, as well as a participant diary at weeks 4, 8 and 12. Both of these measures will be self-administered online by participants.
Timepoint [2] 336034 0
Feasibility (patient experience) will be measured at week 4, 8 and 12 post-baseline using a participant diary, and at week 12 using the end of trial evaluation questionnaire.
Primary outcome [3] 336035 0
Feasibility (acceptability and satisfaction with the intervention), defined in the context of this study as satisfaction with the intervention, will be measured at week 12 using a non-validated end of trial evaluation questionnaire designed specifically for this study, as well as a participant diary at weeks 4, 8 and 12. Both of these measures will be self-administered online by participants.
Timepoint [3] 336035 0
Feasibility (acceptability and satisfaction with the intervention) will be measured at week 4, 8 and 12 post-baseline using a participant diary, and at week 12 post-baseline using the end of trial evaluation questionnaire.
Secondary outcome [1] 425247 0
Safety is defined in this study as the absence of side effects and adverse events (AEs; new symptoms not previously experienced by the participant). Side effects and AEs will be recorded in a self-reported participant diary.
Timepoint [1] 425247 0
The diary will be collected at weeks 4, 8 and 12 post-baseline.
Secondary outcome [2] 425248 0
Severity of EoE-related symptoms will be measured using the Brief Esophageal Dysphagia Questionnaire (BEDQ). The BEDQ is a validated 8-item participant-administered instrument that uses a 14-day recall period to assess the frequency and intensity of EoE-related dysphagia.
Timepoint [2] 425248 0
The BEDQ questionnaire will be self-administered by participants at weeks 0, 4, 8, and 12 post-baseline.
Secondary outcome [3] 425249 0
EoE-related quality of life is defined as “an individual’s perceived physical and mental health over time”. This outcome will be measured using the Eosinophilic Oesophagitis Quality of Life Scale for Adults (EoE-QoL-A), version 2.0. The EoE-QoL-A is a validated disease-specific health-related QoL (HRQoL) measure for adults with EoE. The 24-item scale has a 6-question addendum for those on an elimination or elemental formula diet, and encompasses five domains: eating/diet impact, social impact, emotional impact, disease anxiety and choking anxiety. The EoE-QoL-A is the most widely used and well-established measure for assessing HRQoL in EoE
Timepoint [3] 425249 0
The scale will be self-administered by participants at weeks 0, 4, 8 and 12 post-baseline.
Secondary outcome [4] 425250 0
Absolute Eosinophil Count (AEC) is defined as the total number of eosinophils in an individual’s peripheral blood (white blood cells x Eosinophils / 100).
Timepoint [4] 425250 0
This outcome will be measured via a blood draw through an external pathology lab, undertaken at screening, and at weeks 4, 8 and 12 post-baseline.
Secondary outcome [5] 425257 0
This safety outcome will be measured using liver function test (LFTs) changes via pathology (blood draw),
Timepoint [5] 425257 0
The test will be conducted by an external pathology lab using a participant blood sample, which will be collected at screening and weeks 4, 8 and 12 post-baseline.
Secondary outcome [6] 425258 0
This safety outcome will be measured using kidney function test changes via pathology (blood draw),
Timepoint [6] 425258 0
The test will be conducted by an external pathology lab using a participant blood sample, which will be collected at screening and weeks 4, 8 and 12 post-baseline.
Secondary outcome [7] 425259 0
Severity of EoE-related symptoms will be measured using a Visual Analogue Scale (VAS) from 0 (free of any symptoms) to 10 (worst symptoms ever had) will also be self-administered by participants.
Timepoint [7] 425259 0
A VAS will be self-administered by participants at weeks 0, 4, 8, and 12 post-baseline.

Eligibility
Key inclusion criteria
1. Adults aged 18 years and over.
2. Living in any state or territory of Australia.
3. Received a diagnosis of EoE confirmed by endoscopy and biopsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other oesophageal disorders unrelated to EoE.
2. Non-EoE related dysphagia.
3. Pregnant or breast-feeding women.
4. Does not speak or understand English to make an informed decision to join the trial.
5. Any liver enzyme greater than or equal to 2.0-fold the upper limit of normal (ULN).
6. History of, or currently experiencing liver damage/injury/problems as deemed clinically significant.
7. History of a blood clotting disorder or currently taking anti-coagulant medication (e.g., Warfarin, Dabigatran etc).
8. Acute disease (i.e., a rapid-onset disease or disorder that lasts a short time, and is accompanied by distinct, often intense symptoms).
9. Undergoing current chemotherapy, radiation, or other acute treatment for a major disease.
10. Unmanaged chronic disease not associated with EoE.
11. Between initial and second COVID-19 vaccinations.
12. Received any vaccination(s) less than 14 days prior to the enrolment visit, or have experienced any severe side effect/s after the vaccination.
13. Known allergy to the intervention (turmeric), or its excipients (sunflower, leucine, colloidal anhydrous silica, hypromellose, lecithin, microcrystalline cellulose, or silicified microcrystalline cellulose).

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)
To ensure all investigators are blinded to treatment allocation (i.e., before randomisation), an statistician who is external to the research team will generate the allocation sequence and enter it into the computer data management system (REDCap). The statistician will be the only person with access to the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An external statistician will generate the allocation sequence and enter it into the computer data management system. The statistician will be the only person with access to the randomisation sequence. Once the participant is formally enrolled in the study, the researcher will enter the participant’s information into an online database, for randomisation purposes. Once the data are entered, the participant will be randomised to a study arm via the inbuilt randomiser. The system will generate a participant number, which will be allocated to an intervention - either “Group A” (Meriva® 1000 mg per day) or “Group B” (Meriva® 2000 mg per day). These labels will align with the allocated participant number on the intervention label. This process will ensure the researcher is not able to influence the treatment assignment process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Open-labelled, randomised, dose comparison, pilot feasibility trial with two parallel arms
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed using IBM SPSS v28.0.1.1. Analyses will be conducted on an intention-to-treat basis, with per protocol analyses undertaken for hypothesis generating purposes only. Descriptive statistics will summarise data and be presented as either means and standard deviations or medians with interquartile ranges for continuous data, or absolute and relative frequencies for categorical data. Paired T tests, RM-ANOVA or Linear mixed-effects models will be used to estimate the intervention effects for EoE-HRQoL-A, BEDQ, VAS and AEC.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/10/2023
Actual
Date of last participant enrolment
Anticipated
24/11/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314302 0
Charities/Societies/Foundations
Name [1] 314302 0
ausEE Inc
Country [1] 314302 0
Australia
Funding source category [2] 314546 0
Commercial sector/Industry
Name [2] 314546 0
RN Labs Pty Ltd
Country [2] 314546 0
Australia
Primary sponsor type
University
Name
Southern Cross University, National Centre for Naturopathic Medicine
Address
Southern Cross UniversityMilitary Rd, East Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 316502 0
None
Name [1] 316502 0
Address [1] 316502 0
Country [1] 316502 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313414 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 313414 0
Ethics committee country [1] 313414 0
Australia
Date submitted for ethics approval [1] 313414 0
05/06/2023
Approval date [1] 313414 0
09/08/2023
Ethics approval number [1] 313414 0
2023/155

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

Contacts
Principal investigator
Name 128074 0
A/Prof Matthew Leach
Address 128074 0
Southern Cross University, Military Rd, East Lismore NSW 2480
Country 128074 0
Australia
Phone 128074 0
+61 266203298
Fax 128074 0
Email 128074 0
matthew.leach@scu.edu.au
Contact person for public queries
Name 128075 0
Nicole Hannan
Address 128075 0
Southern Cross University, Military Rd, East Lismore NSW 2480
Country 128075 0
Australia
Phone 128075 0
+61 411439331
Fax 128075 0
Email 128075 0
n.hannan.25@student.scu.edu.au
Contact person for scientific queries
Name 128076 0
Nicole Hannan
Address 128076 0
Southern Cross University, Military Rd, East Lismore NSW 2480
Country 128076 0
Australia
Phone 128076 0
+61 411439331
Fax 128076 0
Email 128076 0
n.hannan.25@student.scu.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
No IPD will be made public. All data will be presented as cumulative results.


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
No additional documents have been identified.