Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000643572p
Ethics application status
Submitted, not yet approved
Date submitted
4/04/2024
Date registered
20/05/2024
Date last updated
20/05/2024
Date data sharing statement initially provided
20/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Dietary Histamine in Chronic Pain – Pilot Study
Scientific title
Assessing the impact of an exogenous histamine-reducing dietary intervention on pain as measured by the Brief Pain Inventory (BPI) in adults.
Secondary ID [1] 311885 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 333463 0
Condition category
Condition code
Anaesthesiology 330130 330130 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4-week low histamine diet that will require participants to avoid eating foods that are naturally high in histamine (e.g., tomato, eggplant, olives, spinach), as well as foods, fluids and food additives that can release histamines into the body. When enrolling onto the study, participants will be provided with a 'Diet Information Sheet' that has been developed by Dietitians and a clinician specialising in histamine intolerance. This sheet contains detailed information about foods that participants can and can't eat. Participants will discuss the diet with the study Dietitian, and also complete the baseline survey during this initial 90-minute introductory session, Participants will then meet with a study Dietitian at the end of every week for 4-weeks, either in-person or via Zoom for a 60-minute appointment to discuss the diet and any questions they might have. The last of these 4 weekly appointments will be approximately 90-minutes as the participants will also complete the follow-up survey. Dietary adherence will be tracked by a study Dietitian at the weekly 60-minute dietetics sessions with a food symptom diary and a compliance survey.
Intervention code [1] 328350 0
Lifestyle
Intervention code [2] 328413 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337884 0
Change in pain
Timepoint [1] 337884 0
Baseline and 4 weeks post commencement of dietary intervention
Secondary outcome [1] 433598 0
Change in quality of life outcome
Timepoint [1] 433598 0
Baseline and 4 weeks post commencement of dietary intervention
Secondary outcome [2] 433599 0
Depression
Timepoint [2] 433599 0
Baseline and 4 weeks post commencement of dietary intervention

Eligibility
Key inclusion criteria
(a)All patients aged 18 years and over referred to Pain Management Research Centre at Royal North Shore Hospital
(b) Adults (age 18 years and over)
(c) Patient-reported food allergy or intolerance and/or GI pain, discomfort, or bloating, and
(d) Multi-site pain (2 or more sites), and
(e) Chronic pain (at least 3 months)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Any active cancer
(b) Inability to read or speak English sufficiently
(c) Patients seeking further medical/ surgical interventions for pain

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)
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will compare pain scores on the 4-item pain severity subsection of the Brief Pain Inventory (BPI) pre and post dietary intervention using paired samples t-test. Similar analysis using paired t-test will be conducted to analyse secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26373 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 42345 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 316233 0
University
Name [1] 316233 0
GenIMPACT, Macquarie University
Country [1] 316233 0
Australia
Primary sponsor type
University
Name
GenIMPACT, Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 318422 0
None
Name [1] 318422 0
Address [1] 318422 0
Country [1] 318422 0
Other collaborator category [1] 283000 0
Hospital
Name [1] 283000 0
PMRC - Pain Management Research Centre
Address [1] 283000 0
Country [1] 283000 0
Australia
Other collaborator category [2] 283001 0
Hospital
Name [2] 283001 0
Royal North Shore Hospital
Address [2] 283001 0
Country [2] 283001 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315056 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315056 0
Ethics committee country [1] 315056 0
Australia
Date submitted for ethics approval [1] 315056 0
22/02/2024
Approval date [1] 315056 0
Ethics approval number [1] 315056 0

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

Contacts
Principal investigator
Name 133526 0
Prof Deborah Schofield
Address 133526 0
GenIMPACT, Macquarie University, 4 Eastern Road, Sydney, NSW 2019
Country 133526 0
Australia
Phone 133526 0
+61403399464
Fax 133526 0
Email 133526 0
[email protected]
Contact person for public queries
Name 133527 0
Philippa Smith
Address 133527 0
GenIMPACT, Macquarie University, 4 Eastern Road, Sydney, NSW 2019
Country 133527 0
Australia
Phone 133527 0
+61298504882
Fax 133527 0
Email 133527 0
[email protected]
Contact person for scientific queries
Name 133528 0
Deborah Schofield
Address 133528 0
GenIMPACT, Macquarie University, 4 Eastern Road, Sydney, NSW 2019
Country 133528 0
Australia
Phone 133528 0
+61298504882
Fax 133528 0
Email 133528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.