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Trial registered on ANZCTR


Registration number
ACTRN12617001413314
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
5/10/2017
Date last updated
17/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Naturopathic Approaches to the treatment of Irritable Bowel Syndrome
Scientific title
Prospective Observational Study to evaluate proportion of responders to Naturopathic Approaches to Irritable Bowel Syndrome in Academic Teaching Clinics
Secondary ID [1] 292866 0
None known
Universal Trial Number (UTN)
U1111-1201-9584
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 304712 0
Condition category
Condition code
Oral and Gastrointestinal 304020 304020 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 304292 304292 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Consultations with and treatment from a naturopathic student in a supervised clinical environment as part of an existing academic clinic. Participants will consult with a naturopathic student engaged in supervised clinical practicum as part of their naturopathic training. Student naturopaths will follow regular clinical process: full case history, individualised treatment plan development; input and advice from a qualified naturopathic doctor to finalise treatment plan; and discussion of treatment plan with participant, including treatment recommendations and prescriptions as appropriate. Each student naturopath will conduct their consultation in accordance with the legislation, policies, systems and processes appropriate to their country, region and institution. As such, this study will document treatment as it occurs in natural practice, at the discretion of the practitioner. The observation period will last for 12 weeks for each participant.
Intervention code [1] 299109 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303354 0
Our a priori primary outcome is the proportion of IBS-SSS responders at week eight which we define as the proportion of complete cases who achieve a 50 or greater point improvement in their baseline to week eight IBS-SSS score
Timepoint [1] 303354 0
Week 8
Secondary outcome [1] 338727 0
Average change in generalised gastrointestinal symptoms from baseline as measured by the Gastrointestinal Symptom Rating Scale
Timepoint [1] 338727 0
Baseline, Week 4, Week 8, Week 12
Secondary outcome [2] 339370 0
Proportion of complete cases who report “adequate relief” at Week 12 as measured by the IBS-Adequate Relief instrument
Timepoint [2] 339370 0
Baseline, Week 4, Week 8, Week 12
Secondary outcome [3] 339371 0
Average change in quality of life from baseline as measured by the IBS-Quality of Life scale.
Timepoint [3] 339371 0
Baseline, Week 4, Week 8, Week 12
Secondary outcome [4] 342078 0
Assessment of patients' Lived Experience during naturopathic care via qualitative interviews to limited number of participants within two weeks' of the study completion
Timepoint [4] 342078 0
Week 12
Secondary outcome [5] 342079 0
Total number of Adverse Events and Serious Adverse Events reported using NIH’s Common Terminology Criteria for Adverse Events version 4.0
Timepoint [5] 342079 0
Week 4, Week8, Week 12
Secondary outcome [6] 342080 0
A measure of Treatment Description implementing the CARE measure, a 10-item validated instrument designed to evaluate patient experiences of practitioner empathy, the 5-item Empowerment scale and the documentation of patient charts
Timepoint [6] 342080 0
Week 12

Eligibility
Key inclusion criteria
Eligible participants are adults (18 years of age or older) who present to one of the participating naturopathic academic teaching clinics with a diagnosis of IBS (either preexisting or diagnosed by the naturopathic physician) which was a primary cause of the visit (listed within the top 3 diagnoses for the visit and addressed in the visit plan).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Due to the naturalistic observational design, the only exclusion criteria will be that participants must have competent English skills to be able to understand and fill out the assessment forms and be over 18 years of age

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
In this uncontrolled study, before and after differences between baseline and endpoint values will be calculated. The eight week endpoint will be the primary endpoint of the study. P values will be set at 0.05. As a pilot study, sample size will be set to as many participants as can be enrolled within a one year period.

Outcome data will be presented in descriptive and summary form. Secondary analyses will be conducted by country of care, IBS diagnosis status, naturopathic medicine as adjunctive versus sole care, adherence (as determined by patient reported compliance), and severity of baseline condition (as determined by the baseline IBS-SSS score).

Our primary analysis will describe outcomes as a complete case analysis i.e. only including those participants for whom we have no missing outcome data. We will also conduct a sensitivity analysis for our primary outcome using the last observation carried forward for missing values.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment postcode(s) [1] 17490 0
3000 - Melbourne
Recruitment postcode(s) [2] 17489 0
4006 - Fortitude Valley
Recruitment outside Australia
Country [1] 9199 0
Canada
State/province [1] 9199 0
Ontario; British Columbia
Country [2] 9200 0
United States of America
State/province [2] 9200 0
Washington; California; Illinois; Arizona
Country [3] 9201 0
New Zealand
State/province [3] 9201 0
Auckland

Funding & Sponsors
Funding source category [1] 297495 0
University
Name [1] 297495 0
Endeavour College of Natural Health
Country [1] 297495 0
Australia
Primary sponsor type
Individual
Name
Dr Amie Steel
Address
Endeavour College of Natural Health
Level 2, 269 Wickham St Fortitude Valley QLD 4006
Country
Australia
Secondary sponsor category [1] 296500 0
Individual
Name [1] 296500 0
Dr Joshua Goldenberg
Address [1] 296500 0
Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028
Country [1] 296500 0
United States of America
Other collaborator category [1] 279726 0
Individual
Name [1] 279726 0
Dr Kieran Cooley
Address [1] 279726 0
Canadian College of Naturopathic Medicine, 1255 Sheppard Ave E, North York, ON M2K 1E2
Country [1] 279726 0
Canada
Other collaborator category [2] 279727 0
Individual
Name [2] 279727 0
Andrew Day
Address [2] 279727 0
Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028
Country [2] 279727 0
United States of America
Other collaborator category [3] 279728 0
Individual
Name [3] 279728 0
Melissa Collins
Address [3] 279728 0
Endeavour College of Natural Health, 368 Elizabeth St, Melbourne VIC 3000
Country [3] 279728 0
Australia
Other collaborator category [4] 279729 0
Individual
Name [4] 279729 0
Christine Yap
Address [4] 279729 0
Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028
Country [4] 279729 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298594 0
Bastyr University Institutional Review Board
Ethics committee address [1] 298594 0
Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028, USA
Ethics committee country [1] 298594 0
United States of America
Date submitted for ethics approval [1] 298594 0
04/09/2017
Approval date [1] 298594 0
28/09/2017
Ethics approval number [1] 298594 0
IRB 17-1597
Ethics committee name [2] 298595 0
Endeavour College of Natural Health Human Research Ethics Committee
Ethics committee address [2] 298595 0
Level 2, 269 Wickham St, Fortitude Valley, QLD 4006
Ethics committee country [2] 298595 0
Australia
Date submitted for ethics approval [2] 298595 0
10/11/2017
Approval date [2] 298595 0
Ethics approval number [2] 298595 0

Summary
Brief summary
We aim to conduct an international prospective observational before and after study on naturopathic approaches to IBS. This will allow us to better describe naturopathic approaches to this disorder, establish the feasibility of building an international consortium of academic naturopathic clinics as well as the feasibility of recruiting participants. Our ultimate goal is to follow this observational study with a randomized active controlled trial using the same consortium and benefiting from lessons learned during this study.

Our primary aims are descriptive. We aim to describe naturopathic approaches to IBS as well as establish pilot data on before and after changes in validated IBS instruments. Secondary aims include the feasibility of recruitment and operations across more than 9 sites in 4 countries; the establishment of an international research network of naturopathic teaching clinics; qualitative data gathering around the experience of patients seeking naturopathic care for IBS; and comparing the consensus results of our delphi panel of naturopathic IBS experts to the care received at the teaching clinics.
Trial website
Trial related presentations / publications
Steel A, Goldenberg J, Cooley C (2017) Establishing an international research collaborative for naturopathy: the International Research Consortium of Naturopathic Academic Clinics. Advances in Integrative Medicine (In Press)
Public notes

Contacts
Principal investigator
Name 77598 0
Dr Joshua Goldenberg
Address 77598 0
Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028, USA
Country 77598 0
United States of America
Phone 77598 0
+1719377609
Fax 77598 0
Email 77598 0
joshua.z.goldenberg@gmail.com
Contact person for public queries
Name 77599 0
Amie Steel
Address 77599 0
Endeavour College of Natural Health, Level 2, 269 Wickham St Fortitude Valley QLD 4006
Country 77599 0
Australia
Phone 77599 0
+61 7 3253 9523
Fax 77599 0
Email 77599 0
amie.steel@endeavour.edu.au
Contact person for scientific queries
Name 77600 0
Amie Steel
Address 77600 0
Endeavour College of Natural Health, Level 2, 269 Wickham St Fortitude Valley QLD 4006
Country 77600 0
Australia
Phone 77600 0
+61 7 3253 9523
Fax 77600 0
Email 77600 0
amie.steel@endeavour.edu.au

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
EmbaseNaturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics.2018https://dx.doi.org/10.1016/j.imr.2018.06.001
N.B. These documents automatically identified may not have been verified by the study sponsor.