ANZCTR - Registration

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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]

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

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Alternative and Complementary Medicine

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Week 8

Secondary outcome [1]

Average change in generalised gastrointestinal symptoms from baseline as measured by the Gastrointestinal Symptom Rating Scale

Timepoint [1]

Baseline, Week 4, Week 8, Week 12

Secondary outcome [2]

Proportion of complete cases who report “adequate relief” at Week 12 as measured by the IBS-Adequate Relief instrument

Timepoint [2]

Baseline, Week 4, Week 8, Week 12

Secondary outcome [3]

Average change in quality of life from baseline as measured by the IBS-Quality of Life scale.

Timepoint [3]

Baseline, Week 4, Week 8, Week 12

Secondary outcome [4]

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]

Week 12

Secondary outcome [5]

Total number of Adverse Events and Serious Adverse Events reported using NIH’s Common Terminology Criteria for Adverse Events version 4.0

Timepoint [5]

Week 4, Week8, Week 12

Secondary outcome [6]

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]

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?

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]

4006 - Fortitude Valley

Recruitment postcode(s) [2]

3000 - Melbourne

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Ontario; British Columbia

Country [2]

United States of America

State/province [2]

Washington; California; Illinois; Arizona

Country [3]

New Zealand

State/province [3]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Endeavour College of Natural Health

Address [1]

Level 2, 269 Wickham St Fortitude Valley QLD 4006

Country [1]

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]

Individual

Name [1]

Dr Joshua Goldenberg

Address [1]

Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028

Country [1]

United States of America

Other collaborator category [1]

Individual

Name [1]

Dr Kieran Cooley

Address [1]

Canadian College of Naturopathic Medicine, 1255 Sheppard Ave E, North York, ON M2K 1E2

Country [1]

Canada

Other collaborator category [2]

Individual

Name [2]

Andrew Day

Address [2]

Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028

Country [2]

United States of America

Other collaborator category [3]

Individual

Name [3]

Melissa Collins

Address [3]

Endeavour College of Natural Health, 368 Elizabeth St, Melbourne VIC 3000

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Christine Yap

Address [4]

Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028

Country [4]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bastyr University Institutional Review Board

Ethics committee address [1]

Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028, USA

Ethics committee country [1]

United States of America

Date submitted for ethics approval [1]

04/09/2017

Approval date [1]

28/09/2017

Ethics approval number [1]

IRB 17-1597

Ethics committee name [2]

Endeavour College of Natural Health Human Research Ethics Committee

Ethics committee address [2]

Level 2, 269 Wickham St, Fortitude Valley, QLD 4006

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

10/11/2017

Approval date [2]

Ethics approval number [2]

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

Dr Joshua Goldenberg

Address

Bastyr University, 14500 Juanita Dr NE, Kenmore, WA 98028, USA

Country

United States of America

Phone

+1719377609

Fax

[email protected]

Contact person for public queries

Name

Amie Steel

Address

Endeavour College of Natural Health, Level 2, 269 Wickham St Fortitude Valley QLD 4006

Country

Australia

Phone

+61 7 3253 9523

Fax

[email protected]

Contact person for scientific queries

Name

Amie Steel

Address

Endeavour College of Natural Health, Level 2, 269 Wickham St Fortitude Valley QLD 4006

Country

Australia

Phone

+61 7 3253 9523

Fax

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics.	2018	https://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.

Trial Review

Documents added manually

Documents added automatically