ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000911190

Ethics application status

Approved

Date submitted

6/06/2019

Date registered

28/06/2019

Date last updated

17/11/2020

Date data sharing statement initially provided

28/06/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Australian Inflammatory Bowel Disease Microbiome Study - The AIM Study

Scientific title

Defining the Australian Inflammatory Bowel Disease Microbiome Study - The AIM Study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1234-7516

Trial acronym

AIM

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

Inflammatory Bowel Disease

ulcerative colitis

colitis

Crohn's disease

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Oral and Gastrointestinal

Crohn's disease

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Patients with Inflammatory Bowel Disease

Male and female (nonpregnant) patients with either ulcerative colitis or Crohn's disease undergoing follow-up colonoscopy for disease activity assessment will have samples of large bowel mucosa, peripheral blood, urine and stool collected at colonoscopy (stool and urine collection tubes/instructions will be provided in advance, so patients can bring samples to their colonoscopy appointment).

IBD patients who are eligible for the study but are not requiring colonoscopy, will be invited to participate in the study by local research teams either at the current clinic visit, a future scheduled clinic visit or a separate visit to the local clinical research facility. At this appointment, peripheral blood, urine oral swab and stool will be collected (stool and urine collection tubes/instructions will be provided in advance, so patients can bring samples to their appointment).

All IBD patients will be asked to complete a series of validated questionnaires detailing patient reported outcomes/environmental exposures as well as dietary habits. Completion of the questionnaires will be requested at study entry and at the end of 12 and 24 months. A limited patient reported measure of disease activity will also be requested alongside 3 monthly stool sampling.

To allow further detailed analyses of the gut microbiota, patients will be asked to provide oral swab and stool samples, for microbiota analysis and measurement of host protein levels including faecal calprotectin, every 3 months for 24 months.

In the event that patients experience an increase in symptoms, they will be advised to contact their IBD clinical team as per usual clinical management, but they will be requested to provide additional oral swab and stool samples during the episode of flare (defined by a standardised clinical definition), in addition to the 3-monthly regular request.

Sample and Data Collection

For participants undergoing colonoscopies, up to six additional intestinal tissue samples will be collected along with the biopsy samples that are routinely taken during this procedure for clinical management. Approximately 20ml of blood (4 teaspoons) will also be collected along with the blood tests that are routinely taken at this time. In addition, patients will be asked to provide a urine sample (50 ml) in individual sterile collection tubes, an oral swab, and a stool sample will be collected by the participant before commencing bowel preparation the previous night (collection kit/instructions provided in advance).

For participants attending IBD outpatient clinics or participants attending a clinical research facility, 30ml of blood (6 teaspoons), 50 mL of urine, oral swab, and a stool sample will be collected when they initially enter the study. At subsequent appointments if participants are having blood collected as part of routine clinical management, we will collect an additional sample.

Questionnaires
Participants will be asked to fill in a Food Frequency Questionnaire and a food avoidance questionnaire online in one of their visits to the clinic (or they can be given a user login and password to fill in the questionnaire at home). These questionnaires are aiming to evaluate the participants’ usual eating and drinking habits over the last 12 months (e.g. What type of spread or oil did you usually put on your bread? with the following answers to select from: none, butter, butter-margarine blends [e.g. Devondale Extra Soft or Dairy Soft, Western Star spreadable varieties], margarine, olive oil).

Participants will be asked to record every food item they eat in a specialised smartphone application for 5 days (4-week days and 1 weekend day, not necessarily consecutive). If they are not smartphone users, they will be provided with a 5-day diet diary which they will be asked to fill in and return in their next visit to the clinic. Participants will complete this at study entry, at 12 and 24 months.

All participants will also complete a limited participant reported outcomes measures score which will be returned with their 3 monthly stool and oral samples.

Participants will also be asked to complete a lifestyle factor questionnaire during their visits to the clinic (or they can be given a user login and password to fill in the questionnaire at home). This lifestyle questionnaire is aiming to evaluate the participants’ usual lifestyle habits over the last 12 months (e.g. level of exercise, sleep habits, travel habits, use of health supplements and complementary medicines. A paper-based format will be available for participants who cannot complete it online. Participants will complete this at study entry, at 12 and 24 months.

For all participants in this study, the researchers may access their hospital records for demographic and/or clinical information solely for the purposes of this study.

Intervention code [1]

Not applicable

Comparator / control treatment

Population controls
(Nonpregnant) partner/spouse and family members of case participants will be invited to participate in the study as controls by local research teams when they accompany their IBD affected family member to clinic appointments. Population controls will be recruited through publicity and word of mouth and recruited at clinical research facilities in specific AIM study clinics. Upon consent, peripheral blood, urine, oral swab and stool will be collected in the same manner as IBD patients, (stool and urine collection tubes/instructions will be provided in advance, so participants can bring samples to their next follow-up appointment).

All healthy controls will be asked to complete a series of validated questionnaires detailing participant reported outcomes/environmental exposures and dietary habits. Completion of the questionnaire will be requested at study entry and at the end of 12 and 24 months.

To allow further detailed analyses of the gut microbiota, participants will be asked to provide oral swab and stool samples, for microbiota analysis and measurement of host protein levels including faecal calprotectin, every 3 months for 24 months. Participants will be asked to self-collect samples at home (following previously provided instructions) and return to the central processing lab (MRC at St George Hospital) in postage paid envelopes. A limited participant reported measure of wellness will also be requested alongside 3 monthly stool sampling.

Sample and Data Collection

For participants undergoing any incidental colonoscopy procedures, up to six additional intestinal tissue samples will be collected along with the biopsy samples that are routinely taken during this procedure for clinical management. Participants do not require colonoscopy as part of the AIM study.
Approximately 20ml of blood (4 teaspoons) will also be collected along with the blood tests that are routinely taken at this time. In addition, patients will be asked to provide a urine sample (50 ml) in individual sterile collection tubes, an oral swab, and a stool sample will be collected by the participant before commencing bowel preparation the previous night (collection kit/instructions provided in advance).

When attending the clinical research facility, 30ml of blood (6 teaspoons), 50 mL of urine, oral swab, and a stool sample will be collected when they initially enter the study. At subsequent appointments if participants are having blood collected as part of routine clinical management, we will collect an additional sample.

Questionnaires
Participants will be asked to fill in a Food Frequency Questionnaire and a food avoidance questionnaire online in one of their visits to the clinic (or they can be given a user login and password to fill in the questionnaire at home). These questionnaires are aiming to evaluate the participants’ usual eating and drinking habits over the last 12 months (e.g. What type of spread or oil did you usually put on your bread? with the following answers to select from: none, butter, butter-margarine blends [e.g. Devondale Extra Soft or Dairy Soft, Western Star spreadable varieties], margarine, olive oil).

Participants will be asked to record every food item they eat in a specialised smartphone application for 5 days (4-week days and 1 weekend day, not necessarily consecutive). If they are not smartphone users, they will be provided with a 5-day diet diary which they will be asked to fill in and return in their next visit to the clinic. Participants will complete this at study entry, at 12 and 24 months.

All participants will also complete a limited participant reported outcomes measures score which will be returned with their 3 monthly stool and oral samples.

Participants will also be asked to complete a lifestyle factor questionnaire during their visits to the clinic (or they can be given a user login and password to fill in the questionnaire at home). This lifestyle questionnaire is aiming to evaluate the participants’ usual lifestyle habits over the last 12 months (e.g. level of exercise, sleep habits, travel habits, use of health supplements and complementary medicines. A paper-based format will be available for participants who cannot complete it online. Participants will complete this at study entry, at 12 and 24 months.

For all participants in this study, the researchers may access their hospital records for demographic and/or clinical information solely for the purposes of this study.

Control group

Active

Outcomes

Primary outcome [1]

• To define the difference in alpha-diversity measurements in gut microbiota composition between IBD and control participant stool samples

Timepoint [1]