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Trial registered on ANZCTR

Registration number

ACTRN12616001162404

Ethics application status

Approved

Date submitted

22/08/2016

Date registered

26/08/2016

Date last updated

9/04/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparing clinical symptoms and bacterial features in irritable bowel syndrome (IBS) patients with and without small intestine bacterial overgrowth (SIBO).

Scientific title

Comparing clinical symptoms and features of the microbiome and metabolome in diarrhoea predominant and mixed irritable bowel syndrome (IBS) patients with and without small intestine bacterial overgrowth (SIBO).

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1186-5261

Trial acronym

Linked study record

ACTRN12616001149459

Health condition

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

Irritable bowel syndrome (IBS)

Condition category

Condition code

Oral and Gastrointestinal

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

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Participants will be screened for small intestine bacterial overgrowth (SIBO) using a glucose breath test. Before consuming a 75g of glucose in 200ml of water the participants will provide a breath sample. They will then provide breath samples every 15 minutes for 2 hours. If they have a rise of >=12 ppm of either hydrogen or methane from baseline this will be diagnosed as SIBO.

Participants will be seen for one 2 hour session with no follow for those without SIBO. Those with SIBO will be part of the associated randomised control trial.

Intervention code [1]

Not applicable

Comparator / control treatment

Participants with no evidence of SIBO and healthy controls.

Control group

Active

Outcomes

Primary outcome [1]

Comparing symptom severity as measured on the IBS symptom severity scoring system (Francis 1997) between those with and without small intestine bacterial overgrowth.

Timepoint [1]

Baseline

Secondary outcome [1]

Comparing IBS related quality of life (Patrick 1998) between those with and without small intestine bacterial overgrowth.

Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Digestive diseases and sciences. 1998;43(2):400-11.

Timepoint [1]

Baseline

Secondary outcome [2]

Comparing nutritional intake of IBS patients with and without small intestine bacteria overgrowth and healthy controls (Diet history questionnaire version 2)

Timepoint [2]

Baseline

Secondary outcome [3]

Comparing the colonic microbiome of IBS patients with and without small intestine bacteria overgrowth and healthy controls. Stool samples will be stored at -80C until the DNA is extracted. DNA will be extracted using the powersoil kit. The V4 region of the 16 S rRNA gene will be amplified. DNA will be sequenced on the Ilumina platform. Data will be analysed using compositional data (CoDa) approaches (Gloor 2016) on R statistical programme. Specifically the ALDEx2 package will be used. Data will be presented as bi-plots, bar charts, dendograms and heat maps as appropriate.

Timepoint [3]

Baseline

Secondary outcome [4]

Comparing the metabolome of IBS patients with and without small intestine bacterial overgrowth and healthy controls. Urine samples will be stored at -80C until analysis is undertaken. Liquid chromatograpy (LC/MS) and gas chromatography (GC/MS) will be used to identify small molecules present. Data will be analysed using compositional data (CoDa) approaches (Gloor 2016) on R statistical programme. Specifically the ALDEx2 package will be used. Data will be presented as bi-plots, bar charts, dendograms and heat maps as appropriate.

Timepoint [4]

Baseline

Eligibility

Key inclusion criteria

Participants with IBS (D) or IBS (M) according to Rome III criteria who are fluent in English. Healthy controls are female and male, aged 18-65 with no gastrointestinal physiology and fluent in English.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Organic gastrointestinal disease (e.g. coeliac, IBD),
Diabetes,
Serious neurological or respiratory conditions
Previous gastrointestinal surgery (except appendectomy),
Pancreatitis,
Previous radiotherapy to the abdominal area or chemotherapy,
Pregnancy and lactation,
Antibiotics or probiotics within the last 6 weeks,

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

For the clinical trial we calculated that 66 participants were required. For the power calculation it was decided that a difference of 100 points on the IBS Symptom Severity Scoring System (IBS SS) would be a strong measure of clinical significance. This was based on the original paper describing the development of the IBS SS by Francis (1997). In this paper the mean for those with mild IBS was 133 (s.d 25), moderate was 243 (s.d 33) and severe 372 (s.d 66). Current did not attend rates for a dietetic service are approximately 20% and this figure was used as a proxy for likely drop outs. An alpha (p value) of 0.05 was selected with 80% power. It was calculated based on these numbers that 33 participants would be needed in each group. Approximately 1 in 4-5 people with IBS have SIBO when using the glucose breath test as a substrate for the test. Therefore to get 66 participants for the intervention we are likely to need to screen about 300.

For continuous variables in the symptom severity scoring system and the quality of life questionnaire students' ttests will be used to compare those with and without small intestine bacteria overgrowth. For categorical variables on the symptom severity scoring system chi squared tests will be used.

Student ttests will be used to compare nutrient intake between the two groups (from the diet history questionnaire.)

The microbiome and metabolomics data will be analysed using compositional data (CoDa) analysis methods (Gloor Ann Epidemiol. 2016;26(5):322-9.). This analysis will be done on the R statistics platform. Data will be presented in compositional biplots, bar charts of abundance, phylogenetic trees and heatmaps as appropriate

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

The study co-ordinator had to return to New Zealand.

Date of first participant enrolment

Anticipated

Actual

19/04/2016

Date of last participant enrolment

Anticipated

29/09/2017

Actual

1/06/2017

Date of last data collection

Anticipated

13/08/2017

Actual

1/09/2017

Sample size

Target

220

Accrual to date

Final

114

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Dunedin School of Medicine
First Floor, Dunedin Hospital
Great King Street
Dunedin 9016

Country [1]

New Zealand

Primary sponsor type

University

Name

Dunedin School of Medicine, University of Otago

Address

First Floor, Dunedin Hospital
Great King Street
Dunedin 9016

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

GutHealthNetwork, University of Otago

Address [1]

Department of Medicine,
9th Floor, Dunedin Hospital
Great King Street
Dunedin 9016

Country [1]

New Zealand

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

NZ Society of Gastroenterology

Address [2]

NZSG Secretariat
NZ Society of Gastroenterologist Secreriat
Anna Pears
4th Floor, RACP College Office
99 The Terrace
PO Box 10-601
Wellington 6143

Country [2]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Adam Rahman

Address [1]

St Joseph's Health Care London
268 Grosvenor St
London
Ontario
N6A 4V2

Country [1]

Canada

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western University Health Science Research Ethics Board

Ethics committee address [1]

Western University
Research Support Services Building Rm 5150
1393 Western Rd
London 
Ontario
N6G 1G9

Ethics committee country [1]

Canada

Date submitted for ethics approval [1]

11/11/2015

Approval date [1]

27/11/2015

Ethics approval number [1]

Summary

Brief summary

The data for this observational study comparing the clinical characteristics and features of the microbiome is being collected at the screening phase of ACTRN12616001149459

In 371306 participants with diarrhoea predominant IBS and mixed type IBS are being screened for small intestine bacterial overgrowth (SIBO). 75g of glucose in 200ml of water is being provided as the test substrate. Prior to adminisitration of the glucose solution and every 15 minutes after consuming the test substrate for 2 hours participants are providing a breath sample. The breath sample is being analysed for hydrogen and methane. For participants with a rise of => than 12 ppm in either gas from baseline are defined as haing SIBO.

In this observational study we are aiming to see whether there is a diference in clinical characteristics and microbiome features between those with and without SIBO. 

Our hypothesis is that the clinical characteristics of those with and without SIBO will differ. Secondly we hypothesise that there will be differences in the products produced by the bacteria (detected in the urinary metabolome).

Prior to attending the screening survey participants will complete 8 surveys on line and they will provide a stool and a urine sample. The questionnaires they will complete are a demographic questionnaire, a simple health questionnaire, the IBS symptom severity scoring system (Francis 1997), and IBS quality of life questionnaire (Drossman 1998). the physical activity adult questionnaire (Garriguet 2015), the hospital anxiety and depression index (Zigmond 1983) and a foods avoided questionnaire and the diet history questionnaire version 2 (http://epi.grants.cancer.gov/dhq2/).

Faecal and urine samples will be stored at -80C until they are analysed. Faecal samples will be analysed for the bacteria present (in the colon) and urine samples will be analysed to see what the bacteria have been doing.

Trial website

Not applicable

Trial related presentations / publications

None as yet

Public notes

Contacts

Principal investigator

Name

A/Prof Michael Schultz

Address

Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016

Country

New Zealand

Phone

+64 3 474 0999

Fax

michael.schultz@otago.ac.nz

Contact person for public queries

Name

Ruth Harvie

Address

c/- the Canadian centre for the human microbiome and probiotics
Lawson Research Institute
268 Grosvenor St
London
Ontario
N6A 4V2

Country

Canada

Phone

+1 519 317 2384

Fax

ruth.harvie@postgrad.otago.ac.nz

Contact person for scientific queries

Name

Michael Schultz

Address

Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016

Country

New Zealand

Phone

+64 3 474 0999

Fax

michael.schultz@otago.ac.nz

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

No additional documents have been identified.

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