ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000368538

Ethics application status

Approved

Date submitted

13/04/2015

Date registered

22/04/2015

Date last updated

10/12/2019

Date data sharing statement initially provided

6/03/2019

Date results provided

6/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Dietary fibre as a modulator of airway inflammation in asthma

Scientific title

A randomised crossover trial including clinically stable asthmatic adults to examine the effect of pre/probiotic supplements on short chain fatty acids (SCFA), airway inflammation and to study the mechanisms by which fibre exerts these effects.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1168-9055

Trial acronym

FAIM

Linked study record

Health condition

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

Asthma

Condition category

Condition code

Respiratory

Asthma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

There are two intervention arms and one placebo arm in this 3 way cross over study. Each subject will be randomly allocated to take each treatment/placebo arm in random order for 7 days each, with a 2 week wash out period in between each phase of the study.
1. Prebiotic (Frutafit (registered trademark) Inulin powder) (6 gram sachet twice daily) / Placebo capsule (once daily)
2. Prebiotic (Frutafit (registered trademark) Inulin powder) (6 gram sachet twice daily) / Probiotic capsule (Caruso's Alive Probiotic containing: Lactobacillus acidophilus 7.5 billion CFU, Lactobacillus rhamnosus 8.75 billion CFU, Bifidobacterium lactic 8.75 billion CFU) (once daily)
Subjects will be provided with 6 grams of Inulin in an individual sachet for each dose, to be mixed with water before meals twice daily (morning/evening). The probiotic provided is in capsule form and is to be taken once daily before breakfast. The placebo capsule is also to be taken once daily before breakfast.
Pill count back method and study diaries will be used to monitor adherence.
For 2 weeks prior to the first visit and for the duration of the study, participants will consume a fibre-controlled background diet. This will be achieved by avoidance of fibre-rich foods, limiting fruit and vegetable intake to 2 serves/ day and consuming 1/2 cup of All-Bran /day.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo (Maltodextrin powder) (6 gram sachet twice daily) / Placebo capsule (once daily) for 7 days.
The placebo powder (maltodextrin) will also be provided in 6 gram individual sachets for each dose, to be mixed with water before meals twice daily (morning/evening). The placebo capsule is also to be taken once daily before breakfast.

Control group

Placebo

Outcomes

Primary outcome [1]

Plasma short chain fatty acids (SCFA) will be measured before and after each phase of the study.

Timepoint [1]

Change in SCFA after 7 days of each treatment arm compared to placebo.

Secondary outcome [1]

Systemic Inflammation (Plasma CRP & TNFa)

Timepoint [1]

Change in Plasma CRP & TNFa after 7 days of each treatment arm compared to placebo.

Secondary outcome [2]

Airway Inflammation (sputum cell counts, IL-8, FeNO)

Timepoint [2]

Change in sputum cell counts, IL-8 and FeNO after 7 days of each treatment arm compared to placebo

Secondary outcome [3]

Faecal SCFA

Timepoint [3]

Change in faecal SCFA after 7 days of each treatment arm compared to placebo.

Eligibility

Key inclusion criteria

Doctor diagnosed stable asthma
Aged 18+ years
Males and Females
Never or ex-smokers (6 months minimum cessation)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Smoking, pregnant/breastfeeding, Asthma is not the primary respiratory diagnosis, Asthma exacerbation or respiratory tract infection (oral corticosteroids or antibiotics) in the past month, Any use of antibiotics in the past month, unable or unwilling to modify diet, diagnosed bowel disorders or intestinal disorders, dietary or nutritional supplement use within the previous 4 weeks, current use of any oral medication known to significantly influence inflammation (eg statins or NSAIDs). Subject has a clinically important medical illness (including serious psychological disorders) likely to interfere with management or participation in the study

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

After eligibility is confirmed through screening visit, subjects will be given a unique study number and randomisation number which will determine the order in which they receive the three study interventions.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation sequence will be determined by an independent statistician using computer generated codes in a 3by3 latin square method.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Crossover

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Mean levels of difference in outcomes will be tested using repeated-measurements ANOVA of period differences by treatment sequence, which provides an estimate of treatment effect independent of period effect (Senn, 2002). An independent ANOVA of period totals by treatment sequence will test the assumption of no carry over effects.
Based on previous studies (Tarini and Wolever, 2010), we hypothesise that we will observe a change in plasma acetate of ~1SD. To achieve 90% power to detect a difference between groups, using alpha=0.025 (to avoid type 1 error when comparing 3 groups), we need n=15 subjects. Allowing for 30% dropouts, we will recruit n=20 subjects.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2015

Actual

22/06/2015

Date of last participant enrolment

Anticipated

Actual

5/11/2015

Date of last data collection

Anticipated

Actual

26/02/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2305 - New Lambton Heights

Recruitment postcode(s) [2]

2300 - Newcastle

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

John Hunter Hospital Charitable Trust

Address [1]

Lookout Rd, New Lambton Heights, 2305, NSW

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Lisa Wood

Address

The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Bronwyn Berthon

Address [1]

The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

The University of Newcastle

Address [2]

University Drive, Callaghan, 2308, NSW

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Research Ethics and Governance Unit
Locked bag 1, New Lambton, NSW, 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/02/2015

Approval date [1]

01/04/2015

Ethics approval number [1]

15/03/18/3.03

Summary

Brief summary

The purpose of this project is to investigate whether a soluble fibre supplement alone or in combination with a probiotic is able to reduce inflammation in adults with asthma. Once ingested orally, soluble fibre- a normal component of the diet- acts as a prebiotic and is digested by healthy gut bacteria to produce short chain fatty acids (SCFAs).  These SCFAs may be beneficial in reducing airway inflammation in asthma. Supplementing with healthy bacteria using a probiotic may also increase the production of SCFAs.  The project involves a nine week intervention where 20 subjects with stable asthma will be allocated to take the prebiotic alone, prebiotic with probiotic and placebo supplements for 7 days each, in random order, with a two week washout period between each supplement phase. Subjects will not know which supplement they are receiving throughout the study.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Lisa Wood

Address

The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia

Country

Australia

Phone

+61 2 4042 0147

Fax

+61 2 4042 0046

lisa.wood@newcastle.edu.au

Contact person for public queries

Name

Bronwyn Berthon

Address

The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia

Country

Australia

Phone

+61 2 4042 0116

Fax

+61 2 4042 0046

bronwyn.berthon@newcastle.edu.au

Contact person for scientific queries

Name

Lisa Wood

Address

The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia

Country

Australia

Phone

+61 2 4042 0147

Fax

+61 2 4042 0046

lisa.wood@newcastle.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

There is no IPD sharing plan for this trial

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1511	Study protocol				https://nova.newcastle.edu.au/vital/access/manager... [More Details]

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	Soluble fibre supplementation with and without a probiotic in adults with asthma: A 7-day randomised, double blind, three way cross-over trial.	2019	https://dx.doi.org/10.1016/j.ebiom.2019.07.048

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically