Trial Review

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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 information initially 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] 286457 0
Nil
Universal Trial Number (UTN)
U1111-1168-9055
Trial acronym
FAIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 294640 0
Condition category
Condition code
Respiratory 294939 294939 0 0
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] 291539 0
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] 294695 0
Plasma short chain fatty acids (SCFA) will be measured before and after each phase of the study.
Timepoint [1] 294695 0
Change in SCFA after 7 days of each treatment arm compared to placebo.
Secondary outcome [1] 313880 0
Systemic Inflammation (Plasma CRP & TNFa)
Timepoint [1] 313880 0
Change in Plasma CRP & TNFa after 7 days of each treatment arm compared to placebo.
Secondary outcome [2] 313881 0
Airway Inflammation (sputum cell counts, IL-8, FeNO)
Timepoint [2] 313881 0
Change in sputum cell counts, IL-8 and FeNO after 7 days of each treatment arm compared to placebo
Secondary outcome [3] 313882 0
Faecal SCFA
Timepoint [3] 313882 0
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?
No
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
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9479 0
2300 - Newcastle
Recruitment postcode(s) [2] 9478 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 291025 0
Hospital
Name [1] 291025 0
John Hunter Hospital Charitable Trust
Country [1] 291025 0
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] 289705 0
Individual
Name [1] 289705 0
Dr Bronwyn Berthon
Address [1] 289705 0
The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country [1] 289705 0
Australia
Secondary sponsor category [2] 289706 0
University
Name [2] 289706 0
The University of Newcastle
Address [2] 289706 0
University Drive, Callaghan, 2308, NSW
Country [2] 289706 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292608 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292608 0
Research Ethics and Governance Unit
Locked bag 1, New Lambton, NSW, 2305
Ethics committee country [1] 292608 0
Australia
Date submitted for ethics approval [1] 292608 0
26/02/2015
Approval date [1] 292608 0
01/04/2015
Ethics approval number [1] 292608 0
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 56210 0
Prof Lisa Wood
Address 56210 0
The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 56210 0
Australia
Phone 56210 0
+61 2 4042 0147
Fax 56210 0
+61 2 4042 0046
Email 56210 0
lisa.wood@newcastle.edu.au
Contact person for public queries
Name 56211 0
Dr Bronwyn Berthon
Address 56211 0
The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 56211 0
Australia
Phone 56211 0
+61 2 4042 0116
Fax 56211 0
+61 2 4042 0046
Email 56211 0
bronwyn.berthon@newcastle.edu.au
Contact person for scientific queries
Name 56212 0
Prof Lisa Wood
Address 56212 0
The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 56212 0
Australia
Phone 56212 0
+61 2 4042 0147
Fax 56212 0
+61 2 4042 0046
Email 56212 0
lisa.wood@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no IPD sharing plan for this trial


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1511Study protocol    https://nova.newcastle.edu.au/vital/access/manager... [More Details]



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSoluble fibre supplementation with and without a probiotic in adults with asthma: A 7-day randomised, double blind, three way cross-over trial.2019https://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.