Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001286235
Ethics application status
Approved
Date submitted
4/07/2018
Date registered
31/07/2018
Date last updated
17/11/2022
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Christchurch IBS cohort to investigate mechanisms for
gut relief and improved transit - Psyllium and Kiwifruit translation study
Scientific title
The feasibility of using the methods and questionnaires developed during an observational study for a psyllium and kiwifruit intervention in participants with or without irritable bowel syndrome and constipation
Secondary ID [1] 295400 0
Nil known
Universal Trial Number (UTN)
U1111-1216-6662
Trial acronym
COMFORT – PSYKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 308629 0
Irritable Bowel Syndrome 308630 0
Condition category
Condition code
Oral and Gastrointestinal 307578 307578 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Oral intake of two SunGold Kiwifruit daily, for a minimum of three weeks and a maximum of four weeks, in a randomised, single blinded, cross-over study.
-If participant is unable to come to the clinic after exactly 4 weeks, an earlier visit (up to 7 days before the end of week 4) is allotted to prevent participants from running out of intervention materials.
- Study duration is 2 weeks baseline, minimum of 3 weeks intervention I, minimum of three weeks washout, minimum of three weeks intervention II, two weeks follow up.
- Kiwifruits will probably have a weight of ~50-70 g (no information from italian growers yet)
- Fruit will be provided by the research team in bulk
- The participants will take the interventions at home
- leftover fruit will be counted to measure adherence
- Biological samples (blood, breath, urine stool) will be collected at baseline, after intervention one, after wash out, after intervention two, and after follow up.
- Samples will be analysed as during the COMFORT study (targeted and untargeted metabolome, transcripome, microbiome, bile acids, inflammation markers, neurotransmitters).
- Questionnaires (as used for the COMFORT cohort) will be filled out by participants throughout the 16 weeks and used to collect data on mental health, socioeconomic status, lifestyle, gastrointestinal and overall health, food and bowel movement diaries.
- The data generated with the questionnaires will be correlated to the data of the biological samples, to the group they are in, as well as to intervention they received at each phase, to see how the interventions affects each group, if the interventions have different effects and outcomes, and if changes occur in any of the domains during non-intervention phases as well.
Intervention code [1] 301710 0
Treatment: Other
Comparator / control treatment
- Oral intake of psyllium powder mixed in liquid daily, for a minimum of three weeks and a maximum of four weeks, in a randomised, single blinded, cross-over study.
- Study duration is 2 weeks baseline, minimum of 3 weeks intervention I, minimum of three weeks washout, minimum of three weeks intervention II, two weeks follow up.
- Psyllium amount will be matched to the fiber content of kiwifruit. We do not have the information of the weight of the fruit from overseas yet. In case the fruit will weigh 80 g, we will need 2.3 g of fiber, which is approximately 1.5 metric teaspoons of BonVit orange psyllium preparation.
- Psyllium will be provided by the research team in bulk, together with medical teaspoons
- The participants will take the interventions at home
- Leftover psyllium will be weighted to measure adherence
Biological samples (blood, breath, urine stool) will be collected at baseline, after intervention one, after wash out, after intervention two, and after follow up.
- Samples will be analysed as during the COMFORT study (targeted and untargeted metabolome, transcripome, microbiome, bile acids, inflammation markers, neurotransmitters).
- Questionnaires (as used for the COMFORT cohort) will be filled out by participants throughout the 16 weeks and used to collect data on mental health, socioeconomic status, lifestyle, gastrointestinal and overall health, food and bowel movement diaries.
- The data generated with the questionnaires will be correlated to the data of the biological samples, to the group they are in, as well as to intervention they received at each phase, to see how the interventions affects each group, if the interventions have different effects and outcomes, and if changes occur in any of the domains during non-intervention phases as well.
Control group
Active

Outcomes
Primary outcome [1] 306554 0
Feasibility of the novel cohort as basis for clinical studies to investigate novel and alternative dietary treatments for digestive function such as high value food and nutraceuticals in regards to recruitment.
The study will be feasible if we are able to enroll 80% of participants before the cut-off point, which is the 14th of December 2018.
Timepoint [1] 306554 0
At the end of the recruitment phase: we will record the number of letters and emails we will send to the participants of the COMFORT cohort (which have consented to future contact during the COMFORT study) and compare this to the numbers of participants who agree to take part in the new study, before we recruit members of the public with advertisements and posters. We also collect the numbers of members of the public we screen and who will decide not to take part despite being eligible.
Primary outcome [2] 306795 0
Feasibility of the novel cohort as basis for clinical studies in regards to completion (how many participants have enrolled vs how many participants finish the study by visiting the clinic for the follow-up visit)
Timepoint [2] 306795 0
At the follow up visit (week 16)
Primary outcome [3] 306796 0
Composite outcome: feasibility of the novel cohort as basis for clinical studies in regards to the burden in answering questionnaires and visiting the clinic .
We will ask the participants how comfortable they were with the large numbers of questionnaires they have to fill out, how hard it was for them to reach the clinic, and what they would like to have changed if they would participate in a similar study.
Timepoint [3] 306796 0
At the follow up visit (week 16)
Secondary outcome [1] 348860 0
A change in GSRS ratings in the FC/IBS group with both interventions
GSRS is a questionnaire, which is filled out by participants weekly.
Timepoint [1] 348860 0
Assessed weekly for the duration of the study (from baseline to 16 weeks)
Secondary outcome [2] 348861 0
A change in complete spontaneous bowel movements in FC/IBS-C group during the interventions in comparison to baseline, wash out, and follow up.
Assessed daily with the daily bowel movement diary.
Timepoint [2] 348861 0
Assessed daily from baseline to 16 weeks.
Secondary outcome [3] 349671 0
Feasibility of the novel cohort as basis for clinical studies in regards to adherence to protocol.
We measure vitamin C to test if they ate the kiwifruit. We check if they have filled out all questionnaires, or if they left some of them blank. We weigh the psyllium they bring back to see if they may have taken it or stopped during the time. We write up if participants stop showing up during the 16 weeks.
This is a composite outcome.
Timepoint [3] 349671 0
Assessed at the end of each phase; week 2, week 6, week 10, week 14, week 16.

Eligibility
Key inclusion criteria
Healthy volunteers without FC/IBS for the control group, and
presence of functional constipation according to ROME IV Diagnostic Criteria or presence of mild IBS-C based on the Rome IV Diagnostic Criteria for the IBS/FC group.

We used participants without IBS/FC for the COMFORT cohort, to be able to compare data (biological and questionnaire) from a "healthy" digestion to "disordered" digestion. These are the two groups.
However, in this feasibility study, both groups will be analysed in regards to baseline , during both interventions, and during wash out and follow up, since we are interested how digestion may change in both groups over time in a future clinical trial.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a BMI under 18 or over 35
uncontrolled diabetes
Inability to give informed consent
Pregnancy, breastfeeding or planning a pregnancy in the three months post selection (study time frame)
Alarm features associated with bowel habit, such as recent changes in bowel habits (onset less than three months), rectal bleeding, sudden weight loss, occult blood in stool, anaemia, anal fissures, bleeding haemorrhoids, and family history of GI cancer at a young age or IBD
Known significant gastrointestinal disorder other than IBS-C, such as IBD, diverticulitis, coeliac disease, or previous bowel resection
Chronic disease such as cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke
Fasting blood glucose of over 6.0 mmol/l
Known kiwifruit or latex allergy
Laxative use and inability or unwillingness to stop laxative use for the seven days before sample collections.
An IBS Severity Index score of over 300.


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)
Randomisation by computer by an unblinded research team member who is not the investigator or involved in analysis. That member is also responsible for handing out the treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Both interventions are considered positive controls, and this study is conducted as a feasibility trial, neither a superiority trial nor a non-inferiority trial. In this case, the Guidelines of the Committee for Proprietary Medicinal Products (CPMP) does not require the use of “intention- to-treat” (ITT) over the “per-protocol” (PP) analysis*, since they are considered to be equal. We intent to use both analyses to gain a robust outcome with a high level of confidence.
Categorical variables will be applied to Chi-squared tests (or Fisher’s exact tests for small samples) while continuous variables will be applied to (parametric) t-tests and (non-parametric) Mann-Whitney/Kruskal –Wallis tests for symmetrically and asymmetrically distributed data, respectively

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/08/2018
Actual
28/09/2018
Date of last participant enrolment
Anticipated
31/08/2019
Actual
30/08/2019
Date of last data collection
Anticipated
21/12/2019
Actual
23/12/2019
Sample size
Target
70
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 10602 0
New Zealand
State/province [1] 10602 0
Canterbury

Funding & Sponsors
Funding source category [1] 299990 0
Other Collaborative groups
Name [1] 299990 0
AgResearch
Country [1] 299990 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
Department of Medicine
PO box 4345
8011 Christchurch
Country
New Zealand
Secondary sponsor category [1] 299371 0
Individual
Name [1] 299371 0
Simone Bayer
Address [1] 299371 0
Co-PI
University of Otago, Christchurch
Department of Medicine
PO box 4345
8011 Christchurch
Country [1] 299371 0
New Zealand
Secondary sponsor category [2] 299373 0
Individual
Name [2] 299373 0
Richard Gearry
Address [2] 299373 0
Principal Investigator
Department of Medicine
PO Box 4345
8011 Christchurch
Country [2] 299373 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300845 0
Southern Health and Disability Ethics Comitee
Ethics committee address [1] 300845 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 300845 0
New Zealand
Date submitted for ethics approval [1] 300845 0
25/07/2018
Approval date [1] 300845 0
18/09/2019
Ethics approval number [1] 300845 0
18/STH/154

Summary
Brief summary
The Christchurch IBS cohort to investigate mechanisms for gut relief and improved transit (COMFORT) was launched in 2016 as a systems approach to gain a wide range of clinical, psychological, biological, and, as a novelty, dietary data.
We believe that the approach used by the COMFORT study is the ideal basis to evaluate food as treatment options in FGIDs.
To test this, we have chosen two SunGold(TM) Kiwifruit a day, and compare this with a fibre matched psyllium preparation in a randomized cross-over study over the course of a maximum of 16 weeks, with each intervention being between 3 and 4 weeks long. We hypothesise that the Interventions will improve gastrointestinal symptoms as assessed by GSRS ratings in the FC/IBS-C group, as well as increase bowel movements. Additionally, we hope to find differences in microbiome and metabolome depending on the participant groups and interventions.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2856 2856 0 0
/AnzctrAttachments/375488-Participant Information Sheet.pdf (Participant information/consent)

Contacts
Principal investigator
Name 85010 0
Prof Richard Gearry
Address 85010 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch
Country 85010 0
New Zealand
Phone 85010 0
+64 3 364 1790
Fax 85010 0
Email 85010 0
[email protected]
Contact person for public queries
Name 85011 0
Prof Richard Gearry
Address 85011 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch
Country 85011 0
New Zealand
Phone 85011 0
+64 3 364 1790
Fax 85011 0
Email 85011 0
[email protected]
Contact person for scientific queries
Name 85012 0
Dr Simone Bayer
Address 85012 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch
Country 85012 0
New Zealand
Phone 85012 0
+64 3 364 1790
Fax 85012 0
Email 85012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data is not available for the public. it would be a breach of data security.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTwo Gold Kiwifruit Daily for Effective Treatment of Constipation in Adults-A Randomized Clinical Trial.2022https://dx.doi.org/10.3390/nu14194146
N.B. These documents automatically identified may not have been verified by the study sponsor.