Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000384651
Ethics application status
Approved
Date submitted
21/03/2014
Date registered
9/04/2014
Date last updated
9/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of a novel starch in participants suffering a functional bowel disorder
Scientific title
A placebo controlled double-blind cross over study in participants suffering a functional bowel disorder comparing the effects of supplementation with butyrylated high amylose starch (HAMSB) with placebo starch (low amylose maize starch, LAMS) on overall gastrointestinal symptoms.
Secondary ID [1] 284304 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional bowel disorder 291453 0
Subjects suffering from a functional bowel disorder (Under Rome II criteria) 291569 0
Condition category
Condition code
Oral and Gastrointestinal 291947 291947 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
Treatment interventions were dietary butyrylated high amylose maize starch (HAMSB) or low amylose maize starch (LAMS) which were consumed daily for 14 days, The starch supplement (HAMSB or placebo starch) consisted of two pre-packed 20 g sachets daily, one consumed in the morning and one in the evening. The supplements were consumed by mixing the starches into 250 mL reduced fat flavoured UHT milk, orange juice, water or foods by the participants. The first intervention was followed by a washout period of 4 weeks during which the participants did not consume any intervention and ate their normal diets. The washout was followed by 2 weeks consumption of the alternative intervention. All unused sachets were collected to monitor compliance, and SCFA levels will be measured in the stools of subjects to further verify compliance to the test starches.
Intervention code [1] 289027 0
Treatment: Other
Comparator / control treatment
2 weeks intervention of placebo starch, which is a commercially available low amylose cornstarch, consumed orally as per the HAMSB starch.
Control group
Placebo

Outcomes
Primary outcome [1] 291743 0
The first primary outcome is a measure of gastrointestinal symptoms assessed by the use of a validated tool called the "Functional Gastrointestinal Symptom Questionnaire" (FGI), which is based on the Birmingham IBS Symptom Questionnaire. The questionnaire involves the participants answering 14 questions relating to their symptoms on a 1-6 scale where 1=all of the time, and 6=none of the time. Symptoms include: Abdominal pain, loose stools, hard bowel motions, straining to pass motion, troubled by constipation, sleep disturbed by abdominal pain, soiled/leaked faeces, urgency, feeling of not having passed bowel motion, flatulence, bloating.
Timepoint [1] 291743 0
Measurement of gastrointestinal symptoms were made at:
Measurement of gastrointestinal symptoms were made 4 times during the study:
(1) The end of the baseline observational period
(2) The end of interventional period 1
(3) The end of the washout period
(4) The end of intervention period 2
Primary outcome [2] 305118 0
The second primary outcome is a measure of interventions on quality of life using the Irritable Bowel Symptom Quality of Life (IBSQoL) questionnaire. The IBSQoL questionnaire is a validated, self-administered 34 item symptom questionnaire based on a 1 to 5 scale where 1 = not at all and 5 = extremely.
Timepoint [2] 305118 0
Measurement of gastrointestinal quality of life was made at:
(1) The end of the baseline observational period
(2) The end of interventional period 1
(3) The end of the washout period
(4) The end of intervention period 2
Secondary outcome [1] 307379 0
Because there were no significant benefits identified from the investigational product on primary outcomes the blood inflammatory markers were not measured.
However the effects of faecal supernatants from samples collected at baseline from participants with diarrhoea predominant IBS on epithelial barrier function and pain nerve receptors in laboratory preparations were undertaken instead.
Timepoint [1] 307379 0
The modified secondary outcome measures were only undertaken on faecal supernatants from samples collected at the end of the baseline observational period from participants with diarrhoea predominant irritable bowel syndrome.
Secondary outcome [2] 307537 0
Faecal microbial analyses will be undertaken using paired-read 16S rRNA gene amplicon sequencing rather than qPCR.
Timepoint [2] 307537 0
Measurement of faecal microbiota at:
(1) The end of the baseline observational period
(2) The end of interventional period 1
(3) The end of the washout period
(4) The end of intervention period 2
Secondary outcome [3] 344240 0
Faecal short chain fatty acid concentrations
Timepoint [3] 344240 0
Measurement of faecal short chain fatty acid concentrations were made at:
(1) The end of the baseline observational period
(2) The end of interventional period 1
(3) The end of the washout period
(4) The end of intervention period 2
Secondary outcome [4] 344241 0
Food and nutrient intake (including FODMAPs) as measured by 24 hour food recall interviews with dietitians.
Timepoint [4] 344241 0
Food and nutrient intakes were assessed at:
(1) The end of the baseline observational period
(2) The end of interventional period 1
(3) The end of the washout period
(4) The end of intervention period 2

Eligibility
Key inclusion criteria
Medically diagnosed with a functional bowel disorder
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Constipation is only symptom
2. Intolerant to high fibre products
3. Celiac disease
4. Previous abdominal surgery
5. Diabetes
6. Use of antibiotics for 2 months prior to the commencement of the trial
7. Using anti-diarrhoeal drugs
8. Pregnant or breast feeding, or intending to become pregnant during 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)
At the time of allocation, during the study and analysis of samples and outcomes all participants and study staff were unaware which group the participants were allocated into and which treatment they received at any one time. Allocation (to group A or B) was made by an investigator not involved with the study using online randomisation software. the treatment allocations were maintained at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by an independent researcher not involved in the study using online randomisation software (www.randomizer.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
4 week washout period
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
The trial design is a modification of a study based on Murakami et al. (2012, The effect of Lactobacillus brevis KB290 against irritable bowel syndrome: a placebo-controlled double-blind crossover trial. Biopsychosoc Med 2012;6(1):16.), whereby twenty patients were required for the study to be adequately powered (possess power of 80% to detect a difference between two interventions when alpha = 0.05). The present study will recruit up to 40 participants with a medically diagnosed functional bowel disorder (which allows for dropouts/withdrawals).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
24/11/2015
Date of last participant enrolment
Anticipated
Actual
10/10/2016
Date of last data collection
Anticipated
Actual
13/12/2016
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2213 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7892 0
5000 - Adelaide Bc

Funding & Sponsors
Funding source category [1] 288935 0
Hospital
Name [1] 288935 0
RAH Clinical Project Research grant
Country [1] 288935 0
Australia
Funding source category [2] 298938 0
Hospital
Name [2] 298938 0
Royal Adelaide Hospital
Country [2] 298938 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CSIRO Health and Biosecurity
Address
CSIRO Health and Biosecurity, PO Box 10041 Adelaide BC, South Australia 5000
Country
Australia
Secondary sponsor category [1] 287625 0
Hospital
Name [1] 287625 0
Royal Adelaide Hospital, Department of Gastroenterology and Hepatology
Address [1] 287625 0
Dept of Gastroenterology and Hepatology
Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country [1] 287625 0
Australia
Other collaborator category [1] 280010 0
University
Name [1] 280010 0
Dr Claus Christophersen
Address [1] 280010 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive, Joondalup, Perth WA 6027
Country [1] 280010 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290762 0
Research Ethics Committee, Royal Adelaide Hospital
Ethics committee address [1] 290762 0
ROYAL ADELAIDE
HOSPITAL
North Terrace
Adelaide SA 5000
Ethics committee country [1] 290762 0
Australia
Date submitted for ethics approval [1] 290762 0
14/04/2014
Approval date [1] 290762 0
27/03/2015
Ethics approval number [1] 290762 0
HREC reference number: HREC/15/RAH/76
Ethics committee name [2] 299874 0
Health and Medical Research Human Research Ethics Committee
Ethics committee address [2] 299874 0
CSIRO Health and Biosecurity
PO Box 10041 Adelaide BC 5000
Ethics committee country [2] 299874 0
Australia
Date submitted for ethics approval [2] 299874 0
Approval date [2] 299874 0
19/05/2015
Ethics approval number [2] 299874 0
07/2015

Summary
Brief summary
To assess the effectiveness of butyrylated high amylose maize starch (HAMSB) in reducing gastrointestinal symptoms in volunteers suffering a functional bowel disorder.

Aim 1: The primary aim is to determine if ingestion of HAMSB reduces symptoms in subjects that suffer a functional bowel disorder HAMSB.

Aim 2: The secondary aim is to determine the effect of HAMSB on blood inflammatory markers and faecal microbiota in subjects suffering a functional bowel disorder.
Trial website
Trial related presentations / publications
Wardill H, Bowen J, Dmochowska N, Campaniello M, Mavrangelos C, Holloway R, Clarke J, Andrews J, Hughes P. Faecal supernatants from diarrhoea predominant Irritable Bowel Syndrome (IBS) patients disrupt colonic epithelial barrier function and directly activate colo-rectal afferent nerves. Neurogastroenterology and Motility. 2017 29:12.
Public notes

Contacts
Principal investigator
Name 47118 0
A/Prof Jane Andrews
Address 47118 0
Head IBD Service & Education
Dept of Gastroenterology and Hepatology
Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country 47118 0
Australia
Phone 47118 0
618 8222 5207
Fax 47118 0
Email 47118 0
Jane.Andrews@health.sa.gov.au
Contact person for public queries
Name 47119 0
Dr Julie M. Clarke
Address 47119 0
CSIRO Health and Biosecurity, PO Box 10041 Adelaide BC South Australia, 5000
Country 47119 0
Australia
Phone 47119 0
61 8 83038925
Fax 47119 0
Email 47119 0
julie.clarke@csiro.au
Contact person for scientific queries
Name 47120 0
Dr Julie M Clarke
Address 47120 0
CSIRO Health and Biosecurity, PO Box 10041 Adelaide BC South Australia, 5000
Country 47120 0
Australia
Phone 47120 0
61 8 83038925
Fax 47120 0
Email 47120 0
julie.clarke@csiro.au

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Results publications and other study-related documents

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