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Trial registered on ANZCTR


Registration number
ACTRN12614000271606
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
14/03/2014
Date last updated
14/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Abnormal fibre utilisation in ulcerative colitis in remission
Scientific title
Does increased dietary fibre intake improve colonic fermentation in patients with ulcerative colitis in remission compared with healthy subjects?
Secondary ID [1] 284199 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis 291304 0
Condition category
Condition code
Oral and Gastrointestinal 291657 291657 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary fibre was supplemented into the habitual diet for two intervention periods of 17 days each. The supplements were introduced at 25% of full dose and incrementally increased to the total dose over 3 days. This was to reduce the risk of gut symptoms to improve compliance.
Arm 1
Fibre added into provided food, at low doses consisting of
2-5 g resistant starch and 2-5 g of wheat bran fibre
Arm 2
15 g resistant starch and 12 g wheat bran fibre.
There was a wash out period of 14 days between intervention arms.

Compliance was measured and monitored with food intake diaries, check lists and returned food items.

Intervention code [1] 288897 0
Treatment: Other
Comparator / control treatment
There was a control comparator for both patient and healthy subject groups. This consisted of an observation of 7 days on their habitual diet, without the intervention of dietary fibre supplementation.
Control group
Active

Outcomes
Primary outcome [1] 291586 0
Composite primary outcome;
Faecal indices:
Faecal daily output, products of fermentation
Faecal starch and non-starch polysaccharide output
Microbial abundance

Faecal output was weighed, pH probed and SCFAs and Phenolic compounds measured with high performamce gas chromatography. Freeze dried faecal samples were analysed with commercial enzyme kits for residual fibres. Microbial abundances were tested with quantative polymerase chain reaction and denaturing gradient gel electrophoresis.
Timepoint [1] 291586 0
After 7 days of usual diet (baseline), after each dietary intervention (after 17 days of supplementation with low or high amounts of fibre).
Secondary outcome [1] 307128 0
Clinical indices:
Tolerability of dietary supplements with regard to bowel symptoms was recorded on a 4 point Likert scale
Timepoint [1] 307128 0
At the end of each dietary intervention period (day 17 of each arm)
Secondary outcome [2] 307129 0
Whole gut transit time
Measured using radio-opaque markers x-rayed in 3 day faecal collection
Timepoint [2] 307129 0
Measured during the last 3 days of each observed period; baseline control period, and both intervention arms.

Eligibility
Key inclusion criteria
Age over 18 years
Diagnosis of ulcerative colitis, in remission

Healthy control inclusion criteria were age over 18 yrs, absence of bowel disease and absence of medication which affect bowel function and microbiota
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of Crohn's disease, colectomy
Use of any of the following medication within the preceding 4 weeks, due to their effect on bowel and or microbial function:
Sulfasalazine, antibiotics, laxatives, topical rectal therapy, codeine or constipating drugs.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via computerised random sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study was planned to be exploratory only, and therefore, no sample size calculations were utilised.
To examine the differences between controls and subjects with UC, unpaired t tests were utilised and, for non-parametric data, the Kruskal-Wallis test was used.
Paired biochemical data were compared using paired t tests. Bonferroni corrections were made to determine statistical significance.
Microbiological data were analysed using the PRIMER 6+Permanova package. The baseline data were analysed using a Euclidian distance matrix and differences between controls and subjects were calculated a one-way Permanova analysis. Differences between volunteers and diets during diet supplementation were assessed using a Euclidian distance matrix followed by a two-way and pair-wise Permanova analysis. DGGE banding patterns were analysed using a Bray-Curtis similarity matrix on log-transformed data followed by Permanova analysis. The Shannon index values, calculated based on log-transformed DGGE banding patterns, were analysed using a Euclidian distance matrix.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2002
Actual
8/07/2002
Date of last participant enrolment
Anticipated
18/08/2008
Actual
18/08/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2167 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 7847 0
3128 - Box Hill Central
Recruitment postcode(s) [2] 7848 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 288825 0
Charities/Societies/Foundations
Name [1] 288825 0
The main author was in receipt of a scholarship from
Gastroenterological Society of Australia
Country [1] 288825 0
Australia
Primary sponsor type
Individual
Name
Sally James
Address
Department of Gastroenterology
Eastern Health Clinical School, Monash University,
Level 2, 5 Arnold Street
Box Hill,
Victoria 3128
Country
Australia
Secondary sponsor category [1] 287520 0
Commercial sector/Industry
Name [1] 287520 0
Commonwealth Scientific and Industrial Research Organisation
Address [1] 287520 0
CSIRO Animal, Food & Health Sciences,
Food Futures National Research Flagship,
Gate 13 Kintore Ave,
Adelaide,
SA 5000
Country [1] 287520 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290666 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 290666 0
5 Arnold St
Box Hill
VIc 3128
Ethics committee country [1] 290666 0
Australia
Date submitted for ethics approval [1] 290666 0
Approval date [1] 290666 0
06/05/2002
Ethics approval number [1] 290666 0
E17 0203

Summary
Brief summary
Already known about fibre and ulcerative colitis is that
a) Fibre intake goals not achieved by patients with ulcerative colitis
b) Gut microbiota differ in patients with ulcerative colitis from healthy people
c) Dietary management of ulcerative colitis is not well established

New Findings are that
a) Patients with inactive ulcerative colitis often have reduced ability to ferment fibre
b) Supplementation with fibre as a combination of resistant starch and wheat bran-associated non-starch polysaccharide is well tolerated in patients with ulcerative colitis in remission
c) Supplementation with this fibre combination tends to normalise gut transit, but does not increase the proportion of dietary fibre fermented
d) Diminished fermentation is not related to rapid gut transit, but more likely resides in the abnormal microbiota

Impact on future clinical practice
a) The effects of dietary manipulation directed at changing colonic physiology and/or gut microbiota in healthy subjects cannot be extrapolated to patients with ulcerative colitis
b) Supplementation with a combination of resistant starch and wheat bran in patients with ulcerative colitis may have some benefits to colonic physiology and health
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46686 0
Dr Sally L James
Address 46686 0
Department of Gastroenterology
Eastern Health Clinical School
Monash University
5 Arnold St
Box Hill
Vic 3128
Country 46686 0
Australia
Phone 46686 0
61 3 9094 9555
Fax 46686 0
Email 46686 0
[email protected]
Contact person for public queries
Name 46687 0
Dr Sally L James
Address 46687 0
Department of Gastroenterology
Eastern Health Clinical School
Monash University
5 Arnold St
Box Hill
Vic 3128
Country 46687 0
Australia
Phone 46687 0
61 3 9094 9555
Fax 46687 0
Email 46687 0
[email protected]
Contact person for scientific queries
Name 46688 0
Dr Sally L James
Address 46688 0
Department of Gastroenterology
Eastern Health Clinical School
Monash University
5 Arnold St
Box Hill
Vic 3128
Country 46688 0
Australia
Phone 46688 0
61 3 9094 9555
Fax 46688 0
Email 46688 0
[email protected]

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

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