Plain English Summary
Background and study aims
Patients with kidney disease need dialysis to replace the work their kidneys are not able to do. One of the types of dialysis available is called Peritoneal Dialysis (PD). It relies on a special fluid being drained in and out of the patients body. If a PD patient becomes constipated, this fluid cannot drain out properly. As a result, the dialysis process stops working. All PD patients are given laxatives to prevent them from becoming constipated. Rather than rely on laxative medicine, this study aimed to improve the intake of dietary fibre as a means of preventing constipation.
Who can participate?
All adult patients on PD were invited to take part if they were using laxatives regularly and wanted to try an alternative.
What does the study involve?
Patients were randomly put into one of three groups. The first group was given dietary fibre in the form of a white powder that dissolved easily in drinks and soft food. The second group was given a white powder that looked the same but had no fibre. This is called a placebo. These two groups did not know which of the powders they had been given. They were told to mix the powder with any drink or food each day for 4 weeks. They had to start gradually in case the powder caused them any discomfort. They were told to continue taking their usual laxatives until they could tell that the powder was having an effect. They were shown how to measure the effect the powder might be having by looking at their stools. If their stools became looser, they were told to reduce their laxatives but keep going with the powder. The third group were given a special diet chart that listed foods containing dietary fibre that were safe for kidney patients to eat. They were told to try and include six to nine items from the list every day to see if they could improve their intake of dietary fibre using normal food.
What are the possible benefits and risks of participating?
The advantage of taking part would be to use a more natural way of controlling bowel function rather than relying on medication. There were no risks involved with this trial. None of the interventions required patients to make changes to their existing therapeutic dietary advice or their medication.
Where is the study run from?
The study was designed by one of the Renal Dietitians and originally tried out in Portsmouth. It was then extended to include other renal units across England. These were Kings College London, York, Royal Berkshire, Sheffield, Exeter, Truro, Plymouth, Kent and Canterbury. In all cases, the work was carried out by one of the Renal Dietitians on each Unit.
When is the study starting and how long is it expected to run for?
The study ran from March 2009 to August 2010.
Who is funding the study?
The study was funded by a grant from the British Renal Society.
Who is the main contact?
Debbie Sutton, Renal Research Dietitian
Debbie.sutton@porthosp.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Debbie Sutton
ORCID ID
Contact details
Portsmouth - Queen Alexandra Hospital
Renal Unit
Portsmouth
PO6 3LY
United Kingdom
+44 23 9228 6000
debbie.sutton@porthosp.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5807
Study information
Scientific title
A multicentre randomised trial to assess whether increased dietary fibre intake (using a fibre supplement or high fibre foods) reduces laxative requirement in free living Peritoneal Dialysis patients
Acronym
Study hypothesis
The main aim of this study is to investigate whether a daily bowel habit of appropriate consistency may be achieved through a higher fibre diet and minimal use of laxatives.
Objectives:
We will conduct the study to:
1. Establish current bowel habits, fibre intake, laxative use and costs, and the prevalence of constipation among all peritoneal dialysis (PD) programme patients
2. Test whether an increase in dietary fibre intake by 6 - 12 g per day (using a fibre supplement or high fibre food) results in improved bowel habits and reduced laxative use
3. Ensure that the treatment has no adverse effects on fluid balance or laboratory parameters (potassium, phosphate)
4. Investigate whether an increased fibre intake improves lipid profile
Ethics approval
Portsmouth IOW and SE Hants REC approved on the 18/12/2008 (ref: 08/H0501/123)
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
Intervention
1. Fibre supplement arm
2. High dietary fibre arm
3. Placebo arm
The length of study period in each arm is 4 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Regular bowel activity, measured once at the end of the 4 week intervention period
Secondary outcome measures
1. Has stopped their laxatives
2. Stools equal to 3, 4 or 5 on the Bristol Stool Form
Measured once at the end of the 4 week intervention period.
Overall trial start date
01/03/2009
Overall trial end date
31/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. PD patient for minimum 3 months
2. Regular user of laxatives
3. Aged greater than 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/03/2009
Recruitment end date
31/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Portsmouth - Queen Alexandra Hospital
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Organisation
Portsmouth Hospitals NHS Trust (UK)
Sponsor details
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
British Renal Society
Alternative name(s)
BRS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary