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Does the use of a wheat dextrin fibre supplement improve bowel performance in patients on dialysis?

Does the use of a wheat dextrin fibre supplement reduce constipation compared to placebo in patients on renal dialysis?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000363583
Enrollment
31
Registered
2015-04-22
Start date
2015-04-23
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to reduce constipation in patients on renal dialysis in the Northland Districy Health Board using a wheat dextrin fibre supplement. The hypothesis is that the use of a wheat dextrin fibre supplement will improve bowel performance, reduce laxative use and improve quality of life in renal dialysis patients in the Northland District Health Board.

Interventions

Patients will be randomly assigned to receive a wheat dextrin fibre supplement or maltodextrin placebo for 4 weeks. After a 2 week washout period followed patients will then receive the opposite treatment to what they did in the first 4 weeks in a randomised crossover study. Patients will increase their supplement use in the first week up to a maximum of 15 grams. This will be done by being instructed to take 6 grams in days 1-3, 12 grams during days 4-6 and 15 grams on day 7. A maximum of 15

Patients will be randomly assigned to receive a wheat dextrin fibre supplement or maltodextrin placebo for 4 weeks. After a 2 week washout period followed patients will then receive the opposite treatment to what they did in the first 4 weeks in a randomised crossover study. Patients will increase their supplement use in the first week up to a maximum of 15 grams. This will be done by being instructed to take 6 grams in days 1-3, 12 grams during days 4-6 and 15 grams on day 7. A maximum of 15 grams will then be taken for the next 3 weeks. The same will occur with the placebo. Both the wheat dextrin fibre supplement and the maltodextrin placebo disolve to be clear and tasteless in drinks and some foods. This is how the supplement will be instructed for patients to consume. All doses in the first week and following three weeks will be instructed to be taken as split doses over the day. For example, 15 grams is instructed to be taken as 9 grams in the morning and 6 grams in the evening. Supplement will be supplied to patients in blank 1L screw top containers with a scoop inside. One flat scoop will measure exactly 3 grams of fibre supplement. For example, when taking 15 grams per day patients are instructed to take 3 scoops in the morning and 2 scoops in the evening. Patients will be instructed to keep a record of how much supplement or placebo they take each day. They will also record their bowel habits and laxative use during the intervention period. Laxative use will be recorded to see if the dose taken can be reduced as the amount of supplement is increased. Phone calls will be made to monitor adherence. These will be scheduled weekly for each patient during each period - Observation, treatment and placebo.

Sponsors

Massey University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Patient must be on peritoneal or haemodialysis - Patients must be taking laxatives

Exclusion criteria

- Those that do not take laxatives and that do not have constipation - Those with dementia - Those who have surgery scheduled in the next few months - Those using opioids - Those with coeliac disease - Those already using wheat dextrin fibre supplement

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026