Does the consumption of marshmallows reduce the stoma output for patients with ileostomies?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000633785

Acronym

Nil

Enrollment

Registered

2013-06-05

Start date

2013-06-20

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 aim of the trial is to find out whether eating marshmallows helps to reduce the stoma output in people with an ileostomy. Eating marshmallows to reduce stoma output is widely documented on online websites and blogs as well as in the recommendations given by stoma-care therapists. However, there is no evidence to support these recommendations. We will invite people that have had an ileostomy for at least 3 months, are medically stable, with no relevant dietary restrictions and over 18 years of age to take part in the trial. We will use a repeated measures design with random crossover between a 5 day study period and 5 day control period with a 2 day ‘wash out’ in between. Primary outcome: to determine the efficacy of marshmallow intake in reducing stoma output in patients with ileostomies. Hypotheses: a) Marshmallow in take will reduce daily stoma output volumes b) Marshmallow intake will reduce the frequency of daily stoma bag empties and changes

Interventions

This is a crossover trial. Participants will consume 3 marshmallows, 3 times per day (9 marshmallows in total) for 5 days and complete another 5 days with a marshmallow free diet. There will be a 2 day washout period.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Received permanent or temporary ileostomy at least 3 months ago 2. Age over 18 years 3. Consent received by principle investigator

Exclusion criteria

1. A planned or actual change in medications (including motility agents or steroids) over the study period as reported by patient or new medication started less than 2 weeks before trial commencement 2. Illness requiring hospitalization or change in underlying disease that would effect stoma output and necessitate change in medications during trial period (eg. flare of underlying Crohn’s disease) 3. A medical condition (including diabetes) that precludes the intake of marshmallows 4. Dietary restriction of gelatine

Outcome results