se of glucose to assist fructose absorption in various forms to eliminate symptoms in Irritable Bowel Syndrome (IBS) fructose malabsorbers

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12614000176662
• Lead Sponsor: Monash Univesity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Malabsorb a 35g dose of fructose with a breath hydrogen rise of above 15ppm from baseline considered a positive result, with results being no more than 3 months old. If results were older than this they were retested.
- Have a functional gastrointestinal disorder OR have no significant gastrointestinal symptoms,

Exclusion Criteria

- Other gastrointestinal disease (e.g., Crohn’s, Ulcerative colitis, Coeliac) or diabetes
- Pregnant or breastfeeding.
- Can not have taken antibiotics, probiotics or had colonoscopy preparation in the past 2 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breath hydrogen production will be measured every 20 minutes for the first 4 hours after drinking the sugar solution. Following this, hourly breath samples will be collected for an additional 8 hours.<br>Breath samples are collected by participants breathing into a special mouthpiece connected to breath collection bags. <br>Prior to testing, participants were instructed how to take breath samples by connecting the mouth piece to the breath sample bag, inhale and exhale normally so that the breath sample bag was inflated fully, then seal the bag immediately so that minimal air escaped. <br>Each sample will be subsequently analysed by researchers to test for hydrogen production. [Breath hydrogen will be measured every 20 minutes for the first 4 hours after drinking the sugar solution, and subsequently hourly for the following 8 hours (total 12 hours). ]

Secondary Outcome Measures

Name	Time	Method
Symptom production will be measured via two symptoms diaries (completed at bed time each day). One diary uses a Likert Scale, whilst the other uses a Visual Analogue Scale (VAS) which asks participants to rate the severity of their symptoms on a 100mm line. The diaries will include questions regarding bowel movements and frequency, abdominal pain and discomfort, wind, nausea, heartburn and tiredness/lethargy.<br>Possible risks, side effects and discomforts include some wind, bloating, abdominal pain and discomfort and a temporary (less than 24 hours) increase in the number of bowel actions. This is not expected to be any more than usual symptoms that IBS patients would experience. [Symptoms will be assessed at bedtime each day.]