Evaluation of the efficacy of oral enzymes for the treatment of carbohydrate intolerance in Irritable Bowel Syndrome.

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12615000489594
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

People with Irritable Bowel Syndrome, as assessed by Rome III criteria, but otherwise well.

Exclusion Criteria

*People with other diagnosed gastrointestinal disorders such as Coeliac Disease and IBD.
*Non-hydrogen producers as shown on Fructan breath hydrogen test.
*Women who are pregnant or breastfeeding.
*Those with known food allergy likely to affect ability to follow study dietary protocol.
*Those who have taken antibiotics, probiotics or prebiotics within the 4 weeks prior to the study.
*Colonoscopy (bowel prep) within the past 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breath hydrogen - this will measure the amount of carbohydrate which is not absorbed in the small intestine. [Day 2 of each study arm]

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms - these will be measured using a 100mm visual analogue scale as well as a 3 point likert scale.<br>Types of symptoms that will be measured include:<br>*Overall Symptoms<br>*Abdominal pain<br>*Abdominal bloating<br>*Wind<br>*Tiredness and lethargy<br>*Nausea<br>*Heartburn[Day 3 of each study arm]