Evaluation of FODMAP enzymes to treat symptoms in patients with irritable bowel syndrome

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000711415

Enrollment

Registered

2025-07-04

Start date

2025-11-12

Completion date

2026-06-30

Last updated

2026-01-05

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

Conditions

None listed

Brief summary

Irritable bowel syndrome (IBS) affects at least 10% of the world's population. Our current go-to symptom management strategy, the low FODMAP diet, is an extremely restrictive diet. 1/4 of people with IBS having disordered eating behaviours making them inappropriate for dietary restriction. Therefore the aim of this study is to evaluate the efficacy of a FODMAP enzyme in a pill form to help break down these foods that contribute to IBS symptoms without the need for a restrictive diet. This study will be a randomised cross-over controlled feeding trial which will require 34 participants to eat provided study meals for a week while taking either the FODMAP enzyme or a placebo. They will then have a minimum 3 week washout before another week of study meals on the pill they did not have the first time allowing each participant to be their own control. Across the study duration will will assess IBS symptoms, breath hydrogen, fatigue, quality of life and psychological indices. We will also be take blood and urine samples to assess intestinal barrier function ('leaky gut'). The primary endpoint will be IBS symptoms as measured by IBS-SSS at completion. We hypothesis that IBS symptoms will be significantly less in the FODMAP enzyme group.

Interventions

This study is a 1 week cross-over feeding trial using a FODMAP enzyme. This will involve consumption of 3 Intoleran Quatrase enzymes in oral capsule form with each provided meal and snack for 1 week. Participants will be expected to consume the capsules with their meals. Food and enzyme diaries will be kept during the week. The wash out period between the two interventions will be a minimum of 3 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Meet the ROME IV criteria for IBS and reported good symptoms control on a low FODMAP diet

Exclusion criteria

any organic gastrointestinal condition, patients on restrictive diets (excluding FODMAP) who are unable to consume the provided diet, supplementary prebiotics or probiotics, pregnant or breastfeeding, inability to speak or read English

Outcome results