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A pilot study to evaluate how novel fibres affect gut health

Evaluating Novel Uses of fibres on Gut Health in Irritable Bowel Syndrome: A Pilot Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618002042224
Acronym
ENOUGH IBS: A Pilot Study
Enrollment
11
Registered
2018-12-20
Start date
2019-01-03
Completion date
2019-04-10
Last updated
2019-12-10

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

Conditions

None listed

Brief summary

Different types of fibre support gut health in different ways. For example, in the large intestine, certain types of fibre are easily broken down by the gut bacteria (through a process called fermentation). Fermentation offers a number of benefits to gut health, but can lead to symptoms in people living with IBS. We have identified several novel types of dietary fibre possessing fermentation characteristics that may be both favourable for gut health and suitable for people living with IBS. The aims of this study are to evaluate the acceptability and tolerability these fibres, the manner that they affect and gut function and whether they are suitable for people living with IBS. To answer these questions, we are asking for both healthy volunteers and those currently living with IBS to participate in a dietary intervention study. This study will involve consuming these novel fibres as part of a regular diet. We aim to recruit a total of 10 participants (5 healthy volunteers; 5 living with IBS). This study will help us better understand how these novel fibres, paving the way for further, clinical trials involving these novel fibres to better understand their potential role in our diets. This study has been initiated by Associate Professor Jane Muir, Head of Translational Nutrition Sciences at the Department of Gastroenterology and will be conducted by Mr. Daniel So as part of his PhD studies.

Interventions

The intervention will consist of three different dietary intervention periods lasting 9 days each. During these periods, participants will consume, in addition to their habitual diet, supplemental meals (e.g. cereals, granola) containing different types of dietary fibre (sugarcane fibre; resistant starch; and a fibre combination (sugarcane fibre ahd resistant starch) in a dose-escalating manner. Three doses of fibre will be investigated in each intervention period. Each dose will last for 3 day

The intervention will consist of three different dietary intervention periods lasting 9 days each. During these periods, participants will consume, in addition to their habitual diet, supplemental meals (e.g. cereals, granola) containing different types of dietary fibre (sugarcane fibre; resistant starch; and a fibre combination (sugarcane fibre ahd resistant starch) in a dose-escalating manner. Three doses of fibre will be investigated in each intervention period. Each dose will last for 3 days. The daily fibre doses are as follows: * Sugarcane fibre: 5g, 10g, 15g. * Resistant starch: 10g, 15g, 20g. * Fibre combination: 20g, 25g, 30g. Meals will be provided for breakfast and afternoon tea daily in the forms of breakfast cereals and snacks respectively. The habitual diets of participants will be adjusted slightly: dietary advice will be provided so that daily fibre intake will be maintained around 20 to 25 grams per day for the duration of the intervention periods. Participants will be provided with symptom diaries and food records to assess the impact of these meals on gastrointestinal function, as well as compliance. A minimum 3-day washout period will separate each intervention arm.

Sponsors

Monash University
Lead SponsorUniversity

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
Yes

Inclusion criteria

Population A: IBS patients * Inclusion criteria: IBS as defined by ROME IV diagnostic criteria. Population B: Healthy controls. * Inclusion criteria: Healthy adults aged = 18 - 65.

Exclusion criteria

Both populations: * Existing or history of organic gastrointestinal disease (i.e. ulcerative colitis, Coeliac disease). * Significant comorbidities (i.e. diabetes, chronic kidney disease). * Use of antibiotic therapies in the month preceding study enrolment. * Consumption of pre- or probiotics in the month preceding study enrolment. * Use of medication potentially affecting GI transit (i.e. hypomotility agents, laxatives). * Pregnancy or planning pregnancy during study period. * Current smoker. * Those unable to provide informed consent. Population B only: * Existing IBS as defined by ROME IV diagnostic criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026