A pilot study to evaluate how novel fibres affect gut health

Not Applicable

Completed

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

• Registration Number: ACTRN12618002042224
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-20
• Study Completion: 2019-05-29
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Population A: IBS patients
* IBS as defined by ROME IV diagnostic criteria.
Population B: Healthy controls.
* 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms.<br>Participants will complete symptom dairies, where the following gastrointestinal symptoms will be assessed via 100mm visual analogue scale (VAS): abdominal pain/discomfort; abdominal bloating; wind; tiredness and lethargy; nausea; and overall symptoms.<br>This is a composite primary outcome.[Symptom diaries will be completed daily throughout the baseline and dietary intervention periods.<br>Symptom scores will be averaged over specific dosage days during each intervention period, as well as the length of the baseline period.]

Secondary Outcome Measures

Name	Time	Method
Stool consistency.<br>Assessed via questionnaires incorporating the Bristol Stool Chart.[Questionnaires will be completed daily throughout the baseline and dietary intervention periods.<br>Scores will be averaged over specific dosage days during each intervention period, as well as the length of the baseline period.];Satiety.<br>Assessed via VAS.[On the third day of the baseline period.<br>Every third day of each dietary intervention period];Palatability of supplemental breakfasts.<br>Assessed via VAS.[On the third day of the baseline period.<br>Every third day of each dietary intervention period];Stool frequency assessed questionnaire incorporating Likert scales.[Questionnaires will be completed daily throughout the baseline and dietary intervention periods.<br>Scores will be averaged over specific dosage days during each intervention period, as well as the length of the baseline period.]