None listed
Conditions
Brief summary
The Body and Brain in IBS Study is a randomised double-blind crossover trial designed to assess the effects of dietary challenge in irritable bowel syndrome. Twenty adults with IBS will undertake five test phases in random order over a 5-week period. During four of the phases, test drinks will be consumed on the first three days of the test phase. Some drinks will contain fructans and some not, During one of the five test phases, no test drinks will be consumed. Each test phase will be separated by a 4-d washout period.
Interventions
Participants will undertake 5 test phases, in random order, of approximately 7 days each in duration. Four of the test phases will begin with 3 consecutive days during which a test drink is consumed each day. These 3 days will be followed by a 4-day washout period during which no test drink is consumed. The same drink will be consumed on days 1, 2 and 3 of each test phase. Some test phases will include test drinks containing fructans, and some will not. The fifth test phase will involve the coll
Participants will undertake 5 test phases, in random order, of approximately 7 days each in duration. Four of the test phases will begin with 3 consecutive days during which a test drink is consumed each day. These 3 days will be followed by a 4-day washout period during which no test drink is consumed. The same drink will be consumed on days 1, 2 and 3 of each test phase. Some test phases will include test drinks containing fructans, and some will not. The fifth test phase will involve the collection of identical outcome measures over 3-days however no test drink will be consumed. Test drinks will be made up by the participants who will add 100 ml of water to opaque bottles. These bottles will contain either 20 g of fructans powder (Orafti® P95 95% oligofructose) or an alternative non-fructan powder. The participant will prepare and consume the study drink within 3 minutes whilst online with a researcher. This study will involve one in-person visit with a researcher at the Alfred Centre, Monash University, Melbourne, where baseline assessments will be completed. Throughout the study, participants will attend a total of 6 brief (approximately 10 minutes each) one-on-one Zoom videoconferencing visits with a blinded researcher. One of these visits will be held on day 1 of each of the five test phases. The sixth online visit (approximately 10 minutes) will be held to debrief participants upon completion of their final washout period. For visits held on day 1 of each test phase, participants will attend fasted from midnight. Fasting will not be required on any other day of each test phase. Participants will collect a hydrogen breath sample, complete a series of questionnaires, and prepare and consume the test drink specified by the researcher whilst being guided and monitored online with the researcher. Participants will then be prompted by scheduled email/text notifications to collect two additional breath samples unsupervised (one each at 3 and 4 hours after consuming the test drink) and complete a brief series of questionnaires. These questionnaires will be completed again at the end of the day (before bed, approximately 15 hours after consuming the test drink). On days 2 and 3 of each test phase, participants will be prompted by scheduled email/text notifications to complete a brief series of questionnaires and prepare and consume a test drink at the same time as on day 1. Participants will also be prompted to complete a brief series of questionnaires at 4 hours and at the end of the day. Adherence to the intervention and completion of daily tasks recorded online will be monitored each test phase through check of completed participant questionnaires on REDCap. Participants will be instructed to keep their background diet unchanged and to maintain current treatment for their IBS during the intervention period.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Australian residents willing to drive to the Alfred Centre in Melbourne, for one study visit • Aged 18-65 years • IBS diagnosed by GP or gastroenterologist and meeting the Rome IV criteria (screened at baseline) • Mild or moderate IBS symptoms (IBS-SSS score 75-300 pts) • Familiar with fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) and fructans • Access to internet on phone, tablet or computer • Able to read and understand materials written in English
Exclusion criteria
• Patient-reported diagnosis of other gastrointestinal diseases (e.g. inflammatory bowel disease, acute diverticulitis coeliac disease) • Patient-reported diagnosis of unstable mental illness (e.g. unstable schizophrenia, other psychotic disorders) • Patient-reported diagnosis of current major medical conditions (e.g., cancer, dementia, type 1 and type 2 diabetes, cardiovascular disease, heart failure, chronic obstructive pulmonary disease). • Patient-reported alcohol/substance abuse • Eating disorder such as anorexia nervosa and bulimia nervosa (i.e. patient-reported or score equal to or greater than 3 on the ‘Sick, Control, One, Fat, Food’ (SCOFF) questionnaire) • Pregnant, planning pregnancy or lactating • Previous extensive GI surgery or stenotic disease e.g., major bowel resection, cholecystectomy (not appendicectomy or haemorrhoidectomy) • Commenced prebiotics, probiotics or antibiotics in the past 4 weeks • Current participation in another clinical trial • Commencement or change in therapy for irritable bowel syndrome in the past month.
Outcome results
None listed