None listed
Conditions
Brief summary
The Christchurch IBS cohort to investigate mechanisms for gut relief and improved transit (COMFORT) was launched in 2016 as a systems approach to gain a wide range of clinical, psychological, biological, and, as a novelty, dietary data. We believe that the approach used by the COMFORT study is the ideal basis to evaluate food as treatment options in FGIDs. To test this, we have chosen two SunGold(TM) Kiwifruit a day, and compare this with a fibre matched psyllium preparation in a randomized cross-over study over the course of a maximum of 16 weeks, with each intervention being between 3 and 4 weeks long. We hypothesise that the Interventions will improve gastrointestinal symptoms as assessed by GSRS ratings in the FC/IBS-C group, as well as increase bowel movements. Additionally, we hope to find differences in microbiome and metabolome depending on the participant groups and interventions.
Interventions
- Oral intake of two SunGold Kiwifruit daily, for a minimum of three weeks and a maximum of four weeks, in a randomised, single blinded, cross-over study.
-If participant is unable to come to the clinic after exactly 4 weeks, an earlier visit (up to 7 days before the end of week 4) is allotted to prevent participants from running out of intervention materials.
- Study duration is 2 weeks baseline, minimum of 3 weeks intervention I, minimum of three weeks washout, minimum of three weeks intervent
- Oral intake of two SunGold Kiwifruit daily, for a minimum of three weeks and a maximum of four weeks, in a randomised, single blinded, cross-over study. -If participant is unable to come to the clinic after exactly 4 weeks, an earlier visit (up to 7 days before the end of week 4) is allotted to prevent participants from running out of intervention materials. - Study duration is 2 weeks baseline, minimum of 3 weeks intervention I, minimum of three weeks washout, minimum of three weeks intervention II, two weeks follow up. - Kiwifruits will probably have a weight of ~50-70 g (no information from italian growers yet) - Fruit will be provided by the research team in bulk - The participants will take the interventions at home - leftover fruit will be counted to measure adherence - Biological samples (blood, breath, urine stool) will be collected at baseline, after intervention one, after wash out, after intervention two, and after follow up. - Samples will be analysed as during the COMFORT study (targeted and untargeted metabolome, transcripome, microbiome, bile acids, inflammation markers, neurotransmitters). - Questionnaires (as used for the COMFORT cohort) will be filled out by participants throughout the 16 weeks and used to collect data on mental health, socioeconomic status, lifestyle, gastrointestinal and overall health, food and bowel movement diaries. - The data generated with the questionnaires will be correlated to the data of the biological samples, to the group they are in, as well as to intervention they received at each phase, to see how the interventions affects each group, if the interventions have different effects and outcomes, and if changes occur in any of the domains during non-intervention phases as well.
Sponsors
University of Otago, Christchurch
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers without FC/IBS for the control group, and presence of functional constipation according to ROME IV Diagnostic Criteria or presence of mild IBS-C based on the Rome IV Diagnostic Criteria for the IBS/FC group. We used participants without IBS/FC for the COMFORT cohort, to be able to compare data (biological and questionnaire) from a "healthy" digestion to "disordered" digestion. These are the two groups. However, in this feasibility study, both groups will be analysed in regards to baseline , during both interventions, and during wash out and follow up, since we are interested how digestion may change in both groups over time in a future clinical trial.
Exclusion criteria
a BMI under 18 or over 35 uncontrolled diabetes Inability to give informed consent Pregnancy, breastfeeding or planning a pregnancy in the three months post selection (study time frame) Alarm features associated with bowel habit, such as recent changes in bowel habits (onset less than three months), rectal bleeding, sudden weight loss, occult blood in stool, anaemia, anal fissures, bleeding haemorrhoids, and family history of GI cancer at a young age or IBD Known significant gastrointestinal disorder other than IBS-C, such as IBD, diverticulitis, coeliac disease, or previous bowel resection Chronic disease such as cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke Fasting blood glucose of over 6.0 mmol/l Known kiwifruit or latex allergy Laxative use and inability or unwillingness to stop laxative use for the seven days before sample collections. An IBS Severity Index score of over 300.
Outcome results
None listed