Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut (NCT04804319) | Clinical Trial Compass
CompletedNot Applicable
Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut
Denmark63 participantsStarted 2021-04-13
Plain-language summary
The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18.5-30.0 kg/m2 BMI
* Willing to daily collect a urine and stool sample at home and able to store them in their own freezer in a provided containers throughout the 9-days trial
* Willing to eat sweet corn and report corn-intestinal transit time questionnaire
* Willing to record 9 days dietary intake and defecation pattern
* Willing to have blood samples drawn two times
* Owns a device with access to the internet and is willing to use myfood24 platform
* Known ability to tolerate paracetamol and willing to consume ½ paracetamol tablet dissolved in water (250mg)
* Willing to eat rye bread, butter, jam, egg, yoghurt, berries and nuts
Exclusion Criteria:
* Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer´s participation
* Pregnant or lactating women
* Suffering from inflammatory bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO) or inflammatory bowel diseases (IBD)
* Intake of antibiotics, diarrhea inhibitors and laxatives ˂ 1month
* Current chronic or infectious diseases
* Diagnosis of diabetes
* History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
* Frequent intake of painkillers or other medication (mild antidepressants and contraceptive pills are allowed)
* Concurrent participation in another trial
Additional exclusion criteria for the SmartPill sub-study:
* Intake of medications potentially alteri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Faecal pH vs gut microbial saccharolytic/proteolytic metabolism