How Differences in the Composition of Microorganisms in the Soil Affect the Microorganisms in the… (NCT07742319) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
How Differences in the Composition of Microorganisms in the Soil Affect the Microorganisms in the Human Gut, Through the Vegetables That Grow in it: a Process Pilot Study With Healthy Participants
Netherlands10 participantsStarted 2026-08
Plain-language summary
There are two objectives for this clinical trial. The first is to test whether, with the current logistics and study setup it is possible to perform the study well and see where there might be bottlenecks we couldn't predict. The second objective is to investigate the relation between the composition of the microorganisms in the soil, the crops that grow in that soil, and the human gut. During the study participants will drink three vegetable smoothies a day, for two periods of one week. The only difference between the two periods is whether the vegetables come from a farm with a low diversity of microorganisms in the soil or a high diversity. Participants will be asked to give blood samples and turn in fecal samples before and after each period.
Who can participate
Age range
18 Years – 70 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:
* Aged 18 to 70 years
* Written informed consent
* Inhabitant of Leiden
Exclusion Criteria:
* Any documented causes of chronic disease
* Suspicion of or present excessive alcohol use defined as \>2 units/day (\>14/week)
* Recent use (\<3 months) of antibiotics
* Any known food allergy or restriction, or following a vegan/vegetarian diet
* Use of possible drugs interfering microbiota or recent (\< 3 months) changes in dosages
* A psychiatric, addictive or any other disorder that compromises the participants ability to understand the study content and to give written informed consent for participation in the study
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
Feasibility of logistics of the study protocol: Deliveries
Timeframe: From start enrollment to the end of treatment at 4 weeks
2
Feasibility of logistics of the study protocol: Preparation of the intervention product
Timeframe: From the start of the treatment period until the end at 4 weeks
3
Feasibility of logistics of the study protocol: Recruitment rate
Timeframe: From the start of recruitment until the start of the study
4
Tracing back life microorganisms from the smoothie in stool samples