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Crop Microbiome Transfer (CMT Study)

Research on the direct transfer of crop-related microbes to the human gut microbiome - Transfer of the Crop Microbiome: (CMT Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61356
Enrollment
20
Registered
2026-05-11
Start date
2026-06-25
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut microbiome Gut flora

Interventions

Nerac carrots and Alonix lettuce are the crops provided to participants during the 4 weeks intervention.Participants will be asked to add to their regular diets daily intake of 300–350 g of carrots an
Participants will be randomly assigned to one of two dietary groups Conventional or Organic.&nbsp
The two groups will receive identical amounts of carrots and lettuce to supplement to their own diet, that originate from differential agricultural practices:&nbsp
Conventional Group: 10 Participants will receive vegetables grown using high-input agriculture methods also referred to as conventional.Organic Group: 10 Participants will receive vegetables grown usi

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy Volunteers:European Dutch male/femaleBMI: 18-28 kg/m² Age: 18-50 yearsResident in Amsterdam areaAble to understand information and provide informed consent 

Exclusion criteria

Exclusion criteria: Self-reported:Use of pre-, pro-, or synbiotics, Use of systemic antibiotics within 3 months prior to randomization.Current or recent adherence to restrictive diets (e.g., vegan, vegetarian, strictly organic).Gastrointestinal conditions or symptoms, including severe food allergies/intolerances (case-by-case), diarrhoea, haematochezia, IBS (Rome IV), chronic constipation, or major GI diseases (e.g., celiac disease, Crohn’s disease, ulcerative colitis, short bowel syndrome), or GI cancer risk.Metabolic or chronic diseases, including type 1 or type 2 diabetes, cardiovascular disease, autoimmune disorders with GI involvement, neurological/neurodegenerative disorders, or significant psychiatric/eating disorders.Use of relevant medications (e.g., antidiabetics including GLP-1 agonists, statins, PPIs, H2 blockers, pioglitazone, methotrexate, amiodarone).History of major surgeries (e.g., bariatric surgery, cholecystectomy) or planned surgery during the study period.History of invasive malignancy (unless in full remission or low-risk treated cases).Substance use, including smoking, illicit drugs, or excessive alcohol consumption (>5 units/day).Inability or unwillingness to comply with study procedures (e.g., stool collection), participation in another clinical trial, or any condition compromising safety/compliance.Not residing in the Netherlands for the full study duration.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to demonstrate direct transfer of microbes from metagenomic analyzed crops (carrot and lettuce) to the human gut microbiome. Although crop-associated microbes may already be present at baseline, these will only be similar to the ones on our vegetables at higher taxonomic levels (for example at a family, genus, or species level), our analyses will be performed at the strain level. Because our analysis will be performed at the strain level we will be able to track specific strains associated with the lettuce and carrots provided by us. In addition, baseline measurements serve as a within-participant reference, enabling correction for pre-existing microbes and distinguish newly acquired ones. Specifically, we will assess the acquisition, persistence, or loss of crop-derived strains following consumption of the study vegetables. The primary outcome is a binary high strain-transfer rate endpoint (yes/no) defined as achieving a predefined threshold of newly acquired plant-derived strains relative to baseline. Secondary analyses will quantify the number and relative abundance of engrafted strains and the continuous strain-transfer rate.

Secondary

MeasureTime frame
The secondary objective is to assess the transfer of microbial functional potential using faecal metagenomic data (e.g., taxonomic and functional annotations, bacterial strain tracking, phageome analyses, and phage–bacteria interactions), and to analyze differences between microbes associated with low-input (organic) versus high-input (conventional) crops.Both primary and secondary endpoints will be evaluated using weekly stool samples collected from participants.

Countries

Netherlands

Contacts

Public ContactH.J. Herrema

Amsterdam UMC

h.j.herrema@amsterdamumc.nl+31 681815929

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026