Pilot StudyHUMANITASNCT07742319
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
A study testing Low diversity vegetable smoothie and High diversity vegetable smoothie in people with Pilot Study, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pilot Study
- What is being tested?
- Low diversity vegetable smoothie and High diversity vegetable smoothie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years
- Written informed consent
- Inhabitant of Leiden
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333ZA
Jeroen Maljaars, MD, PhD, +31 71 526 9111, P.W.J.Maljaars@lumc.nl
Jeroen Maljaars, MD, PhD
About this study
Official title: The Effect of Soil Biodiversity on Human Gut Microbiome: a Process Pilot Study (The HUMANITAS Study)
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.
Read the detailed description
This randomized, double-blind, crossover pilot study will be used to assess the feasibility of logistics including vegetable delivery and preparation of the intervention product by the participants themselves. Besides feasibility, we will aim to identify live bacteria and fungi present in the intervention product (smoothies) and trace these back in stool samples.
The gut microbiome is also called the "second genome" to which many protective and life-supporting functions have been externalized. It orchestrates the crosstalk between our own cells and environmental metagenome. Diet and food choices can modulate gut microbiome species and functional diversity, but the mechanisms by which this occurs are unclear. The nutritional quality of crops, the crop microbiome and the soil microbiome may therefore all be involved.
Ten participants will be randomized in a cross-over design, with each participant drinking three 150 mL vegetable smoothies per day for two separate intervention weeks (HiDi vs LoDi soil origin, randomized 1 : 1). During the first week, smoothies will be prepared with the vegetables derived from microbiome-enriched soil (HiDi) or microbiome-impoverished soil (LoDi). Vegetables, a blender, and detailed instructions to prepare the smoothies on-site will be delivered to the participant. Each participant is asked to keep a diary (in the form of a daily Castor questionnaire), with special attention to dietary habits and intake. Furthermore, before and after this specified diet week, blood and stool samples will be collected. After a washout period of two weeks, participants will be offered identical meals in a crossover design.
- Conditions
- Pilot Study
- Being tested
- Low diversity vegetable smoothie, High diversity vegetable smoothie
- Keywords
- gut microbiome, microbiome, cross-over, dietary intervention, soil-plant-gut axis, metagenomics, pilot, feasibility, healthy, Smoothie intervention, randomized controlled trial, soil microbiome, stool samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low diversity vegetable smoothieOther
Vegetable smoothie prepared with crops grown in low-microbial diversity soil
High diversity vegetable smoothieOther
Vegetable smoothie prepared with crops grown in high-microbial diversity soil
| Study group | Role | What they receive |
|---|---|---|
| Crops derived from Low followed by High diversity soil | Active comparator | Participants will be given vegetables, originating from low- or high-microbial diversity soil, to prepare smoothies with. In this arm participants start with vegetables from a low diversity soil, after a washout period of two weeks they will receive vegetables from a high diversity soil. Receives: Other: Low diversity vegetable smoothie; Other: High diversity vegetable smoothie |
| Crops derived from High followed by Low diversity soil | Active comparator | Participants will be given vegetables, originating from low- or high-microbial diversity soil, to prepare smoothies with. In this arm participants start with vegetables from a high diversity soil, after a washout period of two weeks they will receive vegetables from a low diversity soil. Receives: Other: Low diversity vegetable smoothie; Other: High diversity vegetable smoothie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of logistics of the study protocol: Deliveries
The percentage of successful deliveries to the participants in the pre-agreed time window.
Measured: From start enrollment to the end of treatment at 4 weeks
Feasibility of logistics of the study protocol: Preparation of the intervention product
Using the Daily diary (Castor questionnaire), successful preparation of the intervention product is assessed.
Measured: From the start of the treatment period until the end at 4 weeks
Feasibility of logistics of the study protocol: Recruitment rate
Number of recruited participants per month until the start of the study.
Measured: From the start of recruitment until the start of the study
Tracing back life microorganisms from the smoothie in stool samples
Life bacteria present in the smoothies will be cultured and sequenced to then compare to feces samples of participants
Measured: Day 1, Day 7, Day 22, and Day 28
Secondary outcomes (5)
Participant compliance to the study protocol
Compliance with the protocol will be assessed through the daily lifestyle diary (in the form of a Castor questionnaire). Which will capture the number of consumed smoothies (≥95.2%) and number of consumed smoothies at the correct time window (≥80%). As well whether the duration and time of exercise (≥80%), duration and time of nighttime sleeping period (≥80%), timing and content of main meals (≥80%) between the two periods are comparable. For each of the parameters the compliance threshold is indicated above. Based on these parameters we will get a percentage of participants that were compliant.
Measured: From start enrolment until the end of treatment at the end of 4 weeks
Shifts in gut microbiome composition
Metagenomics will be performed on feces samples from participants to get an compositional view of the gut microbiome. Samples will be taken at baseline, Day 8, Day 21, and Day 29
Measured: Baseline, Day 8, Day 21, and Day 29
Sample completeness
percentage of complete sampling sets
Measured: From start of treatment to the end of treatment at 4 weeks
Asses willingness of participants to create their own intervention product
Using the Daily diary (Castor questionnaire), the participants are required to fill in their opinion on creating their own intervention product on a daily basis. This is measured on a 10 point scale, with 1 being equal to never wanting to do it again and 10 being equal to enjoying it. There is also an optional open question where participants can justify their answer.
Measured: From start treatment to end of treatment at 4 weeks
Differences in phytonutrient levels in serum
After confirmation of significant changes in gut microbiome composition, phytonutrient levels will be measured in serum. Serum will be collected at Baseline, Day 8, Day 21, and Day 29
Measured: Baseline, Day 8, Day 21, and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pilot StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Pieter Maljaars, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742319
- Sponsor's protocol ID
- NL-010026
- Acronym
- HUMANITAS
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metagenomic sequencing data from feces and pythonutrient levels in serum (if available)
Publications
Julious, S.A. (2005), Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist., 4: 287-291. https://doi.org/10.1002/pst.185
Hirt H. Healthy soils for healthy plants for healthy humans: How beneficial microbes in the soil, food and gut are interconnected and how agriculture can contribute to human health. EMBO Rep. 2020 Aug 5;21(8):e51069. doi: 10.15252/embr.202051069. Epub 2020 Jul 31.
PubMed 32734701Blum WEH, Zechmeister-Boltenstern S, Keiblinger KM. Does Soil Contribute to the Human Gut Microbiome? Microorganisms. 2019 Aug 23;7(9):287. doi: 10.3390/microorganisms7090287.
PubMed 31450753Fierer N. Embracing the unknown: disentangling the complexities of the soil microbiome. Nat Rev Microbiol. 2017 Oct;15(10):579-590. doi: 10.1038/nrmicro.2017.87. Epub 2017 Aug 21.
PubMed 28824177David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
PubMed 24336217Leeming ER, Louca P, Gibson R, Menni C, Spector TD, Le Roy CI. The complexities of the diet-microbiome relationship: advances and perspectives. Genome Med. 2021 Jan 20;13(1):10. doi: 10.1186/s13073-020-00813-7.
PubMed 33472701Johnson AJ, Zheng JJ, Kang JW, Saboe A, Knights D, Zivkovic AM. A Guide to Diet-Microbiome Study Design. Front Nutr. 2020 Jun 12;7:79. doi: 10.3389/fnut.2020.00079. eCollection 2020.
PubMed 32596250Sanna S, van Zuydam NR, Mahajan A, Kurilshikov A, Vich Vila A, Vosa U, Mujagic Z, Masclee AAM, Jonkers DMAE, Oosting M, Joosten LAB, Netea MG, Franke L, Zhernakova A, Fu J, Wijmenga C, McCarthy MI. Causal relationships among the gut microbiome, short-chain fatty acids and metabolic diseases. Nat Genet. 2019 Apr;51(4):600-605. doi: 10.1038/s41588-019-0350-x. Epub 2019 Feb 18.
PubMed 30778224Albenberg LG, Wu GD. Diet and the intestinal microbiome: associations, functions, and implications for health and disease. Gastroenterology. 2014 May;146(6):1564-72. doi: 10.1053/j.gastro.2014.01.058. Epub 2014 Feb 4.
PubMed 24503132Henao-Mejia J, Elinav E, Jin C, Hao L, Mehal WZ, Strowig T, Thaiss CA, Kau AL, Eisenbarth SC, Jurczak MJ, Camporez JP, Shulman GI, Gordon JI, Hoffman HM, Flavell RA. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 Feb 1;482(7384):179-85. doi: 10.1038/nature10809.
PubMed 22297845Turnbaugh PJ, Backhed F, Fulton L, Gordon JI. Diet-induced obesity is linked to marked but reversible alterations in the mouse distal gut microbiome. Cell Host Microbe. 2008 Apr 17;3(4):213-23. doi: 10.1016/j.chom.2008.02.015.
PubMed 18407065Clemente JC, Ursell LK, Parfrey LW, Knight R. The impact of the gut microbiota on human health: an integrative view. Cell. 2012 Mar 16;148(6):1258-70. doi: 10.1016/j.cell.2012.01.035.
PubMed 22424233
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soil Biodiversity on Human Gut Microbiome: a Process Pilot Study (The HUMANITAS Study)
- ClinicalTrials.gov ID
- NCT07742319
- Acronym / sponsor ID
- HUMANITAS / NL-010026
- Conditions
- Pilot Study
- Keywords
- gut microbiome, microbiome, cross-over, dietary intervention, soil-plant-gut axis, metagenomics, pilot, feasibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, double-blind, crossover pilot study will be used to assess the feasibility of logistics including vegetable delivery and preparation of the intervention product by the participants themselves. Besides feasibility, we will aim to identify live bacteria and fungi present in the intervention product (smoothies) and trace these back in stool samples.
The gut microbiome is also called the "second genome" to which many protective and life-supporting functions have been externalized. It orchestrates the crosstalk between our own cells and environmental metagenome. Diet and food choices can modulate gut microbiome species and functional diversity, but the mechanisms by which this occurs are unclear. The nutritional quality of crops, the crop microbiome and the soil microbiome may therefore all be involved.
Ten participants will be randomized in a cross-over design, with each participant drinking three 150 mL vegetable smoothies per day for two separate intervention weeks (HiDi vs LoDi soil origin, randomized 1 : 1). During the first week, smoothies will be prepared with the vegetables derived from microbiome-enriched soil (HiDi) or microbiome-impoverished soil (LoDi). Vegetables, a blender, and detailed instructions to prepare the smoothies on-site will be delivered to the participant. Each participant is asked to keep a diary (in the form of a daily Castor questionnaire), with special attention to dietary habits and intake. Furthermore, before and after this specified diet week, blood and stool samples will be collected. After a washout period of two weeks, participants will be offered identical meals in a crossover design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crops derived from Low followed by High diversity soil | Active comparator | Other: Low diversity vegetable smoothie, Other: High diversity vegetable smoothieParticipants will be given vegetables, originating from low- or high-microbial diversity soil, to prepare smoothies with. In this arm participants start with vegetables from a low diversity soil, after a washout period of two weeks they will receive vegetables from a high diversity soil. |
| Crops derived from High followed by Low diversity soil | Active comparator | Other: Low diversity vegetable smoothie, Other: High diversity vegetable smoothieParticipants will be given vegetables, originating from low- or high-microbial diversity soil, to prepare smoothies with. In this arm participants start with vegetables from a high diversity soil, after a washout period of two weeks they will receive vegetables from a low diversity soil. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 70 years
- Written informed consent
- Inhabitant of Leiden
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low diversity vegetable smoothieVegetable smoothie prepared with crops grown in low-microbial diversity soil | Other | Crops derived from High followed by Low diversity soil, Crops derived from Low followed by High diversity soil |
| High diversity vegetable smoothieVegetable smoothie prepared with crops grown in high-microbial diversity soil | Other | Crops derived from High followed by Low diversity soil, Crops derived from Low followed by High diversity soil |
Primary outcome
Feasibility of logistics of the study protocol: Deliveries
Time frame: From start enrollment to the end of treatment at 4 weeks
The percentage of successful deliveries to the participants in the pre-agreed time window.
Feasibility of logistics of the study protocol: Preparation of the intervention product
Time frame: From the start of the treatment period until the end at 4 weeks
Using the Daily diary (Castor questionnaire), successful preparation of the intervention product is assessed.
Feasibility of logistics of the study protocol: Recruitment rate
Time frame: From the start of recruitment until the start of the study
Number of recruited participants per month until the start of the study.
Tracing back life microorganisms from the smoothie in stool samples
Time frame: Day 1, Day 7, Day 22, and Day 28
Life bacteria present in the smoothies will be cultured and sequenced to then compare to feces samples of participants
5 secondary outcomes
Participant compliance to the study protocol
Time frame: From start enrolment until the end of treatment at the end of 4 weeks
Shifts in gut microbiome composition
Time frame: Baseline, Day 8, Day 21, and Day 29
Sample completeness
Time frame: From start of treatment to the end of treatment at 4 weeks
Asses willingness of participants to create their own intervention product
Time frame: From start treatment to end of treatment at 4 weeks
Differences in phytonutrient levels in serum
Time frame: Baseline, Day 8, Day 21, and Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- BackgroundJulious, S.A. (2005), Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist., 4: 287-291. https://doi.org/10.1002/pst.185
- Background: PubMed 32734701Hirt H. Healthy soils for healthy plants for healthy humans: How beneficial microbes in the soil, food and gut are interconnected and how agriculture can contribute to human health. EMBO Rep. 2020 Aug 5;21(8):e51069. doi: 10.15252/embr.202051069. Epub 2020 Jul 31.
- Background: PubMed 31450753Blum WEH, Zechmeister-Boltenstern S, Keiblinger KM. Does Soil Contribute to the Human Gut Microbiome? Microorganisms. 2019 Aug 23;7(9):287. doi: 10.3390/microorganisms7090287.
- Background: PubMed 28824177Fierer N. Embracing the unknown: disentangling the complexities of the soil microbiome. Nat Rev Microbiol. 2017 Oct;15(10):579-590. doi: 10.1038/nrmicro.2017.87. Epub 2017 Aug 21.
- Background: PubMed 24336217David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
- Background: PubMed 33472701Leeming ER, Louca P, Gibson R, Menni C, Spector TD, Le Roy CI. The complexities of the diet-microbiome relationship: advances and perspectives. Genome Med. 2021 Jan 20;13(1):10. doi: 10.1186/s13073-020-00813-7.
- Background: PubMed 32596250Johnson AJ, Zheng JJ, Kang JW, Saboe A, Knights D, Zivkovic AM. A Guide to Diet-Microbiome Study Design. Front Nutr. 2020 Jun 12;7:79. doi: 10.3389/fnut.2020.00079. eCollection 2020.
- Background: PubMed 30778224Sanna S, van Zuydam NR, Mahajan A, Kurilshikov A, Vich Vila A, Vosa U, Mujagic Z, Masclee AAM, Jonkers DMAE, Oosting M, Joosten LAB, Netea MG, Franke L, Zhernakova A, Fu J, Wijmenga C, McCarthy MI. Causal relationships among the gut microbiome, short-chain fatty acids and metabolic diseases. Nat Genet. 2019 Apr;51(4):600-605. doi: 10.1038/s41588-019-0350-x. Epub 2019 Feb 18.
- Background: PubMed 24503132Albenberg LG, Wu GD. Diet and the intestinal microbiome: associations, functions, and implications for health and disease. Gastroenterology. 2014 May;146(6):1564-72. doi: 10.1053/j.gastro.2014.01.058. Epub 2014 Feb 4.
- Background: PubMed 22297845Henao-Mejia J, Elinav E, Jin C, Hao L, Mehal WZ, Strowig T, Thaiss CA, Kau AL, Eisenbarth SC, Jurczak MJ, Camporez JP, Shulman GI, Gordon JI, Hoffman HM, Flavell RA. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 Feb 1;482(7384):179-85. doi: 10.1038/nature10809.
- Background: PubMed 18407065Turnbaugh PJ, Backhed F, Fulton L, Gordon JI. Diet-induced obesity is linked to marked but reversible alterations in the mouse distal gut microbiome. Cell Host Microbe. 2008 Apr 17;3(4):213-23. doi: 10.1016/j.chom.2008.02.015.
- Background: PubMed 22424233Clemente JC, Ursell LK, Parfrey LW, Knight R. The impact of the gut microbiota on human health: an integrative view. Cell. 2012 Mar 16;148(6):1258-70. doi: 10.1016/j.cell.2012.01.035.
- Individual participant dataSharing planned: Yes. Metagenomic sequencing data from feces and pythonutrient levels in serum (if available)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low diversity vegetable smoothie and High diversity vegetable smoothie in people with Pilot Study, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Maljaars, MD, PhD (+31 71 526 3575, P.W.J.Maljaars@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of logistics of the study protocol: Deliveries (time frame: From start enrollment to the end of treatment at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07742319, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.