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Recruiting NCT06944002

NCT06944002 Milk Consumption and Blood Microbiome in Healthy Volunteers

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Clinical Trial Summary
NCT ID NCT06944002
Status Recruiting
Phase
Sponsor Erasmus Medical Center
Condition Healthy
Study Type INTERVENTIONAL
Enrollment 10 participants
Start Date 2025-07-10
Primary Completion 2025-09-15

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Milk product

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 10 participants in total. It began in 2025-07-10 with a primary completion date of 2025-09-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this study is to learn if cfDNA of milk-associated intestinal bacteria (MAIB) is detectable in the bloodstream. The primary question it aims to answer is: \- Does milk consumption simultaneously increase the number of MAIB cfDNA counts in blood samples, as it does in fecal samples? Researchers will compare cfDNA counts of MAIB to those of fecal samples to assess whether the blood microbiome is a valid measure of the gut microbiome, utilizing a self-developed bioinformatics pipeline. Participants will: * Abstain from consuming any dairy products for ten days, followed by drinking milk for 7 consecutive days. * Provide blood and fecal samples before dairy abstinence, as well as at 0, 24, and 48 hours, and one week after the reintroduction of milk.

Eligibility Criteria

Inclusion Criteria: * Age 18-65 years * 18.5 =\< BMI \< 25 kg/m2 * All genders included * Not be lactose intolerant * Willing to consume milk Exclusion Criteria: * Regularly used medications such as antibiotics, steroids, beta blockers, and adrenergic- stimulating agents (self-report) * Regular use of prebiotic and/or probiotics apart from yogurt and young soft cheese (self-report) * Antibiotic intake in the previous months (self-report) * Daily consumption of more than 10 cigarettes (self-report) * Chronic diseases including type 2 diabetes, hypertension, fatty liver disease, cancer, or autoimmune disease (self-report) * Internal diseases, including those of the gastrointestinal tract, lung, heart, vasculature, liver, and kidney (self-report) * Eating disorder or unconventional eating habits (self-report) * Participation in another study (self-report) * Women: pregnancy and breastfeeding (self-report)

Contact & Investigator

Central Contact

Prof. Dr. Maikel P. Peppelenbosch, MD, PhD

✉ m.peppelenbosch@erasmusmc.nl

📞 +31 07032792

Principal Investigator

Prof. Dr. Maikel P Peppelenbosch, MD, PhD

STUDY CHAIR

Erasmus Medical Center

Frequently Asked Questions

Who can join the NCT06944002 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06944002 currently recruiting?

Yes, NCT06944002 is actively recruiting participants. Contact the research team at m.peppelenbosch@erasmusmc.nl for enrollment information.

Where is the NCT06944002 trial being conducted?

This trial is being conducted at Rotterdam, Netherlands.

Who is sponsoring the NCT06944002 clinical trial?

NCT06944002 is sponsored by Erasmus Medical Center. The principal investigator is Prof. Dr. Maikel P Peppelenbosch, MD, PhD at Erasmus Medical Center. The trial plans to enroll 10 participants.

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