CompletedNot Applicable

Effect of a Symbiotic Drink on the Microbiota

Spain60 participantsStarted 2024-01-22

Plain-language summary

This study is expected to involve 60 volunteers who will be recruited by IMDEA-Alimentación and randomly assigned between a study group (which will consume the fermented drink) and a control group, which will consume a drink with similar characteristics, but without the presence of bioactive components.

Who can participate

Age range

18 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: * Men and women ≥ 18 years of age. * Caucasian ethnicity * Adequate level of culture and understanding of the clinical study. * Agree to voluntarily participate in the study and give written informed consent. Exclusion Criteria: * Subjects with dementia, mental illness or decreased cognitive function that prevents the study from being carried out. * Subjects with serious diseases (liver, kidney, immunosuppressed, etc.). * BMI ≥ 30 kg/m2, pregnant or breastfeeding women. * Presence of immunological pathologies, gallstones, gastric ulcer or coagulation problems. * Presence of any other specific pathology that contraindicates the intake of dietary supplements, specifically inulin and probiotics (diverticulitis, etc.). * Subjects who are undergoing antibiotic treatment or consuming probiotic supplements. * Subjects who are undergoing pharmacological treatment for weight loss. * Subjects who refuse to follow the guidelines for healthy eating or the consumption of the study drink in the indicated guidelines. * Any other exclusion criteria that the principal investigator of the study considers relevant. * Non-Caucasian ethnicity

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

Relative abundance of the gut microbial species

Timeframe: 6 weeks

Trial details

NCT IDNCT06626997

SponsorIMDEA Food

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-14

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