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OpenTrials
Completed

NCT Number: NCT06626997

Effect of a Symbiotic Drink on the Microbiota

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imdea Food

Madrid, 28049, Spain

About this study

At the beginning of the trial, you will have an interview (screening visit) with a dietician-nutritionist who will explain the entire procedure to you and answer any questions you may have about it. If it is confirmed that you meet the criteria to participate in the study, after your assent and informed consent have been obtained, you will be able to do so. At the first visit, you will be assigned a code by a random method (computerized) and neither you nor the researcher will know whether you are receiving the enriched product or the traditional one that will be used as a control.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kombucha tea

Dietary Supplement

During Visit 1 (week 0), a fasting blood test must be performed at the IMDEA Alimentación facilities to obtain different markers: blood lipids, blood glucose, etc. Approximately 20 mL will be extracted (for comparison, keep in mind that a donation requires 450 mL). The blood sample will be extracted by qualified nursing staff from the UNILABS Laboratory. The blood tests based on the security and privacy requirements for handling samples will be carried out by the same laboratory.

You will also be asked to provide the stool sample that you must have collected at home prior to attending that visit with the material provided at the screening visit (V0) and at the intermediate visit (V2).

Primary outcomes

  1. Relative abundance of the gut microbial species

    Time frame: 6 weeks

    Analyze the variations in the relative abundance of the microbial species present, including taxonomic identification, diversity analysis, and phylogenetic composition.

Sponsors and collaborators

Lead sponsor

IMDEA Food

Other

Registry information

Official study title

Nutritional Intervention Study to Evaluate the Effect of a Symbiotic Drink on the Microbiota and Different Nutritional Markers in Healthy Volunteers

Acronym: KOMFIBRA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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