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NCT Number: NCT06760377

Dietary Supplements for Reduction of Intestinal Permeability Levels

A randomised and controlled trial, in which the effect of a dietary supplement is evaluated for reduction of intestinal permeability levels of subjects with high levels of zonulin in feces

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, Spain

Location contact

Isidro Fernández-López Isidro Fernández-López, PT PhD

CONTACT

[email protected]

34625598970

About this study

Randomized clinical trial, with masking of the statistician and the evaluator, to assess the effect of a food supplement, composed of substances that promote intestinal mucosa repair, on the levels of zonulin in feces and consequently on intestinal permeability. A control group of subjects not receiving any type of supplementation will be used to compare the effectiveness of the treatment.

The main objective of this study is to determine if the use of a dietary supplement composed of glutamine, butyrate and lion's mane, among others, corrects the levels of zonulin in feces.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects between 18 and 65 years of age with elevated levels of zonulin in stool (greater than 80 ng/ml).

Exclusion criteria

  • Taking any type of antibiotic in the last month
  • Taking prebiotics or probiotics products in the last month.
  • Taking laxatives in the last month.
  • Undergoing any medicinal treatment
  • Pregnancy
  • Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.

Treatment and study plan

Dietary supplement Group

Dietary Supplement

Subjects belonging to the experimental group will be provided with the PermeaIntest supplement, which they will take for 60 days, 1 sachet in the morning and 1 sachet in the evening in half a glass of water. Subjects will have a stool sample collected before and after ingestion of the dietary supplement.

Primary outcomes

  1. Zonulin levels in feces

    Time frame: 60 days

    Zonulin levels in feces, assessed in ng/ml

Study contacts

Contact information is provided by the study sponsor or research team.

Isidro Fernández-López Dr. Fernández-López, PT PhD

CONTACT

[email protected]

346255989770

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Acronym: permeability

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 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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