Dietary Supplements for Reduction of Intestinal Permeability Levels

Not Applicable

Not yet recruiting

• Conditions: Intestinal Permeability; Leaky Gut Syndrome; Zonulin

• Registration Number: NCT06760377
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Last Update Submitted: 2024-12-29
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-02-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Zonulin levels in feces	60 days	Zonulin levels in feces, assessed in ng/ml

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain