Dietary Supplements for Reduction of Intestinal Permeability Levels

NCT06760377 | Not Yet Recruiting

• 1 other identifier: UComplutenseMadrid Intestinal
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Intestinal Permeability; Leaky Gut Syndrome; Zonulin

Keywords

intestinal permeability; leaky gut syndrome; zonulin; tight junctions

Outcome Measures

Primary Outcomes (1)

• Zonulin levels in feces

  Zonulin levels in feces, assessed in ng/ml

  60 days

Study Arms (2)

Dietary supplement Group

EXPERIMENTAL

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.

Dietary Supplement: Dietary supplement Group

Control group

NO INTERVENTION

A control group of subjects not receiving any type of supplementation will be used to compare the effectiveness of the treatment. Subjects will have a stool sample collected before and after a period of 60 days

Interventions

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.

Dietary supplement Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Spain

Location

Related Publications (5)

• Fasano A, Shea-Donohue T. Mechanisms of disease: the role of intestinal barrier function in the pathogenesis of gastrointestinal autoimmune diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Sep;2(9):416-22. doi: 10.1038/ncpgasthep0259.

  PMID: 16265432 RESULT

• Fasano A. Regulation of intercellular tight junctions by zonula occludens toxin and its eukaryotic analogue zonulin. Ann N Y Acad Sci. 2000;915:214-22. doi: 10.1111/j.1749-6632.2000.tb05244.x.

  PMID: 11193578 RESULT

• Lerner A, Matthias T. Changes in intestinal tight junction permeability associated with industrial food additives explain the rising incidence of autoimmune disease. Autoimmun Rev. 2015 Jun;14(6):479-89. doi: 10.1016/j.autrev.2015.01.009. Epub 2015 Feb 9.

  PMID: 25676324 RESULT

• Fasano A. Zonulin and its regulation of intestinal barrier function: the biological door to inflammation, autoimmunity, and cancer. Physiol Rev. 2011 Jan;91(1):151-75. doi: 10.1152/physrev.00003.2008.

  PMID: 21248165 RESULT

• Tripathi A, Lammers KM, Goldblum S, Shea-Donohue T, Netzel-Arnett S, Buzza MS, Antalis TM, Vogel SN, Zhao A, Yang S, Arrietta MC, Meddings JB, Fasano A. Identification of human zonulin, a physiological modulator of tight junctions, as prehaptoglobin-2. Proc Natl Acad Sci U S A. 2009 Sep 29;106(39):16799-804. doi: 10.1073/pnas.0906773106. Epub 2009 Sep 15.

  PMID: 19805376 RESULT

Central Study Contacts

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

CONTACT

346255989770; isidrofe@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: It has been estimated to conduct a trial with subjects who are distributed in two groups: an intervention group of patients to whom supplementation is provided, and a control group of subjects who do not receive any type of supplementation.

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: February 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)