Dietary Supplements for Reduction of Intestinal Permeability Levels
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary supplement Group.
- Who it may be relevant to
- Registry conditions: Intestinal Permeability, Leaky Gut Syndrome, Zonulin. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Dietary supplement Dietary supplement Group
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 outcome measures
- Zonulin levels in feces [Time frame: 60 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Universidad Complutense de Madrid — Madrid
Publications
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06760377 · UComplutenseMadrid Intestinal