Intestinal PermeabilitypermeabilityNCT06760377
Dietary Supplements for Reduction of Intestinal Permeability Levels
A study testing Dietary supplement Group in people with Intestinal Permeability and Leaky Gut Syndrome, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Permeability, Leaky Gut Syndrome, Zonulin
- What is being tested?
- Dietary supplement Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between 18 and 65 years of age with elevated levels of zonulin in stool (greater than 80 ng/ml).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad Complutense de Madrid
Madrid
Isidro Fernández-López Isidro Fernández-López, PT PhD, 34625598970, isidrofe@ucm.es
About this study
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
Read the 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.
- Conditions
- Intestinal Permeability, Leaky Gut Syndrome, Zonulin
- Being tested
- Dietary supplement Group
- Keywords
- intestinal permeability, leaky gut syndrome, zonulin, tight junctions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement GroupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zonulin levels in feces
Zonulin levels in feces, assessed in ng/ml
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intestinal PermeabilityStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidro Fernández López, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760377
- Sponsor's protocol ID
- UComplutenseMadrid Intestinal
- Acronym
- permeability
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16265432Fasano 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.
PubMed 11193578Lerner 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.
PubMed 25676324Fasano 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.
PubMed 21248165Tripathi 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.
PubMed 19805376
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplements for Reduction of Intestinal Permeability Levels
- ClinicalTrials.gov ID
- NCT06760377
- Acronym / sponsor ID
- permeability / UComplutenseMadrid Intestinal
- Conditions
- Intestinal Permeability, Leaky Gut Syndrome, Zonulin
- Keywords
- intestinal permeability, leaky gut syndrome, zonulin, tight junctions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement Group | Experimental | Dietary Supplement: Dietary supplement GroupSubjects 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. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects between 18 and 65 years of age with elevated levels of zonulin in stool (greater than 80 ng/ml).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement GroupSubjects 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 |
Primary outcome
Zonulin levels in feces
Time frame: 60 days
Zonulin levels in feces, assessed in ng/ml
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Results publication: PubMed 16265432Fasano 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.
- Results publication: PubMed 11193578Fasano 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.
- Results publication: PubMed 25676324Lerner 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.
- Results publication: PubMed 21248165Fasano 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.
- Results publication: PubMed 19805376Tripathi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement Group in people with Intestinal Permeability and Leaky Gut Syndrome, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isidro Fernández-López Dr. Fernández-López, PT PhD (346255989770, isidrofe@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zonulin levels in feces (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06760377, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.