Dietary Supplements for Reduction of Intestinal Permeability Levels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-06-01

Brief Summary

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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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Detailed Description

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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

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Intestinal Permeability Leaky Gut Syndrome Zonulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dietary supplement Group

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes