Dietary Supplements for Reduction of Intestinal Permeability Levels (permeability)

Universidad Complutense de Madrid

Status: Not yet enrolling

Conditions: Intestinal Permeability; Leaky Gut Syndrome; Zonulin

Treatments: Dietary Supplement: Dietary supplement Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06760377

UComplutenseMadrid Intestinal

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 2 patient groups

Dietary supplement Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary supplement Group

Control group

No Intervention group

Description:

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