Clinical Trial to Evaluate the Parabiotic Consumption in Healthy People With Mild to Moderate Gastrointestinal Symptoms — BIOPOLIS  

Healthy Clinical Trial

Official title: Clinical Trial to Evaluate the Effect of Regular Consumption of a Microorganism With Probiotic Activity on the Improvement of Symptoms in People With Mild to Moderate Gastrointestinal Disorders Not Associated With Disease

Status Recruiting

Clinical Trial Summary

The use of probiotics is a widespread clinical practice to improve the composition of the microbiota in healthy and pathological patients. However, in recent years, inactivated microorganisms have begun to be used that can exert a certain anti-inflammatory effect at the intestinal level. Among them, Bifidobacterium longum (CECT 7347) has been used in various clinical trials with promising results. It has immunoregulatory properties and an excellent ability to attenuate the activity of epithelial cells at the intestinal level. However, it is necessary to carry out clinical trials to verify its effects, preferably in healthy patients who show certain gastrointestinal discomfort. For this reason, a parallel, randomized, double-blind, controlled pilot clinical trial with 2 study arms has been proposed to assess the effect of habitual consumption of B. longum CECT 7347 on mild-moderate functional digestive disorders in a group of healthy people.

Clinical Trial Description

Recently, there has been a great advance in functional digestive disorders research by new methodological strategies development for their treatment. One of the most interesting line broads the use of probiotics with the aim of reducing the gastrointestinal. The most studied probiotics in this context belong to the genus Bifidobacterium. These microorganisms have shown a remarkable capacity to modulate the inflammatory response, whose efficacy was previously evaluated in celiac patients. Subsequently, different in vitro studies and animal models has been carried out on Bifidobacterium strains, specifically B. longum CECT 7347). Its effect on inflammation caused by gliadins, has reported promising results. This strain is characterized by its anti-inflammatory activity and its ability to recover the intestinal barrier. At the same time, the beneficial effect that probiotics could exert on the maturation of dendritic cells in celiac patients was recently evidenced.

Clinical trials in humans took place once the genome of the B. longum CECT 7347 strain and its safety at the level of oral consumption were studied. Continuing with the work carried out in animal models, the efficacy of oral consumption in celiac patients was evaluated, although studies were also carried out on other individuals with liver or dermatological pathologies. Studies on the use of probiotics led to other areas of research related to spermatogenesis, both in animal models, leaving aside the original study on parameters related to intestinal diseases other than celiac disease.

Gastrointestinal symptoms in adults are usually predominant and have important consequences for health and quality of life. In addition, recent studies suggest that the composition of the intestinal microbiota in those people who have gastrointestinal symptoms may come from intestinal dysbiosis, highlighting the role in the noticeable symptoms. Digestive disorders are characterized by compositional imbalances in the gut microbiota, particularly by a reduced number on both total bifidobacteria and Bifidobacterium longum ES1 (CECT 7347). Recent in vitro studies have shown that the presence of B. longum CECT 7347 reduces the toxic and inflammatory effects on intestinal cells.

The former evidences it has been hypothesised that the administration of B. longum CECT 7347 could modify the composition of the intestinal microbiota due to its immunoregulatory properties and the ability to attenuate the activity of epithelial cells. The proper administrations should attenuate the inflammatory effects, producing a decrease in the prevalence of gastrointestinal symptoms in undiagnosed groups, but which may suffer from a certain intestinal dysbiosis. Based on the above background, a parallel, randomized, double-blind, controlled pilot clinical trial with two study arms has been proposed to assess the effect of habitual consumption of B. longum CECT 7347 on mild to moderate functional digestive disorders in a group of healthy people. ;

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction
• Healthy

• NCT number: NCT05367427
• Study type: Interventional
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Bricia López-Plaza, PhD
• Phone: +34917277000
• Email: bricia.plaza@idipaz.es
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Completion date: October 31, 2022