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Heat-treated Postbiotic Consumption in Healthy People With Mild to Moderate Gastrointestinal Symptoms

NCT05367427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-15

No results posted yet for this study

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, postbiotics 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 a heat treated postbiotic B. longum CECT 7347 on mild-moderate functional digestive disorders in a group of healthy people.

Conditions

  • Healthy
  • Gastrointestinal Dysfunction

Interventions

DIETARY_SUPPLEMENT

Heat treated postbiotic Bifidobacterium Longum consumption

Regular consumption in breakfast of heat treated postbiotic B. longum

DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Sponsors & Collaborators

  • Biopolis S.L.

    collaborator INDUSTRY

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-07-31
Completion
2022-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367427 on ClinicalTrials.gov