NCT05367427: BIOPOLIS

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

Completed NA Last updated 15 August 2024

What this trial tests

NA trial testing Heat treated postbiotic Bifidobacterium Longum consumption in Healthy in 60 participants. Completed in 31 October 2022.

Timeline

1 February 2022

Primary endpoint
31 July 2022

31 October 2022

Quick facts

Lead sponsor	Instituto de Investigación Hospital Universitario La Paz
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	1 February 2022
Primary completion	31 July 2022
Estimated completion	31 October 2022
Sites	1 location across Spain

Drugs / interventions tested

• Heat treated postbiotic Bifidobacterium Longum consumption
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →
• Gastrointestinal Dysfunction — all drugs for Gastrointestinal Dysfunction →

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Who can join

Adults 18 to 65, any sex, with Healthy or Gastrointestinal Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Postbiotic <i>Bifidobacterium longum</i> CECT 7347 on Gastrointestinal Symptoms, Serum Biochemistry, and Intestinal Microbiota in Healthy Adults: A Randomised, Parallel, Double-Blind, Placebo-Controlled Pilot Study.
   Naghibi M, Pont-Beltran A, Lamelas A, Llobregat L, et al · · 2024 · cited 11× · PMID 39599737 · DOI 10.3390/nu16223952
2. Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.
   Girbal-González M, Pérez-Cano FJ. · · 2025 · cited 2× · PMID 41010485 · DOI 10.3390/nu17182960