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NCT06381193

Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics

Completed NA Last updated 24 April 2024
What this trial tests

NA trial testing Probiotic in Functional Constipation in 80 participants. Completed in 10 July 2023.

Timeline
3 March 2023
Primary endpoint
10 July 2023
10 July 2023

Quick facts

Lead sponsorCentros de Investigación de Nutrición y Salud
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment80
Start date3 March 2023
Primary completion10 July 2023
Estimated completion10 July 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Centros de Investigación de Nutrición y Salud

Who can join

Adults 18 to 65, any sex, with Functional Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are: * To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks. * To evaluate the stool consistency after 8 weeks (Bristol scale). * To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks. Participants are randomized into the following groups: * Group A: 20 assigned to probiotic + placebo * Group B: 20 assigned to prebiotic + placebo * Group C: 20 assigned to probiotic + prebiotic * Group D: 20 assigned to the placebo + placebo Participants took 4 units of product per day (2 of each assigned product) for 2 months.

Publications & conference data

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

  1. Supplementation with probiotics, prebiotics, and synbiotics in patients with chronic functional constipation: a randomized, double-blind, placebo-controlled pilot clinical trial.
    Terrén Lora A, Penadés BF, López Oliva S, Arponen S, et al · · 2024 · cited 4× · PMID 39530075 · DOI 10.1093/gastro/goae101
  2. Microbiota-immune crosstalk in the regulation of intestinal motility in constipation.
    Pan Z, Zhang T, Ren Z, Zhang H, et al · · 2026 · PMID 42094762 · DOI 10.3389/fmicb.2026.1828926

Verify or expand the search:

Other trials of Probiotic

Trials testing the same drug.

Other recruiting trials for Functional Constipation

Currently open trials in the same condition.

Other Centros de Investigación de Nutrición y Salud trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06381193.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing