NCT06381193

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Centros de Investigación de Nutrición y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	oral, daily
DIETARY_SUPPLEMENT	Prebiotic	oral, daily
DIETARY_SUPPLEMENT	Probiotic + Prebiotic	oral, daily
DIETARY_SUPPLEMENT	Placebo	oral, daily

Timeline

• Start date: 2023-03-03
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2024-04-24
• Last updated: 2024-04-24

Locations

1 site across 1 country: Spain