Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics - Trial NCT06381193
Access comprehensive clinical trial information for NCT06381193 through Pure Global AI's free database. This phase not specified trial is sponsored by Centros de Investigación de Nutrición y Salud and is currently Completed. The study focuses on Functional Constipation. Target enrollment is 80 participants.
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Study Focus
Sponsor & Location
Centros de Investigación de Nutrición y Salud
Timeline & Enrollment
N/A
Mar 03, 2023
Jul 10, 2023
Primary Outcome
1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06381193
Non-Device Trial