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NCT06381193

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

Centros de Investigación de Nutrición y Salud·ClinicalTrials.gov·dietary supplementCompleted
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Study focus
Disease/Condition
Functional Constipation
Drug/Device/Intervention
Probiotic
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Centros de Investigación de Nutrición y Salud
Location
Madrid, Spain
Timeline & enrollment
Phase
N/A
Start date
Mar 03, 2023
End date
Jul 10, 2023
Enrollment
80 participants
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
ConstipationOther functional intestinal disordersFunctional intestinal disorder, unspecifiedOther specified functional intestinal disordersOther laxatives
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06381193
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.