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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
oral, daily
oral, daily
oral, daily
oral, daily
Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA)
Madrid, Spain
1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation.
Time frame: 8 weeks
To evaluate the stool consistency (Bristol scale).
Type 1-7 (types 3 and 4 indicate a regular transit)
Time frame: 8 weeks
To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20)
Time frame: 8 weeks
To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale).
Time frame: 8 weeks
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