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

NCT06381193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-24

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Probiotic

oral, daily

DIETARY_SUPPLEMENT

Prebiotic

oral, daily

DIETARY_SUPPLEMENT

Probiotic + Prebiotic

oral, daily

DIETARY_SUPPLEMENT

Placebo

oral, daily

Sponsors & Collaborators

  • Nutribiotica

    collaborator UNKNOWN

  • Centros de Investigación de Nutrición y Salud

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2023-07-10
Completion
2023-07-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381193 on ClinicalTrials.gov