Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation.

NCT06277505 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-01

No results posted yet for this study

Summary

In this study, we will evaluate the efficacy of prebiotics combined with quadruple probiotics in the treatment of functional constipation through an open RCT study. The experimental group received lifestyle guidance and combined intervention of prebiotics and quadruple probiotics at the same time. The patients took the combination of prebiotics and probiotics twice a day during the treatment period. The control group received only lifestyle instruction. At the same time, to evaluate the safety of probiotics combined with quadruple probiotics in the treatment of functional constipation, and provide a new treatment plan for clinical treatment of functional constipation.

Conditions

  • Functional Constipation

Interventions

COMBINATION_PRODUCT

Take prebiotics and probiotics

Take 3.5g prebiotic +2g prebiotic twice a day before meals; At the same time, lifestyle guidance is given, including adjusting dietary structure, increasing the intake of foods high in dietary fiber and moderate exercise

BEHAVIORAL

lifestyle guidance

lifestyle guidance is given, including adjusting dietary structure, increasing the intake of foods high in dietary fiber and moderate exercise

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • China

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 NCT06277505 on ClinicalTrials.gov