MedTrace Logo

Effect of Probiotics on Functional Constipation in Adults

NCT04437147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-01-29

No results posted yet for this study

Summary

Introduction:

Functional constipation is a symptom-based gastrointestinal disorder without an organic origin (eg, bowel obstruction). It has a prevalence of 14% in adults.

Objective:

The objective of trial is to evaluate the efficacy and safety of two different probiotic blends in adults subjects with functional constipation.

Methods:

A double-blind, randomized, placebo-controlled study will be conducted for up to two years to evaluate the efficacy of two different probiotic mixtures: (Mixture 1) Lactobacillus acidophilus, Bifidobacterium bifidum and Lactobacillus rhamnosus (3 billion CFU); (Mixture 2) Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis, Bifidobacterium animallis (8 billion CFU).

Conditions

  • Functional Constipation

Interventions

DIETARY_SUPPLEMENT

Placebo

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets

DIETARY_SUPPLEMENT

3 Billion UFC strains of probiotics

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 3 billion CFU strains of probiotics

DIETARY_SUPPLEMENT

8 Billion UFC strains of probiotics

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 8 billion CFU strains of probiotics

Sponsors & Collaborators

  • Luciane Cruz Lopes

    lead OTHER

Principal Investigators

  • Fabiana R MITELMAO, master · UNIVERSIDADE DE SOROCABA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2020-11-30
Completion
2021-01-28

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT04437147 on ClinicalTrials.gov