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Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients

NCT03103958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-04-07

No results posted yet for this study

Summary

The probiotic for oral use, Probiatop®, consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019. Its activity will be compared with placebo (Maltodextrin). The metagenomics data will be correlated with the Quality of Life Questionnaire answers obtained from participants with intestinal transit problem. The Increase in the number of evacuations, as well as the improvement of complaints related to intestinal transit alteration will be evaluated during the study. The participants will use probiotic or placebo for a period of 28 days and the gastrointestinal function questionnaire and collect stool will be performed before the study and after period of treatment

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic

Probiatop is a live microbial preparation saches containing 1g of the formulation composed by Lactobacillus acidophilus NCFM, 10⁹, Lactobacillus rhamnosus HN001 10⁹, Lactobacillus paracasei LPC-37 10⁹, Bifidobacterium lactis HN019 10⁹ combined with Polydextrose. Subjects will take two sachets per day after diluting them in 100 ml of water

DIETARY_SUPPLEMENT

Placebo

The placebo sachets were prepared by substituting equivalent amounts of Maltodextrin for the probiotic powder. Subjects will take two sachets per day after diluting them in 100 ml of water

Sponsors & Collaborators

  • Farmoquimica S.A.

    lead INDUSTRY

Principal Investigators

  • Ludmila Donato, Monitor · FQM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-28
Primary Completion
2016-08-09
Completion
2016-09-06

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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 NCT03103958 on ClinicalTrials.gov