Effect of Probiotics on Functional Constipation in Adults - Trial NCT04437147
Access comprehensive clinical trial information for NCT04437147 through Pure Global AI's free database. This phase not specified trial is sponsored by Luciane Cruz Lopes and is currently Completed. The study focuses on Functional Constipation. Target enrollment is 150 participants.
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Study Focus
Sponsor & Location
Luciane Cruz Lopes
University of Sorocaba
Timeline & Enrollment
N/A
Mar 11, 2020
Jan 28, 2021
Primary Outcome
Changed in the number of Bowel movements. Changed for more than 3 per week was considered a clinical response.,Change in the Bristol stool form scale at 4 weeks after Probiotics. Recovery to types 3-4 was considered a clinical response.
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04437147
Non-Device Trial