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NCT04437147

Effect of Probiotics on Functional Constipation in Adults

The Effect of Probiotics on Functional Constipation in Adults: Double-blind, Randomized, Placebo-controlled Study
Luciane Cruz Lopes·ClinicalTrials.gov·dietary supplementCompleted
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Study focus
Disease/Condition
Functional Constipation
Drug/Device/Intervention
Placebo
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Luciane Cruz Lopes
Funder
University of Sorocaba
Location
Sorocaba, Brazil
Timeline & enrollment
Phase
N/A
Start date
Mar 11, 2020
End date
Jan 28, 2021
Enrollment
150 participants
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
ConstipationOther functional intestinal disordersFunctional intestinal disorder, unspecifiedOther specified functional intestinal disordersOther laxatives
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04437147
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.