NCT03103958

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

Phase IV, Double Blind, Randomized, Study Between Probiatop and Placebo for the Assessment of Improving the Gastrointestinal Function and Intestinal Bacterial Flora in Constipated Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Farmoquimica S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

It is a double-blind, randomized, placebo control study that evaluated the action of a probiotic in relation to a placebo in the human intestinal microbiome by the technique of metagenomics, as well as evaluated the effects of this probiotic on the gastrointestinal transit of constipated participants. One hundred and twenty constipated patients will be randomized into two groups:Probiatop or Placebo. The first 22 patients from each group will also perform a metagenomic evaluation through the stool sample collection before and after of treatment. Besides these procedures, all patients will fill out a symptom assessment questionnaire at baseline of the study, and then after 14 and 28 days after the beginning of the treatment.

Conditions

• Intestinal Bacteria Flora Disturbance
• Constipation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-28
• Primary completion: 2016-08-09
• Completion: 2016-09-06
• First posted: 2017-04-07
• Last updated: 2017-04-07