Clinical Trial: Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: Farmoquimica S.A.

Current Primary Outcome: Increased number of bowel movements [ Time Frame: 28 days ]

Participants will record the number of defecations per day in a daily diary during the study


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Adverse events [ Time Frame: 28 days ]
    Participants will record the adverse events in a daily diary during study
  • Changes of intestinal bacteria flora [ Time Frame: 28 days ]
    Quantitative analysis of the participants' microbiota bacteria by sequencing the 16S rDNA gene and the readings obtained from each participant werw compared with genomic banks for identification of the microorganism.
  • Improve the quality of life of participants evaluated through quality of life questionnaire [ Time Frame: 28 days ]
    The evaluation was performed through quality of life questionnaire.
  • Evaluation of symptoms of constipation [ Time Frame: 28 days ]
    Improvement of symptoms of constipation by criteria and Bristol scale
  • Improvement of symptoms of constipation [ Time Frame: 28 days ]
    Improvement of symptoms of constipation by ROME III


Original Secondary Outcome: Same as current

Information By: Farmoquimica S.A.

Dates:
Date Received: March 17, 2017
Date Started: June 28, 2016
Date Completion:
Last Updated: March 31, 2017
Last Verified: March 2017