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

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

Study Overview

• Status: Completed
• Conditions: Constipation; Intestinal Bacteria Flora Disturbance
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Agree to adhere to the procedures and requirements of the study and attend the institute on the day (s) and time (s) determined for the evaluations;
• Being able to consent study participation

• Have one or more complaints of change in bowel habits in the last 3 months with onset of symptoms at least 6 months before diagnosis, as described below:

  • Evacuation effort for at least 25% of defecations
  • Lumpy stools, on sausage-shaped or hardened in at least 25% of stools, according to the Bristol scale. number 1, 2 or 3;
  • Incomplete evacuation count in at least 25% of defecations;
  • Feeling of anorectal obstruction / blockage of feces in at least 25% of defecations;
  • Manufactured manuals to facilitate at least 25% of stools (for example, evacuation with digital help, pelvic floor support)

Exclusion Criteria:

• Pregnancy or breast-feeding;
• Known intolerance or allergy to any of the study products;
• Previous history of gastrointestinal surgery;
• Patients with celiac disease or inflammatory bowel disease;
• Patients with psychiatric, cardiologic, respiratory, renal and hepatic disease;
• No acceptance of study admission by the participant; Diagnosis of Clostridium difficile diarrhea in the last 3 months;
• Patients with known immunosuppressive disease;
• Any other gastrointestinal pathology;
• Prior use of antibiotics in less than 30 days;
• Frequent use of laxatives or other medication that alters bowel motility (one week without Use before inclusion)
• Regular treatment with probiotics / symbiotic, including regular use of yogurt with probiotics (One week before use before inclusion)
• Regular use of antidepressant, opioid analgesic, antispasmodic or anticholinergic agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: probiotic; Probiotic consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019 (Probiatop), Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days.	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; Other Names: Probiatop
Placebo Comparator: Placebo; Placebo consists of maltodextrin. Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased number of bowel movements	Participants will record the number of defecations per day in a daily diary during the study	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse events	Participants will record the adverse events in a daily diary during study	28 days
Changes of intestinal bacteria flora	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.	28 days
Improve the quality of life of participants evaluated through quality of life questionnaire	The evaluation was performed through quality of life questionnaire.	28 days
Evaluation of symptoms of constipation	Improvement of symptoms of constipation by criteria and Bristol scale	28 days
Improvement of symptoms of constipation	Improvement of symptoms of constipation by ROME III	28 days

Collaborators and Investigators

• Sponsor: Farmoquimica S.A.
• Investigators: Study Chair: Ludmila Donato, Monitor, FQM

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2016
• Primary Completion (Actual): August 9, 2016
• Study Completion (Actual): September 6, 2016

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: probiotic; constipation; metagenomic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: FE4-PROBIATOP-PA-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No