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

NCT ID: NCT03103958

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-28
• Study Completion Date: 2016-09-06

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo consists of maltodextrin. Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Probiatop

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Farmoquimica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ludmila Donato, Monitor

Role: STUDY_CHAIR

FQM

Other Identifiers

FE4-PROBIATOP-PA-14

Identifier Type: -

Identifier Source: org_study_id