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

NCT03103958 | Completed DMC

• 1 other identifier: FE4-PROBIATOP-PA-14
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Intestinal Bacteria Flora Disturbance; Constipation

Keywords

probiotic; metagenomic; constipation

Outcome Measures

Primary Outcomes (1)

• Increased number of bowel movements

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

  28 days

Secondary Outcomes (5)

• Incidence of Adverse events

  28 days

• Changes of intestinal bacteria flora

  28 days

• Improve the quality of life of participants evaluated through quality of life questionnaire

  28 days

• Evaluation of symptoms of constipation

  28 days

• Improvement of symptoms of constipation

  28 days

Study Arms (2)

probiotic

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Probiotic 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

Also known as: Probiatop

probiotic

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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;
• Regular use of antidepressant, opioid analgesic, antispasmodic or anticholinergic agents

Sponsors & Collaborators

• Farmoquimica S.A.: lead

MeSH Terms

Conditions

Constipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ludmila Donato, Monitor

  FQM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 7, 2017
• Study Start: June 28, 2016
• Primary Completion: August 9, 2016
• Study Completion: September 6, 2016
• Last Updated: April 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share