Clinical trial NCT03103958: Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Bacteria Flora Disturbance
Constipation
Keywords: probiotic
metagenomic
constipation
Lead sponsor: Farmoquimica S.A.
Sponsor class: INDUSTRY
First posted: 2017-04-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Increased number of bowel movements
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of Adverse events
timeFrame: 28 days
measure: Changes of intestinal bacteria flora
timeFrame: 28 days
measure: Improve the quality of life of participants evaluated through quality of life questionnaire
timeFrame: 28 days
measure: Evaluation of symptoms of constipation
timeFrame: 28 days
measure: Improvement of symptoms of constipation
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: FQM
name: Ludmila Donato, Monitor
role: STUDY_CHAIR
References: