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Trial record 52 of 226 for:    Intestinal | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103958
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Farmoquimica S.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

Condition or disease Intervention/treatment Phase
Intestinal Bacteria Flora Disturbance Constipation Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2016
Actual Primary Completion Date : August 9, 2016
Actual Study Completion Date : September 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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 Name: 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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of Adverse events [ Time Frame: 28 days ]
    Participants will record the adverse events in a daily diary during study

  2. 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.

  3. 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.

  4. Evaluation of symptoms of constipation [ Time Frame: 28 days ]
    Improvement of symptoms of constipation by criteria and Bristol scale

  5. Improvement of symptoms of constipation [ Time Frame: 28 days ]
    Improvement of symptoms of constipation by ROME III



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103958


Sponsors and Collaborators
Farmoquimica S.A.
Investigators
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Study Chair: Ludmila Donato, Monitor FQM

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Responsible Party: Farmoquimica S.A.
ClinicalTrials.gov Identifier: NCT03103958     History of Changes
Other Study ID Numbers: FE4-PROBIATOP-PA-14
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farmoquimica S.A.:
probiotic
metagenomic
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms