search
Back to results

Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

Primary Purpose

Chronic Constipation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Wecare Probiotics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Probiotics;Chronic constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with chronic constipation (duration more than 3 months with less than three bowel movements per week and/or Bristol Scale 1 and 2). Exclusion Criteria: Diabetic patients. Pregnant patients. Breastfeeding patients. Patients requiring antibiotic treatment. Patients requiring treatment with tricyclic antidepressants, antiepileptics, antihistamines, antiparkinsonians, antipsychotics, antispasmodics, verapamil, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium), antidiarrheals and nonsteroidal anti-inflammatory drugs. Patients who change the type of diet during the study. Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study. Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study. Excessive alcohol consumption (>3 glasses of wine or beer/day). Subjects whose condition does not make them eligible for the study, according to the researcher.

Sites / Locations

  • CAP Can Bou Castelldefels and CAP Corbera de Llobregat
  • Family and Community Medicine CAP Roger

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

placebo

Arm Description

2B CFU/capsule/day BLa80, before meals; Storage: Store in a cool, dry place without sun exposure.

Maltodextrin, one capsule/day, before meals; Storage: Store in a cool, dry place without exposure to the sun.

Outcomes

Primary Outcome Measures

changes in fecal state
use Bristol Scale to record the type of fecal state

Secondary Outcome Measures

Full Information

First Posted
July 28, 2023
Last Updated
August 7, 2023
Sponsor
Wecare Probiotics Co., Ltd.
Collaborators
Methodex
search

1. Study Identification

Unique Protocol Identification Number
NCT05980988
Brief Title
Effectiveness and Safety of Probiotic in Regulating Chronic Constipation
Official Title
Efficacy and Safety of Probiotic BLa80 in Modulating Bowel Habits in Subjects With Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wecare Probiotics Co., Ltd.
Collaborators
Methodex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the effectiveness and safety of the use of probiotics as food supplements in regulating the intestinal habit of subjects with chronic constipation, in comparison with placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Probiotics;Chronic constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Double(Participant, Investigator)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
2B CFU/capsule/day BLa80, before meals; Storage: Store in a cool, dry place without sun exposure.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin, one capsule/day, before meals; Storage: Store in a cool, dry place without exposure to the sun.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
The experimental phase of this study had last 84 days, and each patient will make 4 visits (d1, d28, d56, d84).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
changes in fecal state
Description
use Bristol Scale to record the type of fecal state
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with chronic constipation (duration more than 3 months with less than three bowel movements per week and/or Bristol Scale 1 and 2). Exclusion Criteria: Diabetic patients. Pregnant patients. Breastfeeding patients. Patients requiring antibiotic treatment. Patients requiring treatment with tricyclic antidepressants, antiepileptics, antihistamines, antiparkinsonians, antipsychotics, antispasmodics, verapamil, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium), antidiarrheals and nonsteroidal anti-inflammatory drugs. Patients who change the type of diet during the study. Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study. Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study. Excessive alcohol consumption (>3 glasses of wine or beer/day). Subjects whose condition does not make them eligible for the study, according to the researcher.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
METHODEX SL
Organizational Affiliation
Methodex
Official's Role
Study Chair
Facility Information:
Facility Name
CAP Can Bou Castelldefels and CAP Corbera de Llobregat
City
Barcelona
Country
Spain
Facility Name
Family and Community Medicine CAP Roger
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

We'll reach out to this number within 24 hrs