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Clinical Trials/NCT05980988
NCT05980988CompletedNot Applicable

Efficacy and Safety of Probiotic BLa80 in Modulating Bowel Habits in Subjects With Chronic Constipation

Wecare Probiotics Co., Ltd.2 sites in 1 country46 target enrollmentStarted: September 9, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
2
Primary Endpoint
changes in fecal state
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Double（Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

changes in fecal state

Time Frame: 84 days

use Bristol Scale to record the type of fecal state

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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