Status:
COMPLETED
Effectiveness and Safety of Probiotic in Regulating Chronic Constipation
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Collaborating Sponsors:
Methodex
Conditions:
Chronic Constipation
Eligibility:
All Genders
18-65 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05980988
Start Date
September 9 2021
End Date
April 6 2023
Last Update
August 8 2023
Active Locations (2)
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1
CAP Can Bou Castelldefels and CAP Corbera de Llobregat
Barcelona, Spain
2
Family and Community Medicine CAP Roger
Barcelona, Spain