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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05980988
Other study ID # WK2023003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2021
Est. completion date April 6, 2023

Study information

Verified date July 2023
Source Wecare Probiotics Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 6, 2023
Est. primary completion date February 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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: 1. Diabetic patients. 2. Pregnant patients. 3. Breastfeeding patients. 4. Patients requiring antibiotic treatment. 5. 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. 6. Patients who change the type of diet during the study. 7. Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study. 8. Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study. 9. Excessive alcohol consumption (>3 glasses of wine or beer/day). 10. Subjects whose condition does not make them eligible for the study, according to the researcher.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic
The experimental phase of this study had last 84 days, and each patient will make 4 visits (d1, d28, d56, d84).
Placebo
Placebo

Locations

Country Name City State
Spain CAP Can Bou Castelldefels and CAP Corbera de Llobregat Barcelona
Spain Family and Community Medicine CAP Roger Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Wecare Probiotics Co., Ltd. Methodex

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in fecal state use Bristol Scale to record the type of fecal state 84 days
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