Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05980988
• Other study ID #: WK2023003
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

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