Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

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

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 Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 2B CFU/capsule/day BLa80, before meals； Storage: Store in a cool, dry place without sun exposure.	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 Comparator: placebo; Maltodextrin, one capsule/day, before meals； Storage: Store in a cool, dry place without exposure to the sun.	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in fecal state	use Bristol Scale to record the type of fecal state	84 days

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.
• Collaborators: Methodex
• Investigators: Study Chair: METHODEX SL, Methodex

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics；Chronic constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: WK2023003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No