Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

Not Applicable

Completed

• Conditions: Chronic Constipation
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT05980988
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-09
• Primary Completion: 2023-02-02
• Study Completion: 2023-04-06
• Status Verified: 2023-07
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
changes in fecal state	84 days	use Bristol Scale to record the type of fecal state

Trial Locations

Locations (2)

Family and Community Medicine CAP Roger; 🇪🇸 Barcelona, Spain

CAP Can Bou Castelldefels and CAP Corbera de Llobregat; 🇪🇸 Barcelona, Spain