Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

Wecare Probiotics

Status: Completed

Conditions: Chronic Constipation

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05980988

WK2023003

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

2B CFU/capsule/day BLa80, before meals； Storage: Store in a cool, dry place without sun exposure.

Treatment:

Dietary Supplement: Probiotic

placebo

Placebo Comparator group

Description:

Maltodextrin, one capsule/day, before meals； Storage: Store in a cool, dry place without exposure to the sun.

Treatment:

Dietary Supplement: Placebo