Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05980988

Enrollment

Registered

2023-08-08

Start date

2021-09-09

Completion date

2023-04-06

Last updated

2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Constipation

Keywords

Probiotics；Chronic constipation

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.

Interventions

DIETARY_SUPPLEMENTProbiotic

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

DIETARY_SUPPLEMENTPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Double（Participant, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026