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OpenTrials
Completed

NCT Number: NCT05980988

Effectiveness and Safety of Probiotic in Regulating 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.

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Key information

Conditions

Chronic Constipation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAP Can Bou Castelldefels and CAP Corbera de Llobregat, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Diabetic patients.
  • Pregnant patients.
  • Breastfeeding patients.
  • Patients requiring antibiotic treatment.
  • 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.
  • Patients who change the type of diet during the study.
  • Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study.
  • Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study.
  • Excessive alcohol consumption (>3 glasses of wine or beer/day).
  • Subjects whose condition does not make them eligible for the study, according to the researcher.

Treatment and study plan

Probiotic

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. changes in fecal state

    Time frame: 84 days

    use Bristol Scale to record the type of fecal state

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Collaborators

  • Methodex

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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