Probiotics for Constipation Relief in Adults
ConditionFunctional Constipation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWecare Probiotics Co., Ltd.
About this trial
This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 8 weeks. Clinical outcomes will be assessed using validated gastrointestinal symptom scales, stool characteristics, and quality-of-life measures. In addition, changes in inflammatory and immune markers, gut microbiota composition, metabolic indicators, and gut-brain axis-related parameters will be evaluated to comprehensively determine the effects of BLa36 on intestinal function and overall health.
Eligibility criteria
Qualifiers
Adults aged 18-65 years;
Individuals diagnosed with constipation, defined as fewer than 3 bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2;
Able and willing to comply with all study procedures and complete the study;
Provided written informed consent prior to participation;
Disqualifiers
Recent use of products with similar effects that may interfere with study outcomes; Significant dietary changes during the study period;
History of severe allergy or immunodeficiency;
Pregnant or breastfeeding women, or those planning pregnancy;
Presence of serious systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, endocrine, or malignant conditions);
Trial design
Treatments tested in this trial
- Probiotic
- Maltodextrin
- High-activity probiotic group
Treatment groups
105 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov