Probiotics for Constipation Relief in Adults (NCT07507955) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Probiotics for Constipation Relief in Adults
China70 participantsStarted 2026-04-15
Plain-language summary
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 4 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Participants (including males) must have no intention of conception from 14 days before screening until 6 months after study completion and agree to use effective contraception.
Exclusion criteria
✕. 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);