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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Probiotic
Dietary supplement
BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
Maltodextrin
Dietary supplement
Maltodextrin will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
High-activity probiotic group
Dietary supplement
BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.

Treatment groups

105 Participants

are divided into 3 treatment groups

Group A: Probiotic groupExperimental treatment 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Group C: High-activity probiotic groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Improvement of constipation symptoms

Improvement in constipation will be evaluated using the Bristol Stool Form Scale (BSFS), with particular focus on changes in stool form from type 1-2 (hard stools/constipation) toward type 3-4 (normal stool consistency).

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wecare Probiotics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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