Probiotics for Constipation Relief in Adults

NCT07507955 — Not applicable, Not yet recruiting, 105 participants, Wecare Probiotics Co., Ltd.

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To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial

Registry	NCT07507955
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	105 (Estimated)
Sponsor	Wecare Probiotics Co., Ltd. (Industry)
Conditions	Functional Constipation
Interventions	Probiotic, Maltodextrin, High-activity probiotic group (Dietary supplement)
Dates	start 2026-06-10 (estimated), primary completion 2026-11-30 (estimated), completion 2027-01-20 (estimated), first posted 2026-04-02, last updated 2026-06-09
Locations	1 site in China

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Probiotic group	Experimental	Dietary Supplement: Probiotic	Participants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks.
Placebo group	Placebo comparator	Dietary Supplement: Maltodextrin	Participants in this group will receive a placebo containing maltodextrin (3 g per sachet), administered once daily for 8 weeks, matched in appearance and administration to the active product.
High-activity probiotic group	Experimental	Dietary Supplement: High-activity probiotic group	Participants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks.

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.

+Outcome measures

Primary outcomes

Improvement of constipation symptoms [8 weeks]: 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).

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

1. Adults aged 18-65 years;
2. Individuals diagnosed with constipation, defined as fewer than 3 bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2;
3. Able and willing to comply with all study procedures and complete the study;
4. Provided written informed consent prior to participation;
5. 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:

1. Recent use of products with similar effects that may interfere with study outcomes; Significant dietary changes during the study period;
2. History of severe allergy or immunodeficiency;
3. Pregnant or breastfeeding women, or those planning pregnancy;
4. Presence of serious systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, endocrine, or malignant conditions);
5. Use of antibiotics within the past 2 weeks;
6. Individuals with severe psychiatric or neurological disorders;
7. Poor compliance, including failure to take the study product or attend scheduled visits;
8. Any other condition deemed unsuitable by the investigator.

+Locations (1)

Facility	City	Country	Status
Suzhou Ninth People's Hospital	Suzhou, Jiangsu	China