Probiotics for Constipation Relief in Adults

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07507955

Enrollment

105

Registered

2026-04-02

Start date

2026-06-10

Completion date

2027-01-20

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Constipation

Brief 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.

Interventions

DIETARY_SUPPLEMENTProbiotic

BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.

DIETARY_SUPPLEMENTMaltodextrin

Maltodextrin will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.

DIETARY_SUPPLEMENTHigh-activity probiotic group

BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

China

Contacts

CONTACTYing Jin

1959643812@qq.com18336086291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026