Probiotics for Constipation Relief in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Maltodextrin, High-activity probiotic group.
- Who it may be relevant to
- Registry conditions: Functional Constipation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
Overview
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 supplement Probiotic
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 supplement Maltodextrin
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 supplement High-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.
Primary outcome measures
- Improvement of constipation symptoms [Time frame: 8 weeks]
Eligibility criteria
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);
- Use of antibiotics within the past 2 weeks;
- Individuals with severe psychiatric or neurological disorders;
- Poor compliance, including failure to take the study product or attend scheduled visits;
- Any other condition deemed unsuitable by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Suzhou Ninth People's Hospital — Suzhou
Identifiers
NCT: NCT07507955 · WK20260328