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NCT Number: NCT07507955

Probiotics for Constipation Relief in Adults

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Improvement of constipation symptoms

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Jin

CONTACT

[email protected]

18336086291

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 2, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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