Probiotics for Constipation Relief in Adults

NCT07507955 | Not Yet Recruiting

• 1 other identifier: WK20260328
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 4 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.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

• 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).

  8 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

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.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Maltodextrin

Interventions

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.

Probiotic group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

Probiotics; maltodextrin

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Ying Jin

CONTACT

18336086291; 1959643812@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)