Probiotics Improve Constipation

NCT07765004 | Recruiting

• 1 other identifier: WK20260801
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled trial in which adult subjects with constipation are randomly assigned to either a probiotic group or a placebo group for an 8-week intervention. Through blood and fecal sample analyses combined with multidimensional questionnaire assessments, the study aims to systematically evaluate the efficacy of probiotics in improving gastrointestinal function, immune status, and mental health in patients with constipation.

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• Improvement of constipation symptoms

  Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).

  Baseline, Week 1, Week 2, Week 4, Week 8

• Change in Spontaneous Bowel Movement (SBM) Frequency

  Change from baseline in number of spontaneous bowel movements. Spontaneous bowel movements are defined as bowel movements occurring without the use of laxatives, enemas, or suppositories within the previous 24 hours.

  Baseline, Week 1, Week 2, Week 4, Week 8

Secondary Outcomes (9)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) Score

  Baseline, Week 1, Week 2, Week 4, Week 8

• Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Score

  Baseline, Week 1, Week 2, Week 4, Week 8

• Change in Patient Assessment of Constipation Quality of Life (PAC-QOL) Score

  Baseline, Week 1, Week 2, Week 4, Week 8

• Change in Depression, Anxiety, and Stress Scale-21 (DASS-21) Score

  Baseline, Week 1, Week 2, Week 4, Week 8

• Change in Serum Inflammatory and Immune Markers

  Baseline, Week 8

Study Arms (2)

Probiotics Group

EXPERIMENTAL

Participants receive one sachet (1g) of probiotic powder containing 2.0 × 10¹⁰ CFU per sachet, taken orally once daily for 8 weeks.

Dietary Supplement: Probitics

Placebo Group

PLACEBO COMPARATOR

Matching placebo powder (maltodextrin), identical in appearance, taste, and weight to the probiotic powder, administered orally once daily for 8 weeks.

Dietary Supplement: Placebo

Interventions

Probitics DIETARY_SUPPLEMENT

The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 1, Week 2, Week 4, and Week 8.

Probiotics Group

Placebo DIETARY_SUPPLEMENT

The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 1, Week 2, 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:

• Aged 18 to 65 years (inclusive).
• Diagnosed with constipation, defined as fewer than 3 spontaneous bowel movements per week and/or Bristol Stool Form Scale types 1 or 2.
• Willing and able to comply with the study protocol and complete all required assessments.
• Provide written informed consent prior to any study-related procedures.
• Male and female participants of childbearing potential must agree to use effective contraception voluntarily from 14 days prior to screening until 6 months after the end of the trial. Female participants of non-childbearing potential (e.g., post-menopausal or surgically sterile) are exempt from this requirement.

You may not qualify if:

• Use of products with functions similar to the investigational product within a short period prior to screening that may interfere with the evaluation of study outcomes.
• Intention to change dietary habits significantly during the study period.
• \. Severe allergies or immunodeficiency. 5. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
• \. Severe diseases of vital organs (including cardiovascular, pulmonary, hepatic, or renal disease), metabolic diseases (e.g., diabetes, thyroid disorders), malignancy, or severe immune system disorders.
• \. Use of antibiotics within the past 30 days. 8. Severe psychological or psychiatric disorders. 9. Poor compliance (e.g., failure to take the test product as instructed or failure to attend scheduled follow-up visits) that would preclude a valid assessment of efficacy.
• \. Organic constipation (e.g., caused by structural or pathological conditions).
• \. Irritable bowel syndrome with constipation (IBS-C). 12. History of surgical procedures within 30 days prior to screening that may have caused or contributed to constipation symptoms.
• \. Intake of probiotic or prebiotic supplements within one month prior to the start of the study.
• \. Any other condition that, in the investigator's opinion, would make the participant unsuitable for participation in the study.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ying Jin, Doctor

CONTACT

+86 18336086291; 1959643812@qq.com

Study Design

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

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-07

Locations

CN (1)