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Recruiting Not applicable

Probiotics Improve Constipation

NCT07765004 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-08-07
Last updated
2026-08-17

Condition(s) studied

Constipation

Investigational drug(s) / intervention(s)

ProbiticsPlacebo

Probitics: 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: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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. * Severe psychological or psychiatric disorders. * 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). * 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.

Primary outcome measure(s)

  • Improvement of constipation symptoms — Baseline, Week 1, Week 2, Week 4, Week 8
    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).
  • Change in Spontaneous Bowel Movement (SBM) Frequency — Baseline, Week 1, Week 2, Week 4, Week 8
    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.

Trial sites (1)

FacilityCityRegionStatus
Suzhou Ninth People's Hospital Suzhou Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07765004 on ClinicalTrials.gov ↗ ← All trials in China