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NCT Number: NCT07765004

Probiotics Improve Constipation

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Ying Jin, Doctor

CONTACT

[email protected]

+86 18336086291

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Improvement of constipation symptoms

    Time frame: 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).

  2. Change in Spontaneous Bowel Movement (SBM) Frequency

    Time frame: 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.

Secondary outcomes

  1. Change in Gastrointestinal Symptom Rating Scale (GSRS) Score

    Time frame: Baseline, Week 1, Week 2, Week 4, Week 8

    Change from baseline in GSRS total and subscale scores. GSRS is a 15-item questionnaire assessing gastrointestinal symptoms across 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation), each rated on a 7-point Likert scale. Higher scores indicate more severe symptoms.

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

    Time frame: Baseline, Week 1, Week 2, Week 4, Week 8

    Change from baseline in PAC-SYM total score. PAC-SYM is a 12-item questionnaire assessing constipation-related symptoms across 3 subscales (abdominal, rectal, stool), each rated on a 5-point Likert scale. Higher scores indicate more severe symptoms.

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

    Time frame: Baseline, Week 1, Week 2, Week 4, Week 8

    Change from baseline in PAC-QOL total score. PAC-QOL is a 28-item questionnaire assessing quality of life related to constipation across 4 domains (physical discomfort, psychosocial discomfort, worries/concerns, satisfaction), each rated on a 5-point Likert scale. Higher scores indicate poorer quality of life.

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

    Time frame: Baseline, Week 1, Week 2, Week 4, Week 8

    Change from baseline in DASS-21 total and subscale scores. DASS-21 is a 21-item questionnaire assessing depression, anxiety, and stress across 3 domains, each rated on a 4-point Likert scale. Higher scores indicate more severe psychological distress.

  5. Change in Serum Inflammatory and Immune Markers

    Time frame: Baseline, Week 8

    Change from baseline in serum levels of interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ).

  6. Change in Serum Gut-Brain Axis Regulatory Markers

    Time frame: Baseline, Week 8

    Change from baseline in serum levels of 5-hydroxytryptamine (5-HT), motilin (MTL), and substance P (SP).

  7. Change in Serum Intestinal Barrier Function Markers

    Time frame: Baseline, Week 8

    Change from baseline in serum levels of occludin, zonula occludens-1 (ZO-1), and lipopolysaccharide (LPS).

  8. Change in Serum Digestive Enzyme Levels

    Time frame: Baseline, Week 8

    Change from baseline in serum levels of pepsin, trypsin, and lipase.

  9. Change in Gut Microbiota Composition

    Time frame: Baseline, Week 8

    Change from baseline in gut microbiota diversity (alpha and beta diversity) and taxonomic composition at phylum and genus levels, assessed by 16S rRNA sequencing of fecal samples.

Study contacts

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

Ying Jin, Doctor

CONTACT

[email protected]

+86 18336086291

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Safety and Efficacy of Probiotics for Constipation Relief in Adults: A Randonmized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 17, 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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