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Recruiting

NCT Number: NCT07081100

Probiotics and Non-Organic Gastrointestinal Improvement

To verify the improvement of gastrointestinal function in patients with non-organic gastrointestinal dysfunction after 4 weeks of intervention with compound probiotics.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University

Suzhou, Jiangsu, 215200, China

Location status: Recruiting

Location contact

Ying Jin, Doctor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Voluntarily sign the informed consent form and agree to participate in the study.
  • Ability to complete the study according to the trial protocol requirements.
  • Aged 18-65 years.
  • Clinical diagnosis of non-organic gastrointestinal dysfunction (e.g., functional dyspepsia, functional constipation) without other serious organic diseases.

Exclusion criteria

  • Use of drugs affecting intestinal flora (antibiotics, probiotics, intestinal mucosal protectants, herbal medicines, etc.) for >1 week within 1 month prior to screening.
  • Short-term use of products with functions similar to the investigational product, which may interfere with result interpretation.
  • Antibiotic use during the study period.
  • History of severe systemic diseases or malignancies.
  • Allergy to any ingredient in the compound probiotic freeze-dried powder used in the trial.
  • Pregnancy, lactation, or plans for pregnancy in the near future.
  • Inability to participate due to personal reasons.
  • Other conditions deemed unsuitable by the investigators.

Treatment and study plan

Probiotic group

Dietary Supplement

Participants took a freeze-dried probiotic powder every day, half an hour after a meal.

Primary outcomes

  1. Improvement of gastrointestinal function in study participants

    Time frame: 4 weeks

    The severity of gastrointestinal symptoms was assessed by the Gastrointestinal Symptom Rating Scale (GSRS). Each item is scored from 1 (no symptoms) to 7 (extremely severe symptoms. Higher scores indicate worse gastrointestinal dysfunction.

Study contacts

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

Ying Jin, Doctor

CONTACT

[email protected]

13375163966

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Study on the Effect of Probiotics on Improving Gastrointestinal Function in Patients With Non-organic Gastrointestinal Dysfunction

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jul 31, 2025

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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