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OpenTrials
Completed

NCT Number: NCT05155449

Probiotic Intervention for Gut Function

The effect of probiotics on gut function in healthy subjects.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai 9th People's Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18 and 65 years
  • BMI between 18.5 and 27.9 kg/m²
  • Subjects having ≥ 3 bowel movements per day
  • Subject not satisfied with their bowel habits
  • Subject having frequent stools during more than 4 weeks
  • For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
  • Subjects agreeing to keep their dietary and life habits unchanged throughout the study
  • Good general and mental health within the opinion of the investigator
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by a dated and signed ICF

Exclusion criteria

  • Suffering IBS according to Rome IV criteria, chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
  • Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
  • Suffering from a severe chronic disease or GI disorders found to be inconsistent with the conduct of the study by the investigator
  • Intake of antibiotics within 8 weeks prior to the start of the study
  • With regular intake of probiotics within four weeks prior to V1 visit
  • Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit
  • Suspected alcohol or substance abuse
  • Use of medications other than contraceptives or prescribed medication after consulting with the investigator
  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
  • With a known gluten intolerance, milk protein allergy
  • With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients
  • Pregnant or lactating women or intending to become pregnant within 3 months ahead
  • With significant change in food habits or in physical activity in the 3 months before the V1 visit
  • With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator
  • Having a lifestyle deemed incompatible with the study according to the investigator
  • Currently participating in another clinical study, has done so in the past 30 days or being in the exclusion period of a previous clinical trial
  • Under legal protection (guardianship, wardship) or deprived from his/her rights following administrative or judicial decision
  • Presenting a psychological or linguistic incapability to sign the informed consent or Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
  • Impossible to contact in case of emergency

Treatment and study plan

Probiotics

Dietary Supplement

Capsule

Placebo

Dietary Supplement

Capsule

Primary outcomes

  1. Bowel movements

    Time frame: 8 weeks

    Reduction of the number of bowel movements

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of Probiotics on Gut Function in Healthy Chinese Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2021
Registry last updated
Jun 18, 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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