CClinicalTrials.gg
CompletedNCT05155449Updated Jun 18, 2025

Probiotic Intervention for Gut Function

An interventional study of Probiotics and Placebo in Gut Function, sponsored by Probi AB. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The effect of probiotics on gut function in healthy subjects.

02

Conditions studied

  • Gut Function
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Probiotics

    Two capsules per day for 8 weeks

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    Two capsules per day for 8 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics

    Capsule

  • Dietary supplementPlacebo

    Capsule

05

What researchers measure

Primary outcomes

  1. Bowel movements

    Reduction of the number of bowel movements

    Time frame: 8 weeks

06

Study locations

1 site
  • Shanghai 9th People's Hospital
    Shanghai, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05155449
Lead sponsor
Probi AB
Responsible party
Sponsor
First posted
Dec 13, 2021
Start date
Feb 8, 2023
Primary completion
Jun 3, 2024
Completion
Jun 3, 2024
Last update
Jun 18, 2025

Study contacts

Xiangjun Meng, MD
principal investigator · Shanghai 9th People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion