Probiotic Intervention for Gut Function

NCT ID: NCT05155449

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2024-06-03

Brief Summary

The effect of probiotics on gut function in healthy subjects.

Conditions

Gut Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotics

Two capsules per day for 8 weeks

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Capsule

Placebo

Two capsules per day for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Capsule

Interventions

Probiotics

Capsule

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Capsule

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Probi AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangjun Meng, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 9th People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

Locations

Shanghai 9th People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

PEC19132

Identifier Type: -

Identifier Source: org_study_id