Probiotic Intervention for Gut Function

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

The effect of probiotics on gut function in healthy subjects.

Study Overview

• Status: Recruiting
• Conditions: Gut Function
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangjun Meng, MD; Phone Number: +86 021-53315134; Email: xiangjunmeng@aliyun.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai 9th People's Hospital
    • Contact: Xiangjun Meng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; Two capsules per day for 8 weeks	Dietary supplement: Probiotics; Capsule
Placebo Comparator: Placebo; Two capsules per day for 8 weeks	Dietary supplement: Placebo; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel movements	Reduction of the number of bowel movements	8 weeks

Collaborators and Investigators

• Sponsor: Probi AB
• Investigators: Principal Investigator: Xiangjun Meng, MD, Shanghai 9th People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PEC19132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No