Probiotic Intervention for Gut Function

NCT05155449 | Completed

• 1 other identifier: PEC19132
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of probiotics on gut function in healthy subjects.

Conditions

Gut Function

Outcome Measures

Primary Outcomes (1)

• Bowel movements

  Reduction of the number of bowel movements

  8 weeks

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Two capsules per day for 8 weeks

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Two capsules per day for 8 weeks

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Capsule

Probiotics

Placebo DIETARY_SUPPLEMENT

Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Probi AB: lead

Study Sites (1)

Shanghai 9th People's Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Xiangjun Meng, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: February 8, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)