Probiotic Intervention for Gut Function

Probi AB

Status: Completed

Conditions: Gut Function

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT05155449

PEC19132

Details and patient eligibility

About

The effect of probiotics on gut function in healthy subjects.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Description:

Two capsules per day for 8 weeks

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

Two capsules per day for 8 weeks

Treatment:

Dietary Supplement: Placebo