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A study of the effect of probiotics on the intestinal environment as a result of protein supplementation -A Randomized, Double-Blind, Placebo-Controlled trial

A study of the effect of probiotics on the intestinal environment as a result of protein supplementation -A Randomized, Double-Blind, Placebo-Controlled trial - A study of the effect of probiotics on the intestinal environment as a result of protein supplementation -A Randomized, Double-Blind, Placebo-Controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055574
Enrollment
60
Registered
2024-09-30
Start date
2024-09-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Healthy male who are age of at least 18 years of age 2.Subjects who continue or increase the intake of protein supplements to the specified dosage during the study food intake period.

Exclusion criteria

Exclusion criteria: 1.Subjects who have a current or past history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease. 2.Subjects who regularly use medicine that affect the gut microbiota such as Intestinal regulators, laxatives, etc. 3.Subjects who have lactose intolerance. 4.Subjects who are unable to discontinue foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc. during the study period. 5.Subjects whose daily protein intake is 3.0 g/kg body weight/day or more. 6.Subjects who have drug allergy, food allergy or medical history. 7.Individuals who participated in other clinical trials in the past 1 month or who are going to participate in other trials in this study period. 8.Subjects considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.

Design outcomes

Primary

MeasureTime frame
intestinal environment

Secondary

MeasureTime frame
fecal frequency, fecal characteristics, dietary survey, physical examination, skin gas, condition assessment, gastrointestinal symptoms

Countries

Japan

Contacts

Public ContactShuichi Machida

Juntendo University Graduate School of Health and Sports Science

machidas@juntendo.ac.jp0476-98-1001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026