Validation study for intestinal functions and anti-inflammatory effect in heathy Japanese adults: a double-blind randomized controlled trial

Not Applicable

• Conditions: Healthy adults

• Registration Number: JPRN-UMIN000017794
• Lead Sponsor: ORTHOMEDICO, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-03
• Study Completion: 2015-08-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, disease of digestive system (including ulcerative colitis, gastric ulcer, Diverticular Disease of the Colon, etc) or other chronic disease 3. Currently taking medicines, herbal medicines 4. Usually taking yogurt, oligosaccharide or lactic acid bacteria. 5. Allergic to medicines or foods related to the test food of this trial 6. Usually taking supplements and nutrient function foods 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating in this trial by physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal bacterial flora

Secondary Outcome Measures

Name	Time	Method
CAS-MT Bristol stool scale High sensitivity CRP