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A Randomized, Double-Blind, Placebo-Controlled Crossover Study on the Effects of Foods Containing Fermented Plant Extracts on Bowel Movements and Intestinal Flora

Phase 1
Conditions
Male and Female, aged 20-64 years Mild constipation (2-4 bowel movements per week) Hard stools, with pain during defecation Mild constipation that has been present for at least 6 months
Registration Number
JPRN-UMIN000024111
Lead Sponsor
Hokkaido Pharmaceutical University School of Pharmacy
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Individuals with a serious illness, such as diabetes, brain dysfunction, liver disease, kidney disease, heart disease, peripheral vascular disorders, and digestive system disease or those with a history of such illnesses (2) Individuals currently undergoing treatment for a disease (3) Individuals who have undergone surgery on the digestive tract (4) Individuals with food or drug allergies (5) Individuals routinely using medicinal agents, foods, beverages, or supplements thought to improve constipation (6) Individuals who drink an excessive amount of alcohol daily or who cannot abstain from alcohol on the day before the study (7) Individuals engaged in intense sports or dieting (8) Individuals who are pregnant or who plan to become pregnant or are breastfeeding during the trial period (9) Individuals who have participated in a clinical trial of an investigational drug or a long-term clinical study of a food or cosmetic product (excluding single-dose studies) within the past 4 weeks and individuals who are currently participating in a clinical study (10) Individuals judged as being ineligible to participate by the investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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