Gut health Digestive System
Conditions
Interventions
Participants were randomized 1:1 to receive either:
1. Biotra® supplementation (active treatment) OR
2. Placebo (control group)
Both were administered orally daily (two at night, one in the morning)
Sponsors
Innovation Labo Sciences Co., Ltd
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult men or women aged 21 to 65 years (inclusive) 2. Individuals with general symptoms of constipation who met the ROME III criteria for functional constipation 3. Body Mass Index (BMI) less than 35 kg/m² 4. Female participants of child-bearing potential were required to: Use an approved method of contraception, and have a negative pregnancy test at screening 5. Female participants of non-childbearing potential had to be amenorrheic for at least 1 year or have undergone hysterectomy and/or bilateral oophorectomy 6. Ability and willingness to provide written informed consent 7. Willingness to comply with all trial procedures and study visits 8. Ability to understand the potential risks and benefits of participation 9. Availability for the full study duration (approximately 6 weeks including follow-up)
Exclusion criteria
Exclusion criteria: 1. Constipation due to organic or neurological lesions 2. History of pathological bowel diseases, including inflammatory bowel disease (IBD) or colon cancer 3. Abnormal liver or renal function 4. Use of any prebiotic, probiotic, or laxative supplements within 4 weeks prior to study start 5. Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the past 4 weeks 6. Known allergy to soy milk or other ingredients of the test product 7. History of alcoholism or drug abuse 8. Pregnant or lactating women 9. History of anxiety, depression, or recent intake of psychotropic drugs 10. Any other medical or personal condition that, in the investigator’s opinion, could jeopardize the study outcomes
Countries
Japan
Contacts
Public ContactAki Honda
Outcome results
None listed