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A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 3 types of complex bacteria on improving bowel habit

A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 3 types of complex bacteria on improving bowel habit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010085
Enrollment
80
Registered
2024-12-27
Start date
2023-10-05
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

None listed

Interventions

Dietary Supplement : Biovita 3 or Placebo Capsules, 450 mg/capsule, 1 capsule/time, Once a day, Oral administration for 4 weeks

Sponsors

Kyung Hee University Oriental Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 65 2) Individuals classified as having functional constipation according to the Rome IV criteria 3) Individuals who voluntarily agreed to participate in the study and signed the informed consent form for the study

Exclusion criteria

Exclusion criteria: 1) Individuals diagnosed with irritable bowel syndrome 2) Individuals who have consumed substances that may affect constipation symptoms within the past two weeks, including: Medications for improving constipation symptoms, such as bulk-forming laxatives and stool softeners Herbal medicines for constipation, such as rhubarb, aloe, cannabis seed, or gleditsia seed Probiotic products for constipation, such as probiotics, fermented milk, and yogurt 3) Individuals diagnosed with or undergoing treatment for acute or chronic gastrointestinal diseases, such as Crohn’s disease, celiac disease, ulcerative colitis, or malignant tumors of the colon 4) Individuals who have undergone gastrointestinal or liver-related surgery (excluding appendectomy) 5) Individuals with a history of viral hepatitis, malignant tumors, mental disorders, or autoimmune diseases 6) Individuals following a diet for weight control 7) Diabetic patients with uncontrolled blood glucose levels despite medication (Fasting blood glucose levels of 126 mg/dL or higher while taking diabetes medication). 8) Hypertensive patients with uncontrolled blood pressure despite medication (Systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, while taking hypertension medication) 9) Individuals with AST, ALT, or creatinine (Cr) levels exceeding twice the normal range 10) Individuals with abnormal thyroid function 11) Pregnant or lactating women 12) Individuals with hypersensitivity to the test product or its ingredients, or with allergies to specific components 13) Individuals who participated in another clinical trial or human application trial within one month prior to this study 14) Individuals unable to read or with limited reading abilities. 15) Individuals deemed unsuitable for participation by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Frequency of bowel movements

Secondary

MeasureTime frame
Bowel habits;Quality of life

Countries

Korea, Republic of

Contacts

Public ContactMin Kyung Bok

Research Institute of Medical Nutrition

yoccobbong03@naver.com+82-2-969-7715

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 25, 2026