A 8-week randomized, double-blind, placebo-controlled trial to improve intestinal health

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0009026
• Lead Sponsor: Ildong Bioscience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-28
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Adult men and women between the ages of 19 and 65
- If you have hard or lumpy stools more than 1 time out of 4, or soft stools less than 1 time out of 4 according to Rome IV standards.

Exclusion Criteria

- Those diagnosed with constipation other than constipation-type irritable bowel syndrome
- Those with a history of gastrointestinal surgery (excluding appendectomy and cesarean section)
- If there are warning symptoms such as rectal bleeding or weight loss
- If you currently have a disease that may affect the evaluation of drug efficacy in the digestive system (e.g., organic disease such as colitis, colon cancer, etc.) or have had it within the past 2 years
- Probiotics, prebiotics, synbiotics, antibiotics, corticosteroids, antidepressants, antihistamines, non-steroidal anti-inflammatory drugs, and other drugs that affect intestinal motility (laxatives, antidiarrheals, intestinal motility stimulants, and antispasmodics) within the previous 2 weeks. Those who took it
- If you have concomitant diseases such as liver cancer or cirrhosis, chronic renal failure, congestive heart failure, or thyroid disease
- Pregnant women, lactating women, and women of childbearing potential who plan to become pregnant or breast-feed during the participation period.
- Patients with mental illnesses such as depression, schizophrenia, alcoholism, drug addiction, etc.
- Those who have hypersensitivity to the test product or ingredients contained in the test product or are allergic to a specific ingredient
- Those who participated in another clinical trial within the last 3 months
- Subjects who, in the opinion of the researcher, are judged to be unable to comply with the test requirements or are otherwise deemed unsuitable by the doctor.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data collection and analysis by questionnaires

Secondary Outcome Measures

Name	Time	Method
Statistical analysis for metagenome data;Statistical analyses for metabolome data