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

A 8-week randomized, double-blind, placebo-controlled trial to improve intestinal health (constipation and gut microbiota)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009026
Enrollment
30
Registered
2023-12-08
Start date
2022-07-04
Completion date
Unknown
Last updated
2023-12-19

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 : [Test product] - Test product: Probiotics - Main raw material: Lactobacillus rhamnosus - Appearance and dosage form: White hard capsule/hard capsule containing the contents - Cont

Sponsors

Ildong Bioscience
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Data collection and analysis by questionnaires

Secondary

MeasureTime frame
Statistical analysis for metagenome data;Statistical analyses for metabolome data

Countries

Korea, Republic of

Contacts

Public Contacthyeji kwon

Seoul Songdo Hospital

khj_917@hanmail.net+82-2-2250-7849

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026