None listed
Conditions
Interventions
Dietary Supplement : [Test group]
(Group 2) Group 1 Enterococcus faecalis lactic acid bacteria (EF-2001)
(Group 3) Group 1 Lactobacillus plantarum Lactobacillus mycelium (beLP1)
- Formulation: Powder
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? men and women between the ages of 19 and 70 ?A person with diarrhea-type irritable bowel syndrome who has had at least 2 abdominal pain with at least 4 VAS points in at least 2 weeks of screening period, according to the Roman standard ROME IV criterion (2016) * ROME IV criteria (2016) Abdominal pain at least once a week began at least six months ago and has been present for the last three months, and the abdominal pain satisfies more than two of the following three 1) associated with bowel movements 2) accompanied by changes in the number of bowel movements 3) accompanied by changes in stool form ? A person who has undergone colonoscopy within 5 years based on visit 1 and has been confirmed to have no organic abnormalities in the large intestine (with relevant data if conducted by another institution) ? Among the above subjects, those who agreed to participate in this study
Exclusion criteria
Exclusion criteria: ? a person who is pregnant or nursing ? A person with a history of being hospitalized for mental illness within three years on the basis of visit 1 ? A person with a history of drug/alcohol abuse within 3 years of visit 1 ? A person who has a history of taking antipsychotic drugs within 3 months on the basis of visit 1 ? A person with a history of small or large intestine surgery within 5 years of visit 1 (excluding anusitis, hernia surgery, cholecystectomy, and cesarean section) ? An organic disease in the large intestine or small intestine and a disease that can affect bowel movement (inflammatory bowel) A person diagnosed with a disease, malabsorption, etc. (except for colon polyps) ? A person who has a history of being diagnosed with and treated malignant tumors within 5 years based on visit 1 (if determined to be completely cured, participation is possible) ? Persons with uncontrolled severe metabolic disease, cardiovascular disease, endocrine disease, kidney disease, thyroid disease ? A person whose AST or ALT is more than twice the normal upper limit of the implementing agency ? A person whose creatinine is more than twice the upper limit of the institution's normal limit ? A person who has a history of taking antibiotics or drugs that may affect probiotics, prebiotics, postbiotics, and intestinal function within four weeks of visit 1 (but Loperamide is allowed to be taken as a rescue medication, but the dose is recorded) (Patient contraindications: antidiarrheals, laxatives, gastrointestinal motility stimulants, antibiotics (within 3 months from the start of the study), steroids (within 1 month from the start of the study), pain relievers, anticancer drugs, probiotics, postbiotics, prebiotics) ? A person who has clearly changed his or her eating habits within four weeks of visit 1 (change from omnivore to vegetarian or from vegetarian to omnivore) ? Other clinicians have judged that participation in this study is not appropriate ? Those who did not agree with this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS-AR(Irritable Bowel Syndrome-Adequate relief) | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS-SSS(Irritable Bowel Syndrome-Symptom Severity Score);IBS-QOL(Irritable Bowel Syndrome-Quality of Life);Symptom diary;HADS (Hospital Anxiety-Depression Scale);Changes of fecal microbiome | — |
Countries
Korea, Republic of
Contacts
Public ContactChanghwan Choi
Chung-Ang Univerisity Hospital
Outcome results
None listed