Diarrhea predominant irritable bowel syndrome (IBS-D)
Conditions
Interventions
A : Oral administration of Salacia extract tablets (120mg b.i.d, daily) to subjects for 4 weeks
B : Oral administration of placebo to subjects for 4 weeks
Sponsors
The Jikei University School of Medicine
Kyoto Prefectural University Isshi Gastrointestinal Clinic Uchiyama Icho-ka Clinic Fuji City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as diarrhea predominant irritable bowel syndrome by the Rome-III criteria
Exclusion criteria
Exclusion criteria: 1. Patients with lactation, pregnancy or possibility of pregnancy. 2. Patients with surgical history of gastrointestinal tract 3. Patients with active inflammatory bowel disease 4. Patients with Celiac disease 5. Patients with organ failure 6. Patients who were administered antibiotics within 4 weeks 7. Patients who took materials containing Salacia extract within 4 weeks 8. Other patients who are deemed inappropriate by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of increase of the genus Bifidobacterium proportion from baseline to 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of abdominal pain after 4 weeks Improvement of IBS-Severity Index score Improvement of IBS-QOL score Improvement of Bristol stool scale Composition of gut microbiota (amount of increase of the genus Veillonella proportion from baseline to 4 weeks, amount of increase of the genus Lactobacillus proportion from baseline to 4 weeks) [Exploratory outcomes] Improvement of SF-8 (QOL score) Improvement of HADS score Microbiota diversity (Shannon index, Chao1 index, weighted and unweighted UniFrac distances) Prediction of the functional compositon of a metagenome using PICRUSt Improvement of IBS-SI score in stratified analysis by each of the following 6 factors (more/less) at baseline Correlation coefficient between the improvement of IBS-SI score and each increment of the following 6 factors at baseline to 4 weeks [Six factors] a. the genus Bifidobacterium (%) b. the genus Veillonella (%) c. the genus Lactobacillus (%) d. the phylum Firmicutes : Bacteroides ratio e. Shannon index f. Chao1 index | — |
Countries
Japan
Contacts
Public ContactHiroto Furuhashi
The Jikei University School of Medicine Department of Endoscopy
Outcome results
None listed