Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study)

Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study) - Prediction accuracy of algorism for entric microbiota scoring to discriminate constipation or diarrhea symptoms in healthy subjects and patients with constipation, diarrhea, or mixed-type irritable bowel syndrome (PALETTE-IBS study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046832

Enrollment

Registered

2022-02-10

Start date

2022-03-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Healthy volunteer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. male and female who are aged of 20 years or older and younger than 60 years at giving their consent 2. healthy individuals (those who are not regularly visiting hospitals or taking prescription drugs on a regular basis at giving their consent) 3. subjects whose first language is Japanese. 4. subjects who give their consent to participate in this study by written form

Exclusion criteria

Exclusion criteria: 1. subjects who have taken antibiotics or antibacterial drugs within the last 3 months before giving their consent 2. subjects who have taken antidepressants, antipsychotics, or anxiolytics on a daily basis within the last 3 months before giving their consent (except medication when needed) 3. subjects who have IBS symptoms based on Rome IV criteria, or have a history of IBS 4. subjects with chronic constipation or diarrhea 5. subjects with digestive disorders such as inflammatory bowel disease 6. subjects with history of major digestive system surgery such as gastrectomy, gastrointestinal suture, intestinal resection, etc. 7. subjects with a history of cancer of the digestive system. 8. subjects who are pregnant, breastfeeding, possibly pregnant, or planning to become pregnant 9. subjects who need a regal representative 10. subjects who are judged by the responsible investigator or sub-investigator to be inappropriate for participation in the study.

Design outcomes

Primary

Measure	Time frame
Area under the ROC curve to discriminate diarrhea or constipation symptoms by diarrhea-type and constipation-type scores	—

Secondary

Measure	Time frame
1. Sensitivity and specificity for discrimination of diarrhea or constipation symptoms by diarrhea-type and constipation-type scores at cutoff value 2. Optimal cutoff values for discrimination of diarrhea or constipation symptoms by diarrhea-type and constipation-type scores 3. gut microbial metagenome in healthy subjects and patients with diarrhea-type, constipation-type, and mixed-type IBS	—

Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken, Inc. Clinical Study Support Division

takayama@soiken.com03-3295-1350

Outcome results