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)

Not Applicable

• Conditions: Healthy volunteer

• Registration Number: JPRN-UMIN000046832
• Lead Sponsor: Japan Physicians Association

Brief Summary

This study evaluated the accuracy of diarrhea-type and constipation-type scores calculated using data on gut microbiota. As results, AUC between patients with IBS who having diarrhea symptoms and healthy subjects was 0.599, and AUC between patients with IBS who having constipation symptoms and healthy subjects was 0.645, both of which were lower than the hypotheses (AUC > 0.7). It seemed to be difficult to utilize these indexes to discriminate subjects with diarrhea or constipation symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-10
• Study Completion: 2022-05-16
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified