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Effect of Ursodeoxychoil Acid in Functional Dyspeptic Patients with Small Intestinal Bacterial Overgrowth

Effect of Ursodeoxychoil Acid (URUSA) in Functional Dyspeptic Patients with Small Intestinal Bacterial Overgrowth: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0004910
Enrollment
24
Registered
2020-04-10
Start date
2019-07-22
Completion date
Unknown
Last updated
2020-04-21

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

Conditions

None listed

Interventions

Drug : The UDCA group received UDCA 100 mg three times a day for two months, and the non-administered group was observed for two months without intervention.

Sponsors

Ajou University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The Rome IV criteria define FD as one of four symptoms (postprandial fullness, early satiation, epigastric pain, epigastric burning) that occurred at least six months before diagnosis and persisted for the last three months. In addition, examinations involving endoscopy should reveal no structural abnormalities to explain these symptoms.

Exclusion criteria

Exclusion criteria: Patients with FD were excluded from this study if they had a history of i) gastrointestinal ulcers or inflammatory bowel diseases such as Crohn's disease or ulcerative colitis; ii) gastrectomy or intestinal resection (except appendectomy); or iii) viral liver disease (types A, B, C), cirrhosis, or any cancers, as well as iv) blood tests whose serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) or gamma-glutamyltransferase (GGT) levels were more than three times the normal range or whose serum creatinine levels were more than 1.5 times the normal range; v) chronic renal failure, congestive heart failure, and thyroid disease; vi) persistent alcohol consumption (at least four bottles of soju per week, i.e., at least 240g of alcohol per week); or vii) severe biliary obstruction.

Design outcomes

Primary

MeasureTime frame
The questionnaire about dyspepsia measured each patient’s Nepean dyspepsia index-K (NDI-K) and Small intestinal bacterial overgrowth prevalence.

Secondary

MeasureTime frame
Adverse events

Countries

Korea, Republic of

Contacts

Public ContactKYUNAM KIM

Ajou University Hospital

Outcome results

None listed

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