Budesonide as a Treatment for Functional Dyspepsia

PHASE4RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
Functional Dyspepsia
Interventions
DRUG

budesonide

During an 8-week treatment period, patients will receive 9 mg of Budesonide daily, administered orally in enteric-coated capsules. Following this period, participants will undergo a gradual dose reduction to minimize the risk of adrenal insufficiency: 6 mg daily for 2 weeks, followed by 3 mg daily for another 2 weeks before discontinuing treatment.

DRUG

Mannitol

During an 8-week treatment period, patients will receive 9 mg of Mannitol daily, administered orally in enteric-coated capsules as placebo control. Following this period, participants will undergo a gradual dose reduction as is the case in the experimental group: 6 mg daily for 2 weeks, followed by 3 mg daily for another 2 weeks before discontinuing treatment.

Trial Locations (1)

3000

RECRUITING

UZ Leuven, Leuven

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER