The Role of Neuromodulators in Refractory Functional Dyspepsia

Shanghai Jiao Tong University

Status: Unknown

Conditions: Functional Gastrointestinal Disorders; Dyspepsia; Antidepressant Discontinuation Syndrome; Antidepressant Drug Adverse Reaction

Treatments: Drug: Deanxit

Study type: Interventional

Funder types: Other

Identifiers

NCT05099913

RJYYXHNK

Details and patient eligibility

About

The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia

Full description

Functional dyspepsia (FD) is a prevalent disease combined with emotional disorders. Antidepressants are beneficial in the treatment of refractory FD, while for the long-term use of antidepressants, it could lead to withdrawal syndrome or other adverse events.

Refractory FD patients were unsatisfied with the regular first-line anti-acid treatment. However, many patients were worried about taking antidiepressants, even though guideline has recommended antidepressant use in FD. In our study, we would use low-dose and short-term antidepressant in refractory FD patients, and investigate whether short-term antidepressants application would improve therapeutic efficacy and minimize antidepressant withdrawal of FD patients.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-70 years old;
• education level higher than middle school;
• met the Rome IV criteria for FD; absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months;
• absence of Helicobacter pylori infection;
• signed written informed consent for participation in the study.

Exclusion criteria

• evidence of organic digestive diseases;
• diabetes, cancer and other diseases might affect GI function;
• pregnancy, lactation or breastfeeding;
• a history of allergic reaction to any of the drugs used in the study;
• participation in other clinical trials in the previous 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

2-week group

Experimental group

Description:

Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand.

Treatment:

Drug: Deanxit

4-week group

Experimental group

Description:

Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics).

Treatment:

Drug: Deanxit