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The efficacy and mechanism of Medilac-s in the treatment of functional dyspepsia based on the Microbiota-Gut-Brain Axis: a prospective, block randomized, double-blind, placebo-controlled study

The efficacy and mechanism of Medilac-s in the treatment of functional dyspepsia based on the Microbiota-Gut-Brain Axis: a prospective, block randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073021
Enrollment
Unknown
Registered
2023-06-29
Start date
2023-12-21
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Functional dyspepsia

Interventions

Group 1:Esomeprazole 20mg once a day, Medilac-s 0.5g three times a day. Patients were treated for 28 days.
Group 2:Esomeprazole 20mg once a day, placebo 0.5g three times a day. Patients were treated for 28 days.

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years; 2. Diagnosed as functional dyspepsia according to the Rome IV standard; 3. Volunteer to participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Positive Hp infection was confirmed by 13C urea breath test, rapid urease test, etc.; 2. Using probiotics, prokinetic drugs, immunosuppressive drugs, or antibiotics within the past month; 3. Severe heart, lung, liver, and kidney diseases; 4. Diabetes and malignant tumor; 5. Previous history of abdominal surgery; 6. Pregnant and lactating women; 7. In addition to the above, researchers have determined that patients are not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
7-point Global Overall Symptom Scale score at 4 weeks of treatment;Fecal microbiota;

Secondary

MeasureTime frame
Short chain fatty acids in feces;Neurotransmitter in blood;7-point Global Overall Symptom Scale score at 1 week, 2 weeks, and 3 weeks of treatment;Functional digestive disease quality of life questionnaire at 4 weeks of treatment;Side effects;

Countries

China

Contacts

Public ContactXu Shu

The First Affiliated Hospital of Nanchang University

jxmushx@126.com+86 135 1791 0752

Outcome results

None listed

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