Functional dyspepsia Dysbiosis Functional dyspepsia
Conditions
Interventions
24 FMT capsules (prepared using 50 grams of donor stool), administered orally over two days (6 capsules twice daily). Capsules were manufactured using freeze-dried donor feces, encapsulated in enteric
Experimental Drug,Placebo Comparator Drug
FMT,Placebo
Sponsors
Thailand Science Research and Innovation Fundamental Fund 2025
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years 2. Diagnosed with functional dyspepsia according to Rome IV criteria 3. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1) pregnancy or breastfeeding; (2) severe comorbid conditions including end-stage renal disease requiring dialysis, advanced liver cirrhosis (Child-Pugh class C), immunodeficiency (e.g., AIDS), active malignancy, inflammatory bowel disease, severe psychiatric disorders, or a history of cerebrovascular or cardiovascular disease; (3) prior abdominal surgery; (4) immunocompromised status or recent use (within the past 3 months) of immunosuppressive agents including antineoplastics, monoclonal antibodies, anti-TNF agents, calcineurin inhibitors, or mycophenolate mofetil; (5) use of probiotics, probiotic supplements (e.g., yogurt or fermented foods), or unwillingness to discontinue these for the duration of the study; (6) use of dyspepsia-related medications within one month prior to enrollment; (7) ongoing participation in other investigational drug studies; (8) abnormal laboratory findings or gastrointestinal endoscopy results; (9) current or recent (within 6 weeks) treatment for Helicobacter pylori infection, based on evidence that symptom resolution occurs in over 92% of cases by six weeks post-eradication; (10) absence of prior treatment for functional dyspepsia in the preceding month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference in symptom improvement between the FMT and placebo groups 12 week SODA score | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life related to functional dyspepsia 12 week EQ-5D questionnaire,Incidence and nature of adverse events related to FMT 12 week questionaire,microbiota analysis 12 week alpha and beta diversity | — |
Countries
Thailand
Contacts
Public ContactPhubordee Bongkotvirawan
Faculty of Medicine, Thammasat University
Outcome results
None listed