Study on the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Functional Gastrointestinal Disorders
This study is designed to explore the efficacy and safety of fecal microbiota transplantation (FMT) with different delivery routes for patients with functional gastrointestinal disorders (FGIDs). The response to FMT varies greatly, which is related to donor selection, administration route, individual patient characteristics and microbiota compatibility. This single-center, prospective randomized controlled trial plans to enroll 200 FGID patients refractory to conventional medications from OCT 2026 to OCT 2029. Eligible participants will be randomized into a conventional medication group or an FMT group; the FMT group will be further randomized into three subgroups according to transplantation routes: oral capsule, nasojejunal tube and colonoscopic administration. Clinical data, laboratory, imaging and endoscopic results will be collected. Gut microbiota and metabolites will be analyzed before and after treatment. Clinical efficacy and safety will be evaluated at week 12.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yanyun Fan, PhD
- Telefonní číslo: +86 592 2291429
- E-mail: fanyanyun@xmu.edu.cn
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
1: Aged 1865 years, regardless of gender;
2: Meeting the Rome IV diagnostic criteria (independently confirmed by two physicians with associate-senior title or above), including subtypes of irritable bowel syndrome: IBS-D (diarrhea-predominant), IBS-C (constipation-predominant), and IBS-M (mixed-type).
3: Patients with functional constipation (excluding defecatory disorder-related constipation), functional diarrhea, or functional bloating, who have poor response to or intolerance of at least one conventional pharmacotherapy (e.g., antispasmodics, antidiarrheals, osmotic laxatives), with a disease duration of ≥6 months.
4: Voluntarily participating in this study, signing a written informed consent form, and committing to comply with the study protocol.
Exclusion Criteria:
-
1: History of prior colectomy or planned surgery within 6 months
2: contraindications to colonoscopy (severe luminal stenosis, toxic megacolon, risk of perforation, etc.)
3: comorbid diagnoses: uncontrolled infectious enteritis, positive Clostridioides difficile test, intestinal ischemia, radiation colitis, active diverticular disease
4: ast or present history of active tuberculosis, active hepatitis B / hepatitis C / HIV infection opportunistic infections
5: severe systemic diseases: decompensated liver cirrhosis, NYHA Class Ⅲ-Ⅳ heart failure, renal insufficiency (eGFR<30 ml/min)
6: concomitant malignant tumor or lymphoma
7: severe immunodeficiency or long-term use of immunosuppressants or systemic glucocorticoids.
8: Pregnancy, lactation, or planned pregnancy within 6 months
9: allergy to FMT or study-related medications (laxatives, PPIs, etc.);
10: poor compliance, psychiatric disorders,or any other conditions deemed by investigators to render the subject unsuitable for participation in the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Oral capsule FMT group
Fecal microbiota transplantation via oral capsule combined with conventional symptomatic treatment for functional gastrointestinal disorders. |
FMT prepared from screened donor stool, administered by oral capsules, combined with conventional symptomatic treatment. |
|
Experimentální: Nasojejunal tube FMT group
Fecal microbiota transplantation delivered through nasojejunal tube combined with conventional symptomatic treatment for functional gastrointestinal disorders. |
FMT prepared from screened donor stool, infused via nasojejunal tube, combined with conventional symptomatic treatment. |
|
Experimentální: Colonoscopic FMT group
Fecal microbiota transplantation administered by colonoscopic catheter combined with conventional symptomatic treatment for functional gastrointestinal disorders. |
FMT prepared from screened donor stool, delivered through colonoscopic catheter, combined with conventional symptomatic treatment. |
|
Aktivní komparátor: Conventional medication group
Routine symptomatic drug treatment for functional gastrointestinal disorders without fecal microbiota transplantation. |
Routine symptomatic drugs for functional gastrointestinal disorders, without fecal microbiota transplantation. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinical response rate at week 12
Časové okno: 12 weeks after enrollment
|
The proportion of participants achieving clinical response (≥50% reduction in symptom score). Compare treatment responses across FGID subtypes (IBS-C, IBS-D, mixed IBS, functional constipation, functional diarrhea, functional bloating), and compare efficacy among three FMT administration routes. |
12 weeks after enrollment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adverse events of FMT
Časové okno: From FMT initiation to week 12
|
The type, frequency and severity of adverse events during transplantation, within 4 weeks (short-term) and within 12 weeks (long-term) after transplantation; compare route-related safety risks. |
From FMT initiation to week 12
|
|
Change in quality of life assessed by the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire
Časové okno: Baseline, week 12
|
The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire, ranging from 0 to 100. Higher scores indicate worse quality of life. Assessments will be performed at baseline and week 12. |
Baseline, week 12
|
|
Change in gut microbial alpha-diversity
Časové okno: Baseline, week 12
|
Gut microbial alpha-diversity (e.g., Shannon index, Chao1 index). Fecal samples will be collected for 16S rRNA sequencing. |
Baseline, week 12
|
|
Change in quality of life assessed by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
Časové okno: Baseline, week 12
|
The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, ranging from 0 to 112. Higher scores indicate worse quality of life. Assessments will be performed at baseline and week 12. |
Baseline, week 12
|
|
Change in gut microbial beta-diversity
Časové okno: Baseline, week 12
|
Gut microbial beta-diversity, reflecting overall dissimilarity of microbial community composition. Fecal samples will be collected for 16S rRNA sequencing. |
Baseline, week 12
|
|
Changes in relative abundance of beneficial taxa and microbiota engraftment
Časové okno: Baseline, week 12
|
Relative abundance of beneficial bacterial taxa and the degree of microbiota engraftment toward donor microbial profiles. Fecal samples will be collected for 16S rRNA sequencing. |
Baseline, week 12
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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- MR-35-26-081205
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