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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yanyun Fan, PhD
- Numéro de téléphone: +86 592 2291429
- E-mail: fanyanyun@xmu.edu.cn
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical response rate at week 12
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adverse events of FMT
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MR-35-26-081205
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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