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L'essai clinique NCT07190183 pour Intolérance alimentaire est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Washed Microbiota Transplantation for Food Intolerance
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT07190183 est un essai observationnel pour Intolérance alimentaire. Son statut actuel est : en recrutement. L'étude a débuté le 1 janvier 2025 et vise à recruter 100 participants. Dirigé par The Second Hospital of Nanjing Medical University, l'essai devrait être terminé d'ici le 31 décembre 2035. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 septembre 2025.
Résumé succinct
Food intolerance (FI) is an adverse reaction to food caused by non-immune mechanisms, mainly related to digestive enzyme deficiencies (e.g. lactase deficiency), metabolic abnormalities (e.g. impaired absorption of fructose) or toxicity of food components (e.g. histamine). Unlike immune-mediated food allergy, FI symptoms are usually delayed (hours to days after ingestion) and mild, but are difficult to diagnose and manage clinically due to the complexity and variety of mechanisms that affect approximately 20% of the world's population.
Description détaillée
The gut microbiota of food intolerance (FI) is different. The widespread use of artificial sweeteners (e.g. saccharin) can induce metabolic disorders by altering the structure of the intestinal flora, e.g. animal experiments have shown that the abundance of pathogenic bacteria (e.g. Bacteroides vulgatus) in the intestinal tract of mice ingesting saccharin was significantly increased, whereas the abundance of Akkermansia muciniphila was decreased, which led to impaired glucose tolerance and abnormal fat absorption, and ultimately increased the risk of obesity and diabetes mellitus. ultimately increasing the risk of obesity and diabetes . In addition, sorbitol, as a low-calorie sugar alcohol, can trigger osmotic diarrhoea when ingested in excess, while antibiotics combined with a high-fat diet further disrupts intestinal flora balance (e.g., Clostridia depletion), decreases flora sorbitol dehydrogenase activity, and leads to persistent sorbitol metabolism disorders.
Titre officiel
Washed Microbiota Transplantation for Food Intolerance
Conditions
Intolérance alimentaireAutres identifiants de l'essai
- WMT-FI
Numéro NCT
Date de début (réel)
2025-01-01
Dernière mise à jour publiée
2025-09-24
Date de fin (estimée)
2035-12-31
Inscription (estimée)
100
Type d'essai
Observationnel
Statut
En recrutement
Mots clés
washed microbiota transplantation
food intolerance
fecal microbiota transplantation
gut microbiota
food intolerance
fecal microbiota transplantation
gut microbiota
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
The FI undergoing washed microbiota transplantation patients undergoing washed microbiota transplantation who were diagnosed as food intolerance according to laboratory examination | Transplantation de microbiote lavé The prepared microbiota suspension was infused into the patients' gut. |
The FI not undergoing washed microbiota transplantation The FI did not undergo washed microbiota transplantation | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
change of weight and height | Weight and height will be combined to report BMI in kg/m\^2. | baseline, 4 weeks, 12 weeks post transplantation |
change of the Gastrointestinal Symptom Rating Scale(GSRS) | GSRS is a 13-item test to make a comprehensive assessment of common gastrointestinal symptom and each item receives a value from 0 to 3, with higher value indicating worse gastrointestinal condition. | baseline, 4 weeks, 12 weeks post transplantation |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin | Blood test | baseline, 12 weeks post transplantation |
the difference of the gut microbiota composition before and after washed microbiota transplantation | The composition of the gut microbiota is evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism. | baseline, 12 weeks post transplantation |
the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.). | 12 weeks post transplantation |
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Sexes éligibles
Tous
- Food intolerance occurs through laboratory examination of at least two main foods
- Underwent washed microbiota transplantation.
- Expected survival time <3 months;
- Women who are pregnant or breastfeeding;
- Other patients deemed not suitable for enrollment by the investigator.
Partie responsable de l'essai
Faming Zhang, Investigateur principal, Professsor, Gastroenterology, The Second Hospital of Nanjing Medical University
Contact central de l'essai
Contact: Faming Zhang, PhD, 086-025-58509883, [email protected]
Contact: Bota Cui, PhD, 086-025-58509884, [email protected]
1 Centres de l'essai dans 1 pays
Jiangsu
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
Faming Zhang, PhD, Contact, 086-025-58509883, [email protected]
En recrutement