An observational study in Food Intolerance, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by The Second Hospital of Nanjing Medical University · Observational
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.
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.
34 studies on the registry are indexed under Food Intolerance; 6 are open to participants now.
Browse Food Intolerance studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
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Patients with food intolerance receiving WMT will be enrolled.
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Exclusion Criteria:
patients undergoing washed microbiota transplantation who were diagnosed as food intolerance according to laboratory examination
Procedure: washed microbiota transplantation
The FI did not undergo washed microbiota transplantation
The prepared microbiota suspension was infused into the patients' gut.
Also known as: fecal microbiota transplantation
change of weight and height
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 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.
Time frame: baseline, 4 weeks, 12 weeks post transplantation
change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin
Blood test
Time frame: 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.
Time frame: 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.).
Time frame: 12 weeks post transplantation
Plan to share: No
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The Second Hospital of Nanjing Medical University