Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Location status: Recruiting
NCT Number: NCT07190183
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.
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Observational
Nanjing, Jiangsu, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The prepared microbiota suspension was infused into the patients' gut.
Other names: fecal microbiota transplantation
Time frame: baseline, 4 weeks, 12 weeks post transplantation
Weight and height will be combined to report BMI in kg/m^2.
Time frame: baseline, 4 weeks, 12 weeks post transplantation
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, 12 weeks post transplantation
Blood test
Time frame: baseline, 12 weeks post 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: 12 weeks post transplantation
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.).
Contact information is provided by the study sponsor or research team.
Bota Cui, PhD
CONTACT
Faming Zhang, PhD
CONTACT
The Second Hospital of Nanjing Medical University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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