Food Intolerance
Conditions
Keywords
washed microbiota transplantation, food intolerance, fecal microbiota transplantation, gut microbiota
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREwashed microbiota transplantation
The prepared microbiota suspension was infused into the patients' gut.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Food intolerance occurs through laboratory examination of at least two main foods 2. Underwent washed microbiota transplantation.
Exclusion criteria
1. Expected survival time \<3 months; 2. Women who are pregnant or breastfeeding; 3. Other patients deemed not suitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of weight and height | baseline, 4 weeks, 12 weeks post transplantation | Weight and height will be combined to report BMI in kg/m\^2. |
| change of the Gastrointestinal Symptom Rating Scale(GSRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin | baseline, 12 weeks post transplantation | Blood test |
| the difference of the gut microbiota composition before and after washed microbiota transplantation | 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. |
| the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | 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.). |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui, PhD
Outcome results
None listed