Washed Microbiota Transplantation for Food Intolerance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: washed microbiota transplantation.
- Who it may be relevant to
- Registry conditions: Food Intolerance. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Procedure washed microbiota transplantation
The prepared microbiota suspension was infused into the patients' gut.
Primary outcome measures
- change of weight and height [Time frame: baseline, 4 weeks, 12 weeks post transplantation]
- change of the Gastrointestinal Symptom Rating Scale(GSRS) [Time frame: baseline, 4 weeks, 12 weeks post transplantation]
Secondary outcome measures (3)
- change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin [Time frame: baseline, 12 weeks post transplantation]
- the difference of the gut microbiota composition before and after washed microbiota transplantation [Time frame: baseline, 12 weeks post transplantation]
- the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 [Time frame: 12 weeks post transplantation]
Eligibility criteria
Inclusion criteria
- Food intolerance occurs through laboratory examination of at least two main foods
- Underwent washed microbiota transplantation.
Exclusion criteria
- Expected survival time <3 months;
- Women who are pregnant or breastfeeding;
- Other patients deemed not suitable for enrollment by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affi — Nanjing
Identifiers
NCT: NCT07190183 · WMT-FI