Actively Recruiting
Washed Microbiota Transplantation for Food Intolerance
Led by The Second Hospital of Nanjing Medical University · Updated on 2025-09-24
100
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Food intolerance is a common condition caused by non-immune reactions to food, such as enzyme deficiencies or metabolic issues, affecting about 20% of people worldwide. This research investigates how differences in gut microbiota relate to food intolerance and explores the impact of washed microbiota transplantation as a potential approach. The study is observational and focuses on understanding changes in symptoms and biological markers after treatment. The study compares two groups: patients with food intolerance who receive washed microbiota transplantation, where a prepared microbiota suspension is infused into their gut, and those who do not undergo this treatment. The transplantation aims to alter gut bacteria to assess its effects on food intolerance symptoms and related metabolic factors. Participants will be evaluated at the start and at 4 and 12 weeks after transplantation, with measurements including weight, height, and gastrointestinal symptoms. Researchers will also study changes in gut microbiota composition, insulin-like growth factor levels, intestinal barrier function, immune proteins, and any treatment-related adverse events. The study is expected to continue through 2035, allowing long-term monitoring of outcomes.
CONDITIONS
Brief Title
Washed Microbiota Transplantation for Food Intolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Food intolerance diagnosed through laboratory examination involving at least two main foods
- Underwent washed microbiota transplantation
You will not qualify if you...
- Expected survival time less than 3 months
- Women who are pregnant or breastfeeding
- Other patients deemed not suitable for enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants diagnosed with food intolerance undergo washed microbiota transplantation where a prepared microbiota suspension is infused into their gut.
Visits at baseline, 4 weeks, and 12 weeks post transplantation
Duration - 12 weeks post transplantation
Participants are observed to assess changes in weight, gastrointestinal symptoms, insulin-like growth factor I levels, intestinal barrier function, immunoglobulins, and gut microbiota composition, as well as to monitor for treatment-related adverse events.
Visits at baseline and 12 weeks post transplantation
Trial Site Locations
Total: 1 location
1
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
F
Faming Zhang, PhD
B
Bota Cui, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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