Washed microbiota transplantation to treat food intolerance
Official title: Washed Microbiota Transplantation for Food Intolerance
Run by The Second Hospital of Nanjing Medical University · NCT07190183 · Data updated 2026-11-12
This project tries washed microbiota transplantation to see if changing gut bacteria eases symptoms in people with laboratory-confirmed food intolerance.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | February 10, 2035 |
| Study ends | December 31, 2035 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT07190183 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients with laboratory-confirmed food intolerance to at least two main foods who undergo or have undergone washed microbiota transplantation at the study center.
✕Probably not a fit
People whose reactions are immune-mediated food allergies, caused solely by irreversible enzyme deficiencies, or who are pregnant, breastfeeding, or have a very limited life expectancy are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows patients with laboratory-confirmed food intolerance who have undergone washed microbiota transplantation (WMT) at a single tertiary center. Investigators will record clinical symptoms, laboratory findings, and microbiota composition before and after WMT to describe patterns of change. The design links patient histories, sequencing data, and symptom reports to explore associations between microbial shifts and improvements in food tolerance. There is no randomized control arm, and enrollment requires documented intolerance to at least two main foods and receipt of WMT at the study site.
Why it matters
Potential benefit: If successful, WMT could reduce food intolerance symptoms by restoring a healthier gut microbial balance and improving tolerance to trigger foods.
How similar studies have gone: Fecal microbiota transplantation has proven effective for Clostridioides difficile infection and shows promise in some metabolic and gastrointestinal conditions, but WMT specifically for food intolerance remains largely untested in rigorous trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Faming Zhang, PhD — The Second Hospital of Nanjing Medical University
- Study coordinator: Faming Zhang, PhD
- Email: fzhang@njmu.edu.cn
- Phone: 086-025-58509883
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Registry for individuals with food allergies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.