Washed microbiota transplantation to treat food intolerance
Washed Microbiota Transplantation for Food Intolerance
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07190183 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.