Food IntoleranceNCT07190183
Washed Microbiota Transplantation for Food Intolerance
An observational study of Food Intolerance, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Intolerance
- What is being tested?
- washed microbiota transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2035
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with food intolerance receiving WMT will be enrolled.
Who may be able to join
- Food intolerance occurs through laboratory examination of at least two main foods
- Underwent washed microbiota transplantation.
Who cannot join
- Expected survival time <3 months;
- Women who are pregnant or breastfeeding;
- Other patients deemed not suitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Faming Zhang, PhD, 086-025-58509883, fzhang@njmu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Food Intolerance
- Being tested
- washed microbiota transplantation
- Keywords
- washed microbiota transplantation, food intolerance, fecal microbiota transplantation, gut microbiota
- Medical subject headings
- Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
washed microbiota transplantationProcedure or surgery
Also called fecal microbiota transplantation
The prepared microbiota suspension was infused into the patients' gut.
| Study group | Role | What they receive |
|---|---|---|
| The FI undergoing washed microbiota transplantation | patients undergoing washed microbiota transplantation who were diagnosed as food intolerance according to laboratory examination Receives: Procedure: washed microbiota transplantation | |
| The FI not undergoing washed microbiota transplantation | The FI did not undergo washed microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of weight and height
Weight and height will be combined to report BMI in kg/m^2.
Measured: baseline, 4 weeks, 12 weeks post transplantation
change of the Gastrointestinal Symptom Rating Scale(GSRS)
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.
Measured: baseline, 4 weeks, 12 weeks post transplantation
Secondary outcomes (3)
change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin
Blood test
Measured: baseline, 12 weeks post transplantation
the difference of the gut microbiota composition before and after washed microbiota 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.
Measured: baseline, 12 weeks post transplantation
the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
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.).
Measured: 12 weeks post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Jan 2025
- Primary completion10 Feb 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190183
- Sponsor's protocol ID
- WMT-FI
- Status last verified
- Jan 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washed Microbiota Transplantation for Food Intolerance
- ClinicalTrials.gov ID
- NCT07190183
- Acronym / sponsor ID
- WMT-FI
- Conditions
- Food Intolerance
- Keywords
- washed microbiota transplantation, food intolerance, fecal microbiota transplantation, gut microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 10 Feb 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The FI undergoing washed microbiota transplantation | – | Procedure: washed microbiota transplantationpatients undergoing washed microbiota transplantation who were diagnosed as food intolerance according to laboratory examination |
| The FI not undergoing washed microbiota transplantation | – | –The FI did not undergo washed microbiota transplantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with food intolerance receiving WMT will be enrolled.
Key inclusion criteria (2 listed)
- Food intolerance occurs through laboratory examination of at least two main foods
- Underwent washed microbiota transplantation.
Key exclusion criteria (3 listed)
- Expected survival time <3 months;
- Women who are pregnant or breastfeeding;
- Other patients deemed not suitable for enrollment by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| washed microbiota transplantationAlso: fecal microbiota transplantationThe prepared microbiota suspension was infused into the patients' gut. | Procedure or surgery | The FI undergoing washed microbiota transplantation |
Primary outcome
change of weight and height
Time frame: 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)
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faming Zhang, PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Intolerance, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of weight and height (time frame: baseline, 4 weeks, 12 weeks post transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025; AzTrials last refreshed its copy on 3 Nov 2026.