Washed Microbiota Transplantation for Food Intolerance
ConditionFood Intolerance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Food intolerance occurs through laboratory examination of at least two main foods
Underwent washed microbiota transplantation.
Disqualifiers
Expected survival time <3 months;
Women who are pregnant or breastfeeding;
Other patients deemed not suitable for enrollment by the investigator.
Trial population
Patients with food intolerance receiving WMT will be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
washed microbiota transplantation
Procedure/SurgeryThe prepared microbiota suspension was infused into the patients' gut.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: The FI undergoing washed microbiota transplantation1 intervention
Group B: The FI not undergoing washed microbiota transplantation0 interventions
Trial outcomes
Primary outcomes
1
change of weight and height
Weight and height will be combined to report BMI in kg/m\^2.
Time frame
baseline, 4 weeks, 12 weeks post transplantation2
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.
Time frame
baseline, 4 weeks, 12 weeks post transplantationSecondary outcomes
1
change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin
Blood test
Time frame
baseline, 12 weeks post transplantation2
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.
Time frame
baseline, 12 weeks post transplantation3
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.).
Time frame
12 weeks post transplantationSponsors and contacts
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Source ClinicalTrials.gov