Washed Microbiota Transplantation for Food Intolerance

NCT07190183 | Recruiting DMC

• 1 other identifier: WMT-FI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Food Intolerance

Keywords

washed microbiota transplantation; food intolerance; fecal microbiota transplantation; gut microbiota

Outcome Measures

Primary Outcomes (2)

• change of weight and height

  Weight and height will be combined to report BMI in kg/m\^2.

  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.

  baseline, 4 weeks, 12 weeks post transplantation

Secondary Outcomes (3)

• change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin

  baseline, 12 weeks post transplantation

• the difference of the gut microbiota composition before and after washed microbiota transplantation

  baseline, 12 weeks post transplantation

• the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0

  12 weeks post transplantation

Study Arms (2)

The FI undergoing washed microbiota transplantation

patients undergoing washed microbiota transplantation who were diagnosed as food intolerance according to laboratory examination

Procedure: washed microbiota transplantation

The FI not undergoing washed microbiota transplantation

The FI did not undergo washed microbiota transplantation

Interventions

washed microbiota transplantation PROCEDURE

The prepared microbiota suspension was infused into the patients' gut.

Also known as: fecal microbiota transplantation

The FI undergoing washed microbiota transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with food intolerance receiving WMT will be enrolled.

You may qualify if:

• Food intolerance occurs through laboratory examination of at least two main foods
• Underwent washed microbiota transplantation.

You may not qualify if:

• Expected survival time \<3 months;
• Women who are pregnant or breastfeeding;
• Other patients deemed not suitable for enrollment by the investigator.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

faeces

MeSH Terms

Conditions

Food Intolerance

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-025-58509883; fzhang@njmu.edu.cn

Bota Cui, PhD

CONTACT

086-025-58509884; cuibota@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professsor, Gastroenterology

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): February 10, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: September 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)