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NCT Number: NCT07190183

Washed Microbiota Transplantation for Food Intolerance

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Faming Zhang, PhD

CONTACT

[email protected]

086-025-58509883

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

washed microbiota transplantation

Procedure

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

Other names: fecal microbiota transplantation

Primary outcomes

  1. 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.

  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.

Secondary outcomes

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

    Time frame: baseline, 12 weeks post transplantation

    Blood test

  2. the difference of the gut microbiota composition before and after washed microbiota transplantation

    Time frame: baseline, 12 weeks post 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.

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

    Time frame: 12 weeks post transplantation

    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.).

Study contacts

Contact information is provided by the study sponsor or research team.

Bota Cui, PhD

CONTACT

[email protected]

086-025-58509884

Faming Zhang, PhD

CONTACT

[email protected]

086-025-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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