Washed Microbiota Transplantation for Food Intolerance

NCT ID: NCT07190183

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2035-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The FI undergoing washed microbiota transplantation

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

washed microbiota transplantation

Intervention Type: PROCEDURE

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

The FI not undergoing washed microbiota transplantation

The FI did not undergo washed microbiota transplantation

No interventions assigned to this group

Interventions

washed microbiota transplantation

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

Intervention Type: PROCEDURE

Other Intervention Names

fecal microbiota transplantation

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Professsor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Locations

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

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, PhD

Role: CONTACT

fzhang@njmu.edu.cn

086-025-58509883

Bota Cui, PhD

Role: CONTACT

cuibota@njmu.edu.cn

086-025-58509884

Facility Contacts

Faming Zhang, PhD

Role: primary

fzhang@njmu.edu.cn

086-025-58509883

Other Identifiers

WMT-FI

Identifier Type: -

Identifier Source: org_study_id