Skip to content

Evaluation of intervention effect of intestinal flora transplantation on severe food intolerance-related diseases

Evaluation of intervention effect of intestinal flora transplantation on severe food intolerance-related diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071288
Enrollment
Unknown
Registered
2023-05-10
Start date
2017-03-29
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irritable bowel syndrome (IBS)

Interventions

Experimental group:Oral administration of fecal bacteria capsules

Sponsors

Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Nationality: Chinese; 2. Aged 18-60 years; 3. Meet the Rome IV diagnostic criteria for each subtype of IBS.

Exclusion criteria

Exclusion criteria: 1. History of antibiotics and/or immunosuppressants and/or probiotics and/or laxatives (including diet drugs) within the last 3 months; 2. Patients with congenital or acquired immune deficiency or severe immunosuppression (neutrophils <1500 /mm^3, lymphocytes <500 /mm^3); 3. Severe damage of intestinal mucosa or failure to identify the cause of intestinal mucosal injury; 4. Currently diagnosed with fulminant colitis or toxic megacolon; 5. Enteral nutrition patients who cannot tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stricture, severe gastrointestinal bleeding, high-flow intestinal fistula, etc.; 6. Patients with parenteral organ infection requiring broad-spectrum antibiotic intervention; 7. Patients with severe malnutrition (body mass index <15kg/m^2) and severe hypoproteinemia (albumin <25g/L); 8. Patients with severe allergies; 9. Patients who are preparing for pregnancy or during pregnancy or breastfeeding; 10. Patients who are unable to take care of themselves or have serious psychological or mobility disorders and cannot actively cooperate with the completion of intervention.

Design outcomes

Primary

MeasureTime frame
IBS symptom severity scale, IBS-SSS;IBS quality of life, IBS-QoL;objective remission rate;16s RNA gut microbiota health assessment;physiological index detection;effectiveness evaluation;

Secondary

MeasureTime frame
adverse reaction;

Countries

China

Contacts

Public ContactZeng Qiang

The Second Medical Center and National Clinical Research Center for Geriatric Disease, Chinese People's Liberation Army General Hospital

zq301@126.com+86 139 1173 6252

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026