Skip to content

Evaluating the Efficacy of Precision-Matched Microbiota Transplantation in Treating Intestinal Diseases.

Evaluating the Efficacy of Precision-Matched Microbiota Transplantation in Treating Intestinal Diseases.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109998
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-10
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Inflammatory Bowel Disease(IBD),Chronic Gastritis,Chronic Constipation

Interventions

Control Group (Conventional FMT):For the control group, FMT was performed using the conventional donor selection protocol, which involved choosing either a qualified related donor or a randomly
Experimental Group (FMT following C2R model matching):FMT was performed using fecal capsules from the donor with the highest Bray-Curtis distance who had available capsule inventory in the donor gut m

Sponsors

The First People's Hospital of Nanning,Nanning Science and Technology Bureau
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Donor Inclusion Criteria 1. Age & Consent: > 18 years, Body Mass Index (BMI) 18.5-25 kg/m², voluntary participation. 2. Family History:Absence of genetic disorders, family history of malignancies, or psychiatric illnesses. 3. Personal Medical History:No gastrointestinal conditions (e.g., IBD, IBS, chronic diarrhea/constipation, celiac disease, bowel resection, bariatric surgery) or acute gastrointestinal symptoms within the past two weeks. No significant family history of gastrointestinal diseases (e.g., IBD, colorectal cancer). No history of ataxia, systemic autoimmune diseases, metabolic diseases, neurological/psychiatric disorders, prion disease risk, chronic pain syndromes, or malignancies. 4. Medication History: No use of specific medications within the past 3 months (e.g., antibiotics, proton pump inhibitors, immunosuppressants, chemotherapeutic agents, biologics). 5. Vaccination & Experimental Drug History:No administration of live-attenuated vaccines or receipt of any experimental drugs/vaccines within the past 6 months. 6. Travel History:No travel to tropical countries or areas with known clusters of infectious diseases within the past 6 months. 7. High-Risk Behaviors:No risk factors for blood-borne viruses within the past 6 months (e.g., high-risk sexual behavior, illicit drug use, tattoos, piercings, needle-stick injuries, blood transfusions, acupuncture). Recipient Inclusion Criteria 1. Meets the diagnostic criteria for the specific disease subgroup. 2. Voluntary acceptance of Fecal Microbiota Transplantation (FMT) treatment. 3. Age > 18 years. 4. Body Mass Index (BMI) 18.5-25 kg/m². 5. Normal hepatic, renal, cardiopulmonary function; no psychiatric disorders. 6. No history of gastrointestinal surgery. 7. No life-threatening illnesses or history of malignancies.

Exclusion criteria

Exclusion criteria: Donor Group Exclusion Criteria: Donors will be excluded from the study if they choose to withdraw at any stage of the project. Fecal samples that have not yet been used for Fecal Microbiota Transplantation (FMT) will be disposed of as medical waste. Samples that have already been transplanted cannot be retrieved. However, if the FMT procedure and subsequent follow-up for a donor have been completed, generating a complete dataset, the relevant data will continue to be included in the analysis. Recipient Group Exclusion Criteria: Recipients will be excluded from the study based on the following criteria: 1. Voluntary or involuntary withdrawal from the study at any stage. Similar to donors, if a recipient has completed the FMT procedure and follow-up, generating a complete dataset, their data will be retained for analysis. 2. Severe congenital anatomical abnormalities. 3. Secondary constipation attributable to factors such as medications, endocrine, metabolic, neurological, or psychiatric disorders. 4. Pregnancy or lactation in female participants. 5. Evidence of active intestinal pathogenic infection. 6. Use of antibiotics or proton pump inhibitors (PPIs) within the past 3 months. 7. Consumption of probiotics, prebiotics, or synbiotics within the past month. 8. Smoking or excessive alcohol consumption within the past month. 9. Co-existing conditions affecting intestinal motility, or use of medications known to influence motility (e.g., antidepressants, opioid analgesics, anticholinergics, calcium channel blockers, nitrates, antispasmodics).

Design outcomes

Primary

MeasureTime frame
Bray-Curtis distance;Colonizers to Residents;Primary disease remission status;

Secondary

MeasureTime frame
Gut microbiota composition;

Countries

China

Contacts

Public ContactHuali Huang

The First People's Hospital of Nanning

3304529608@qq.com+86 182 7719 1725

Outcome results

None listed

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