NCT05439135 Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract
| NCT ID | NCT05439135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Condition | Malnutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2024-10-20 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2024-10-20 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, randomized, multicenter study to evaluate WMT in improving nutritional status in malnourished patients who underwent nonphysiological reconstruction of the upper gastrointestinal tract. In this multicenter trial, sixty-two patients will be enrolled in forteen Chinese sites. Participants will be randomized at a ratio of 1:1 to receive three WMTs through either mid-gut tube or colonic TET. After WMT, each participant will receive free diet plus home enteral nutrition. Home enteral nutrition should last for 2 months at home, with blood, urine and stool samples taken and stored at baseline and 2 months after WMT.
Eligibility Criteria
Inclusion Criteria: * Patients undergone nonphysiological reconstruction of the gastrointestinal tract (such as Billroth-II, Roux-en-Y, Child, Whipple reconstruction) * Aged over 18 years old; * Malnutrition is assessed by Nutritional Risk Screening 2002 score≥3 and Patient Generated Subjective Global Assessment (PG-SGA) score≥4; * Written informed consent; Exclusion Criteria: * Expected survival time \< 3 months; * Still on anti-tumor therapy or it is expected during the visit; * Complicated with ascites or edema caused by malnutrition; * Known organic gastrointestinal disease (e.g., gastrointestinal infection, inflammatory bowel disease, or radiation enteritis); * Undergone other gastrointestinal surgery (e.g., enterectomy, enterostomy, or gastrostomy) except appendectomy or anal fistula surgery; * Complicated with contraindications of enteral nutrition such as ileus, active gastrointestinal bleeding, and shock; * Cannot tolerate gastroscopy or colonoscopy; * Severe comorbidities (e.g., diabetes, cardiopulmonary failure, severe liver or or kidney diseases); * Complicated with other wasting diseases (e.g., active tuberculosis, hyperthyroidism, diabetes, HIV, active hepatitis, hip fracture, craniocerebral injury, etc.); * A history of anti-infective treatment within 30 days before enrollment; or need anti-infective treatment at the time of enrollment; or unwilling to stop taking drugs that affect gut microbes, such as probiotics; * Can not tolerate oral enteral nutrition; * Women who are pregnant or breastfeeding; * Participating in another clinical trial; * Deemed unsuitable for inclusion by the investigators.
Frequently Asked Questions
Who can join the NCT05439135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malnutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05439135 currently recruiting?
Yes, NCT05439135 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Second Hospital of Nanjing Medical University to inquire about joining.
Where is the NCT05439135 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05439135 clinical trial?
NCT05439135 is sponsored by The Second Hospital of Nanjing Medical University. The trial plans to enroll 62 participants.