{
  "abstract": "Background Malnutrition is a common complication in patients after nonphysiological reconstruction of the upper digestive tract. Nutrition intervention is essential for those who are malnourished. However, a few malnourished patients are refractory to nutrition support because nonphysiological reconstruction influences bile acid metabolism and alters gut microbiome. Washed microbiota transplantation (WMT), a new stage of fecal microbiota transplantation (FMT), could contribute to the response to nutritional treatment ( IDDF2026-ABS-0281 Figure 1. The process of washed microbiota transplantation). The procedure of nonphysiological reconstruction alters the anatomy and physiology of the upper digestive tract, which might impact the efficacy and safety of WMT when choosing the mid-gut delivery way. This study aims to understand the role of colon microbiome-based care model, and explore the safe and effective delivery of microbiota for patients with ­malnutrition after nonphysiological reconstruction of the upper digestive tract.Methods This is an open-label, multicenter randomized controlled trial (RCT) ( IDDF2026-ABS-0281 Figure 2. Study design). Oral enteral nutrition (EN) will be administered at enrolment. Sixty-two participants who tolerate oral EN will be randomized at a ratio of 1:1 to receive three WMTs through either mid-gut tube or colonic transendoscopic enteral tube (TET) (IDDF2026-ABS-0281 Figure 3. Delivery of washed microbiota transplantation via mid-gut tube (A) or colonic transendoscopic enteral tube (B)). Then the patients will receive regular meals coupled with home enteral nutrition (HEN) for 8 weeks in both groups. The primary outcome measures are: (1) body mass index (BMI) calculated from weight and height [weight (kg)/height (m2); and (2) skeletal muscle index (SMI) calculated from the L3-skeletal muscle area (SMA) and height [SMA (cm2)/height (m2). The secondary outcome measures are a scale for the assessment of nutritional status, nutrition-based laboratory indices, 60-day readmission rate, quality of life and analysis of the biological specimens including blood, urine and stool (IDDF2026-ABS-0281 Figure 4. SPIRIT figure).Results This study remains a protocol, and its clinical trial has been registered on ClinicalTrials.gov, Registration Number: NCT05439135.Conclusions This is one of the first randomized studies on the use of WMT in the treatment of malnourished patients after nonphysiological reconstruction of the upper digestive tract. The results of this study are expected to pave the way for the application of WMT in malnourished patients and have the potential to identify the optimal delivery of WMT for patients after nonphysiological reconstruction of the upper digestive tract.Abstract IDDF2026-ABS-0281 Figure 1Abstract IDDF2026-ABS-0281 Figure 2Abstract IDDF2026-ABS-0281 Figure 3Abstract IDDF2026-ABS-0281 Figure 4",
  "authors": [
    {
      "affiliations": [
        "Department of Microbiota Medicine, The Second Affiliated Hospital of Nanjing Medical University, China"
      ],
      "name": "Mengxi Ma"
    },
    {
      "affiliations": [
        "Department of Microbiota Medicine, The Second Affiliated Hospital of Nanjing Medical University, China"
      ],
      "name": "Yun Wang"
    },
    {
      "affiliations": [
        "Department of Microbiota Medicine, The Second Affiliated Hospital of Nanjing Medical University, China"
      ],
      "name": "Xinyi He"
    },
    {
      "affiliations": [
        "Department of Microbiota Medicine, The Second Affiliated Hospital of Nanjing Medical University, China"
      ],
      "name": "Yuyan Xiao"
    },
    {
      "affiliations": [
        "Department of Microbiota Medicine, The Second Affiliated Hospital of Nanjing Medical University, China"
      ],
      "name": "Yilu Duan"
    },
    {
      "affiliations": [
        "Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China"
      ],
      "name": "Jianling Bai"
    },
    {
      "affiliations": [
        "Department of Microbiota Medicine, The Second Affiliated Hospital of Nanjing Medical University, China"
      ],
      "name": "Bota Cui"
    },
    {
      "affiliations": [
        "Department of Microbiota Medicine, The Second Affiliated Hospital of Nanjing Medical University, China"
      ],
      "name": "Faming Zhang"
    }
  ],
  "title": "IDDF2026-ABS-0281 Efficacy and safety of integrative microbiome-nutrition care with washed microbiota transplantation for malnutrition after upper digestive tract reconstruction: study protocol for a randomized controlled trial",
  "uid": "979b8a80-47e6-5670-afa7-15c404b0a97a"
}