Exclusive Enteral Nutrition Plus Immediate vs. Delayed Washed Microbiota Transplantation in Crohn's Disease With Malnutrition: A Randomized Pilot Study

Liyuan Xiang, Yan Yu, Xiao Ding, Hui Zhang, Quan Wen, Bota Cui, Faming Zhang, Liyuan Xiang, Yan Yu, Xiao Ding, Hui Zhang, Quan Wen, Bota Cui, Faming Zhang

Abstract

Background: The potential of washed microbiota transplantation (WMT) in Crohn's disease (CD) has been reported. This study aimed to explore the suitable timing of WMT in patients with CD complicated with malnutrition. Methods: This is a randomized, open-label study. Patients with active CD complicated with malnutrition were included and 1:1 randomized to undergo WMT at day 1 (group WMT-DAY1) or day 8 (group WMT-DAY8). The observation duration was 15 days. Exclusive enteral nutrition (EEN) was administered in both groups. The primary outcome was the improvement in nutritional parameters at day 8 and day 15 in two groups. The secondary outcome was the rate of clinical remission at day 15 in two groups. Results: Totally 19 patients completed the trial. At day 8, the lymphocyte count, albumin and prealbumin increased significantly compared to those at day 1 in group WMT-DAY1 (p = 0.018, p = 0.028, p = 0.028, respectively), while no significant increase in any nutritional parameter was shown in group WMT-DAY8. At day 15, albumin increased significantly compared to that at day 1 in both groups (p < 0.05), while significant increase in prealbumin was only shown in group WMT-DAY1 (p = 0.004) compared to that at day 1. The rate of clinical remission at day 15 in group WMT-DAY1 and group WMT-DAY8 was 87.5% (7/8) and 72.7% (8/11), respectively (p = 0.603). Conclusion: EEN combined with immediate WMT intervention could rapidly improve the nutritional status and induce clinical remission in malnourished patients with CD. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02897661.

Keywords: Crohn's disease; exclusive enteral nutrition; fecal microbiota transplant; malnutrition; safety; washed microbiota transplantation.

Conflict of interest statement

FZ conceived the concept of GenFMTer and transendoscopic enteral tubing and devices related to them. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Xiang, Yu, Ding, Zhang, Wen, Cui and Zhang.

Figures

Figure 1
Figure 1
Flow of patients in the trial. WMT, washed microbiota transplantation.
Figure 2
Figure 2
Changes in nutritional parameters between day 1 and day 8, day 1 and day 15 in two groups. (A–D) Changes in hemoglobin, lymphocyte count, albumin, and prealbumin between day 1 and day 8 in group WMT-DAY1 and group WMT-DAY8, respectively. (E–H) Changes in hemoglobin, lymphocyte count, albumin, and prealbumin between day 1 and day 15 in group WMT-DAY1 and group WMT-DAY8, respectively. The distribution of values within each group at each timing is illustrated by mean and SD. In group WMT-DAY1, data of two patients at day 8 and another two patients at day 15 were unavailable. WMT, washed microbiota transplantation.

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