P0131 - Donor Screening for Fecal Microbiota Transplantation in China: Evaluation of 8,483 Candidates

Shaoyi Zhang, MD, PhD¹, Chen Ye, MD², Colleen R. Kelly, MD, FACG³, Zain Kassam, MD, MPH⁴, Di Zhao, ², Hongliang Tian, MD, PhD², Zhiliang Lin, MD, PhD², Xueying Zhang, MD, PhD², Bo Yang, MD², Qiyi Chen, MD, PhD², Huanlong Qin, MD, PhD², Ning Li, MD, PhD^2
1Stat, Shanghai, Shanghai, China; ²Shanghai Tenth People’s Hospital, Tenth People’s Hospital of Tongji University, Shanghai, Shanghai, China; ³Warren Alpert Medical School of Brown University and Lifespan Physician Group Gastroenterology, East Providence, RI; ⁴Finch Therapeutics, Somerville, MA

Introduction: A robust donor screening program is an important element of safe fecal microbiota transplantation (FMT); however, there are limited data with variable screening rates. Recently, a large FMT program in the United States reported data that suggest a qualification rate of approximately 2.5%; however, the qualification rate for donors in Asia has not been described. Accordingly, we outline the eligibility rate and etiology of exclusion for the largest FMT center in China.

Methods: The standardized donor screening program is based on the Chinese Expert Consensus FMT guideline. Enrollment of candidate donors was conducted prospectively in a 5-step protocol. In the first step, candidate donors are excluded based on age, body mass index, and high-risk sexual behaviors and personal history. In the second step, a more detailed clinical evaluation is conducted for microbiome-mediated diseases and risk factors for transmissible infection. This step also excludes candidates with a history of chronic diseases and mental health conditions as per assessment by both a trained physician and senior psychiatrist. In the third step, candidate donors undergo stool testing including 16S sequencing to evaluate dysbiosis (Shannon’s diversity index lower than 50% normal population excluded) and a full panel test of infectious pathogens, and in the fourth step they undergo hematologic and serologic testing to exclude blood-borne pathogens and systemic organ dysfunction. In the fifth step, donors are evaluated for diet restriction if material is for a recipient with significant food allergies, as well as logistical and quality control factors.

Results: Between April 2012 and December 2020, a total of 8,483 donor candidates were evaluated (Figure 1). Most common exclusion criteria at each step included: age (n=1,364) or non-optimal BMI (n=1,383) at step 1, history of chronic disease (n=461) at step 2, intestinal dysbiosis (n=280) at step 3, abnormal liver panel (n=104) at step 4 and unqualified amount of exercise (n=193) at step 5. Overall, 145 candidate donors qualified resulting in a 1.7% qualification rate (Figure 1).

Discussion: The donor screening qualification rate in China is in keeping with that from a large US stool bank. However, stricter criteria including narrower age and BMI range as well as assessment of intestinal dysbiosis by 16sRNA sequencing may contribute to the lower qualification rate reported.


Figure: Figure 1. Working flow of the FMT donors screening strategy


Disclosures:
Shaoyi Zhang indicated no relevant financial relationships.
Chen Ye indicated no relevant financial relationships.
Colleen Kelly indicated no relevant financial relationships.
Zain Kassam: Finch Therapeutics – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Di Zhao indicated no relevant financial relationships.
Hongliang Tian indicated no relevant financial relationships.
Zhiliang Lin indicated no relevant financial relationships.
Xueying Zhang indicated no relevant financial relationships.
Bo Yang indicated no relevant financial relationships.
Qiyi Chen indicated no relevant financial relationships.
Huanlong Qin indicated no relevant financial relationships.
Ning Li indicated no relevant financial relationships.


Shaoyi Zhang, MD, PhD¹, Chen Ye, MD², Colleen R. Kelly, MD, FACG³, Zain Kassam, MD, MPH⁴, Di Zhao, ², Hongliang Tian, MD, PhD², Zhiliang Lin, MD, PhD², Xueying Zhang, MD, PhD², Bo Yang, MD², Qiyi Chen, MD, PhD², Huanlong Qin, MD, PhD², Ning Li, MD, PhD². P0131 - Donor Screening for Fecal Microbiota Transplantation in China: Evaluation of 8,483 Candidates, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.