Prospective Laboratory Evaluation of Fecal Microbiota Transplantation Donors: Results From an International Public Stool Bank

Ling, Kelly; Koelsch, Emily; Dubois, Nancy; OʼBrien, Kelsey; Stoltzner, Zachery; Panchal, Pratik; Amaratunga, Kanchana; Kassam, Zain; Osman, Majdi

doi:10.1093/ofid/ofw172.1671

Cited by 3 publications

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“…Two donor fecal microbiota preparations (FMP) were provided from rigorously screened healthy donors from a universal stool bank (OpenBiome) (6). 60 ml of material from each of two donors was thawed, pooled, and homogenized immediately prior to colonoscopic delivery to the ileum and right colon.…”

Section: Methodsmentioning

confidence: 99%

Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis

Jacob

Crawford

Cohen‐Mekelburg

et al. 2017

Inflammatory Bowel Diseases

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Background: Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high diversity FMT donors is a promising treatment to induce remission in ulcerative colitis (UC). Methods: We designed a prospective, open-label pilot study to assess the safety, clinical efficacy, and microbial engraftment of single FMT delivery by colonoscopy for active UC using a two donor fecal microbiota preparation (FMP). Safety and clinical endpoints of response, remission, and mucosal healing at week 4 were assessed. Fecal DNA and rectal biopsies were used to characterize the microbiome and mucosal CD4+ T cells, respectively, before and after FMT. Results: Seven patients (35%) achieved a clinical response by week 4. Three patients (15%) were in remission at week 4 and two of these patients (10%) achieved mucosal healing. Three patients (15%) required escalation of care. No serious adverse events were observed. Microbiome analysis revealed that restricted diversity of recipients pre-FMT was significantly increased by high diversity two donor FMP. The microbiome of recipients post-transplant was more similar to the donor FMP than the pre-transplant recipient sample in both responders and non-responders. Notably, donor composition correlated with clinical response. Mucosal CD4+ T cell analysis revealed a reduction in both Th1 and regulatory T cells post-FMT. Conclusions: High-diversity, two donor FMP delivery by colonoscopy is safe and effective in increasing fecal microbial diversity in patients with active UC. Donor composition correlated with clinical response and further characterization of immunological parameters may provide insight into factors influencing clinical outcome.

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Section: Methodsmentioning

confidence: 99%

Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis

Jacob

Crawford

Cohen‐Mekelburg

et al. 2017

Inflammatory Bowel Diseases

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“…Donors aged between 18 to 50 without smoking, alcohol, or other bad habits or digestive symptoms were provided from rigorously screened healthy donors from a universal stool bank (OpenBiome)[12]. Eligible donors underwent serological testing for HIV type 1 and 2 antibody (Ab), hepatitis A total Ab, hepatitis B surface antigen (Ag), hepatitis B surface Ab, hepatitis B core Ab (IgM and IgG), hepatitis C Ab, syphilis Ab, CMV IgM, EBV-DNA, human parvovirus B19 IgM, TORCH, T-SPOT, hepatic and renal function, routine blood parameters, and lymphatic subgroup analysis.…”

Section: Methodsmentioning

confidence: 99%

Safety of fecal microbiota transplantation in chinese children: A single-center retrospective study

Zhang¹,

Wang²,

Li³

et al. 2018

WJCC

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BACKGROUNDFecal microbiota transplantation (FMT) is the administration of fecal bacterial liquid from healthy donors to a recipient’s digestive tract, which is recommended as a therapeutic method for recurrent Clostridium difficile infection (CDI). Many clinical trials focusing on different diseases are in progress. To date, scarce research and long-term follow-up have been conducted on FMT in children or on the proper guidelines. Our center first performed FMT to treat a 13-month-old boy with severe CDI in 2013. Until February 2018, our center had performed 114 pediatric FMT procedures in 49 subjects.AIMTo investigate the safety of FMT in children.METHODSA retrospective study was conducted on 49 patients who underwent 114 FMT treatments at our hospital. All FMT processes followed uniform standards. Adverse events (AEs) related to FMT were divided into short-term (48 h post-FMT) and long-term (3 mo). All potential influencing factors for AEs, such as gender, age, time of FMT infusion, route of administration, disease type, immune function state, and donor relative genetic background, were analyzed as independent factors. The significant independent factors and risk ratio with 95% confidence interval (CI) were assessed by multivariate logistic regression analysis.RESULTSForty-nine patients (mean age 68.1 mo, range 4 to 193 mo) were recruited. Their average follow-up time after the first FMT was 23.1 mo. The incidence of short-term AEs was 26.32% (30/114). The most common short-term AEs were abdominal pain, diarrhea, fever, and vomiting, which were all self-limited and symptom-free within 48 h. Two severe AEs occurred, and one patient died in the fourth week after FMT. All-cause mortality was 2.04%. As independent factors, age (P = 0.006) and immune state (P = 0.002) had significant effects. Age greater than 72 mo seemed to be correlated with more AEs than age 13 to 36 mo (P = 0.04). In multivariate logistic regression analysis, immune state was an independent risk factor for AE occurrence (P = 0.035), and the risk ratio in immunodeficient patients was 3.105 (95%CI: 1.080-8.923).CONCLUSIONAlthough FMT was proven to be tolerated in children, we need to be more cautious with immunodeficient patients. The effect on children’s long-term health is unpredictable.

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“…Five donor samples were ordered from OpenBiome™ (Medford, MA) to be used for the FMT procedure. All donors were non-family related and underwent laboratory screening by Openbiome™ (Ling K et al 2016;Osman et al 2016 Manuscript to be reviewed follow-up visit, attempts to collect a response were performed for up to 15 months after the procedure. (Although fecal samples were collected outside of the 3-month study period, patients were not clinically re-evaluated for evidence of rCDI beyond 3 months of the date of fecal microbiota transplantation.…”

Section: Methodsmentioning

confidence: 99%

Peer Review #2 of "Applying fecal microbiota transplantation (FMT) to treat recurrent Clostridium difficile infections (rCDI) in children (v0.2)"

Solanki¹

2018

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Background: Fecal Microbiota Transplantation (FMT) is an innovative means of treating recurrent Clostridium difficile infection (rCDI), through restoration of gut floral balance. However, there is a lack of data concerning the efficacy of FMT and its impact on the gut microbiome among pediatric patients. This study analyzes clinical outcomes and microbial community composition among 15 pediatric patients treated for rCDI via FMT. Methods: This is a prospective, observational, pilot study of 15 children ≤ 18 years, who presented for rCDI and who met inclusion criteria for FMT at a pediatric hospital and pediatric gastroenterology clinic. Past medical history and demographics were recorded at enrollment and subsequent follow-up. Specimens of the donor and the patients' pre-FMT and post-FMT fecal specimen were collected and used to assess microbiome composition via 16S rRNA gene sequencing. Results: FMT successfully prevented rCDI episodes for minimum of 3 months post-FMT in all patients, with no major adverse effects. Three patients reported continued GI bleeding; however, all three also had underlying Inflammatory Bowel Disease (IBD). Our analyses confirm a significant difference between preand post-FMT gut microbiome profiles (Shannon diversity index), whereas no significant difference was observed between post-FMT and donor microbiome profiles. At the phyla level, post-FMT profiles showed significantly increased levels of Bacteroidetes and significantly decreased levels of Proteobacteria. Subjects with underlying IBD showed no difference in their pre-and post-FMT profiles. Conclusion: The low rate of recurrence or re-infection by C. difficile, coupled with minimal adverse effects post-FMT, suggests that FMT is a viable therapeutic means to treat pediatric rCDI. Post-FMT microbiomes are different from pre-FMT microbiomes, and similar to those of healthy donors, suggesting successful establishment of a healthier microbiome.

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Prospective Laboratory Evaluation of Fecal Microbiota Transplantation Donors: Results From an International Public Stool Bank

Cited by 3 publications

References 0 publications

Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis

Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis

Safety of fecal microbiota transplantation in chinese children: A single-center retrospective study

Peer Review #2 of "Applying fecal microbiota transplantation (FMT) to treat recurrent Clostridium difficile infections (rCDI) in children (v0.2)"

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