Fecal Microbiota Transplantation (FMT) for Treatment of Clostridium difficile Infection (CDI) in Immunocompromised Patients: ACG Governors Award for Excellence in Clinical Research
Bibliographic record
Abstract
Purpose: Patients who are immunocompromised (IC) are at increased risk of CDI, which has increased to epidemic proportions over the past decade. FMT appears effective for the treatment of CDI, though there is concern that IC patients may be at increased risk of having adverse events (AE) related to FMT. In this multicenter study, we aimed to describe rates of CDI cure after FMT as well as AE experienced by IC patients after FMT. Methods: A multicenter retrospective series was performed of the use of FMT in IC patients with CDI that was recurrent, refractory, or severe. A 32-item questionnaire soliciting demographic and pre- and post-FMT data was completed at 16 centers for 83 patients, of which 66 were eligible based on at least 12 weeks of post-FMT follow up. Outcomes included: (1) rates of CDI cure after FMT, (2) serious adverse events (SAE) such as death or hospitalization within 12 weeks of FMT, (3) infection within 12 weeks of FMT, and (4) AE related and unrelated to FMT. Results: Cases included adult (61) and pediatric (5) patients treated with FMT for refractory (12%), recurrent (54%), and overlap of recurrent/refractory and severe CDI (34%). Seventy eight percent were outpatients at time of FMT. The mean follow-up period between FMT and data collection was 12 months (range: 3-51 months). Reasons for IC included: HIV/AIDS (2), solid organ transplant (14), oncologic conditions (6), immunosuppressive therapy for IBD (32), and other IC due to medical condition/medication (12). The CDI cure rate after a single FMT was 78%, with 52 patients experiencing no recurrence at least 12 weeks post-FMT. Nine patients underwent repeat FMT, of which seven had no further CDI. Thus, the overall cure rate was 89%. Ten (15%) patients had a SAE within 12 weeks post-FMT, of which eight were hospitalizations. Two deaths occurred within 12 weeks of FMT, one of which was the result of aspiration during sedation for FMT administered via colonoscopy; the other was unrelated to FMT. None suffered infections definitely related to FMT, but one patient developed unrelated infection and two had self-limited diarrheal illness, which were probably unrelated, and for which no causal organism was identified. Three IBD patients (9%) experienced disease flare post-FMT. Two ulcerative colitis (UC) patients underwent colectomy related to course of UC >100 days after FMT. One patient had a superficial mucosal tear caused by the FMT colonoscopy and four patients reported mild, self limited abdominal discomfort post-FMT. Conclusion: This series demonstrates effective use of FMT for CDI in IC patients with few SAE or related AE. Importantly, there were no infectious complications in these high-risk patients. Further prospective studies of FMT in IC patients are needed to confirm safety and efficacy in this population. Disclosure - Dr. Khoruts-Research Support: CIPAC, Ltd Dr. Brandt-Speaker's Bureau/Research Support: Optimer Pharmaceuticals, Inc. Dr. Gordon-Speaker: Cubist.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".