Validation of Lyophilized Human Fecal Microbiota for the Treatment of Clostridioides difficile Infection: A Pilot Study with Pharmacoeconomic Analysis of a Middle-Income Country—Promicrobioma Project
Abstract
:1. Introduction
2. Methods
2.1. Human Fecal Microbiota for Transplant
2.1.1. Donor Selection and Testing
2.1.2. Feces Processing
2.1.3. Non-Bacterial Fecal Residue Analysis
2.1.4. Bacterial Viability and Shelf-Life
Next-Generation Sequencing
2.2. Pilot Clinical Study
2.2.1. Study Design
2.2.2. Setting
2.2.3. Participants
2.2.4. Intervention
2.2.5. Variables
2.2.6. Data Sources and Study Size
2.3. Cost-Effectiveness Evaluation
2.3.1. Study Design
2.3.2. Setting
2.3.3. Data Source
2.3.4. Variables
2.4. Statistical Analysis
3. Results
3.1. Fecal Microbiota Validation for Transplant
3.2. Pilot Clinical Study
3.3. Cost–Benefit Evaluation
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Patient | Age | ICU * | Previous Therapy for CDI | Days of Therapy before FMT | Indication of FMT | Mean Daily Evacuations before FMT | Outcome | Clinical Response (Days) | Comorbidities |
---|---|---|---|---|---|---|---|---|---|
1 | 76 | No | Vancomycin | 42 | Recurrence | 6 | Cure | 2 | DM, HF, SAH |
2 | 79 | No | Vancomycin + metronidazole | 28 | Recurrence | 12 | Cure | 5 | DM, SAH |
3 | 74 | No | Vancomycin | 36 | Recurrence | 2 | Cure | 1 | Gastrointestinal neuroendocrinal tumor |
4 | 85 | No | Vancomycin | 28 | Refractory | 8 | Cure | 3 | Renal cancer |
5 | 65 | No | Vancomycin | 14 | Recurrence | 10 | Cure | 4 | Lung cancer |
6 | 65 | No | Vancomycin | 5 | Refractory | 10 | Cure | 2 | Lung cancer |
7 | 38 | No | Vancomycin | 14 | Recurrence | 4 | Cure | 7 | Colorectal cancer |
8 | 54 | No | Vancomycin | 9 | Refractory | 15 | Failure | - | Renal transplant |
9 | 54 | No | Vancomycin | 10 | Refractory | 20 | Cure | 3 | Renal transplant |
10 | 67 | No | Vancomycin | 9 | Refractory | 8 | Cure | 5 | Chron disease |
11 | 65 | No | Vancomycin | 15 | Refractory | 7 | Cure | 7 | - |
12 | 65 | No | Vancomycin | 14 | Recurrence | 12 | Cure | 2 | - |
13 | 72 | No | Metronidazole | 14 | Refractory | 5 | Cure | 1 | CRF, DM |
14 | 80 | Yes | Vancomycin | 8 | Refractory | 6 | Cure | 1 | DM, SAH |
15 | 84 | No | Vancomycin | 10 | Refractory | 4 | Cure | 2 | Dementia |
16 | 56 | No | Metronidazole | 13 | Refractory | 7 | Cure | 1 | CRF |
17 | 70 | Yes | Metronidazole | 14 | Recurrence | 8 | Cure | 2 | DM |
18 | 73 | Yes | Vancomycin + metronidazole | 28 | Refractory | 5 | Cure | 2 | DM, stroke |
19 | 53 | Yes | Vancomycin + metronidazole | 14 | Refractory | 3 | Cure | 3 | DM, SAH, multiple sclerosis |
20 | 65 | Yes | Vancomycin + metronidazole | 7 | Refractory | 12 | Cure | 1 | HIV |
21 | 69 | No | Vancomycin + metronidazole | 28 | Recurrence | 6 | Cure | 3 | Stroke, DM, SAH |
22 | 54 | Yes | Vancomycin + metronidazole | 21 | Refractory | 8 | Cure | 5 | - |
23 | 56 | Yes | Vancomycin + metronidazole | 14 | Refractory | 7 | Failure | - | - |
24 | 54 | No | Vancomycin | 28 | Recurrence | 5 | Cure | 7 | - |
Year | Monitored Population | Community Associated CDI | Community Cases % | Community Cases 1 | Health-Care-Associated CDI | Health-Care Cases % | Health-Care Cases 1 |
---|---|---|---|---|---|---|---|
2013 | 11,552,955 | 6441 | 39.32% | 55.75 | 9938 | 60.68% | 86.02 |
2014 | 11,533,856 | 6670 | 40.84% | 57.83 | 9663 | 59.16% | 83.79 |
2015 | 11,682,427 | 7688 | 44.30% | 65.81 | 9666 | 55.70% | 82.74 |
2016 | 11,777,482 | 7915 | 47.12% | 67.20 | 8881 | 52.88% | 75.41 |
2017 | 11,906,512 | 7539 | 48.60% | 63.32 | 7973 | 51.40% | 66.96 |
2018 | 11,982,926 | 7901 | 50.68% | 65.93 | 7690 | 49.32% | 64.18 |
2019 | 12,058,331 | 7628 | 52.20% | 63.30 | 6984 | 47.80% | 57.90 |
2020 | 12,104,962 | 6198 | 50.55% | 51.20 | 6062 | 49.45% | 50.10 |
2021 | 12,109,721 | 6769 | 50.71% | 55.90 | 6579 | 49.29% | 54.30 |
Demographic Characteristic | Population ≥ 1 Year of Age | Community-Associated CDI | Health Care-Associated CDI | ||||||
---|---|---|---|---|---|---|---|---|---|
Cases | ±σ | Cases 100,000 Persons | ±σ | Cases | ±σ | Cases 100,000 Persons | ±σ | ||
Sex | |||||||||
Female | 99,270,508 | 69,266 | 1930 | 69.77 | 1.94 | 94,457 | 2707 | 95.15 | 2.73 |
Male | 103,792,004 | 41,777 | 1981 | 40.25 | 1.91 | 69,316 | 1981 | 66.78 | 1.91 |
Age Group | |||||||||
1–17 years | 45,732,492 | 8411 | 238 | 18.39 | 0.52 | 3285 | 90 | 7.18 | 0.20 |
18–44 years | 87,378,489 | 27,246 | 774 | 31.18 | 0.89 | 17,271 | 492 | 19.77 | 0.56 |
45–64 years | 46,201,082 | 34,092 | 1010 | 73.79 | 2.19 | 41,668 | 1192 | 90.19 | 2.58 |
65+ years | 20,915,569 | 36,743 | 1101 | 175.67 | 5.27 | 105,241 | 3034 | 503.17 | 14.5 |
Treatment | Hypothesis (Days) | Fixed Cost Ward USD | Variable Cost Ward USD | Mild USD | Moderate USD | Severe USD |
---|---|---|---|---|---|---|
Metronidazole Pill 2 × 250 mg q8h | 10 | 157.81 | 79.39 | 1657.43 | - | - |
11 | 157.81 | 79.62 | 1815.47 | - | - | |
12 | 157.81 | 79.85 | 1973.50 | - | - | |
13 | 157.81 | 80.09 | 2131.54 | - | - | |
14 | 157.81 | 80.32 | 2289.58 | - | - | |
Vancomycin Ampoule 125 mg q6h | 10 | 157.81 | 121.54 | 1699.58 | 1699.58 | - |
11 | 157.81 | 125.68 | 1861.52 | 1861.52 | - | |
12 | 157.81 | 129.84 | 2023.49 | 2023.49 | - | |
13 | 157.81 | 134.02 | 2185.48 | 2185.48 | - | |
14 | 157.81 | 138.22 | 2347.48 | 2347.48 | - | |
Fecal microbiota transplant | 2 | 157.81 | 839.54 | - | - | 1155.15 |
3 | 157.81 | 839.54 | - | - | 1312.96 |
Treatment | Hypothesis (Days) | Fixed Cost ICU USD | Variable Cost ICU USD | Mild USD | Moderate USD | Serious USD |
---|---|---|---|---|---|---|
Metronidazole Pill 2 × 250 mg q8h | 10 | 382.33 | 79.39 | 3902.65 | - | - |
11 | 382.33 | 79.62 | 4285.21 | - | - | |
12 | 382.33 | 79.85 | 4667.77 | - | - | |
13 | 382.33 | 80.09 | 5050.33 | - | - | |
14 | 382.33 | 80.32 | 5432.89 | - | - | |
Vancomycin Ampoule 125 mg q6h | 10 | 382.33 | 121.54 | 3944.80 | 3944.80 | - |
11 | 382.33 | 125.68 | 4331.27 | 4331.27 | - | |
12 | 382.33 | 129.84 | 4717.76 | 4717.76 | - | |
13 | 382.33 | 134.02 | 5104.26 | 5104.26 | - | |
14 | 382.33 | 138.22 | 5490.79 | 5490.79 | - | |
Fecal Microbiota Transplant | 2 | 382.33 | 839.54 | - | - | 1604.20 |
3 | 382.33 | 839.54 | - | - | 1986.52 |
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Yamada, C.H.; Ortis, G.B.; Buso, G.M.; Martins, T.C.; Zequinao, T.; Telles, J.P.; Wollmann, L.C.; Montenegro, C.d.O.; Dantas, L.R.; Cruz, J.W.; et al. Validation of Lyophilized Human Fecal Microbiota for the Treatment of Clostridioides difficile Infection: A Pilot Study with Pharmacoeconomic Analysis of a Middle-Income Country—Promicrobioma Project. Microorganisms 2024, 12, 1741. https://doi.org/10.3390/microorganisms12081741
Yamada CH, Ortis GB, Buso GM, Martins TC, Zequinao T, Telles JP, Wollmann LC, Montenegro CdO, Dantas LR, Cruz JW, et al. Validation of Lyophilized Human Fecal Microbiota for the Treatment of Clostridioides difficile Infection: A Pilot Study with Pharmacoeconomic Analysis of a Middle-Income Country—Promicrobioma Project. Microorganisms. 2024; 12(8):1741. https://doi.org/10.3390/microorganisms12081741
Chicago/Turabian StyleYamada, Carolina Hikari, Gabriel Burato Ortis, Gustavo Martini Buso, Thalissa Colodiano Martins, Tiago Zequinao, Joao Paulo Telles, Luciana Cristina Wollmann, Carolina de Oliveira Montenegro, Leticia Ramos Dantas, June Westarb Cruz, and et al. 2024. "Validation of Lyophilized Human Fecal Microbiota for the Treatment of Clostridioides difficile Infection: A Pilot Study with Pharmacoeconomic Analysis of a Middle-Income Country—Promicrobioma Project" Microorganisms 12, no. 8: 1741. https://doi.org/10.3390/microorganisms12081741