Clostridium Difficile Clinical Trial
Official title:
Observational Study in Patients Receiving a Digestive Microbiota Transplant According to a Standardized Protocol
The digestive microbiota graft is performed in three clinical circumstances:
Clostridium difficile colitis is responsible for numerous deaths each year showing a severe
prognosis. In 2013, fecal microbiote (or digestive microbiota) transplantation showed its
superiority compared to the reference treatment in recurrences of C. difficile colitis. Our
team has demonstrated the value of early grafting in C. difficile-associated colitis
associated with ribotype 027. This strain is associated with severe cases and high mortality.
In view of the major benefit observed in these particular clinical situations, investigators
have implemented since 2013 in C. difficile O27 colitis and then in 2014 in severe C.
difficile colitis and since May 2016 for all patients. More than 100 transplants were
performed in the department dividing the risk of mortality by 5. The investigators also
demonstrated the value of early fecal grafting in severe colitis irrespective of the ribotype
involved. In addition, The investigators want to evaluate our protocol of fecal microbiote
transplant from the first episode of C. difficile colitis in the "Unit of contagion at IHU".
2- Antibiotic-resistant bacteria In the case of digestive colonization with emergent
multi-resistant bacteria, the fecal transplant has proved its effectiveness..
3- Chronic diarrhea without etiologies Finally, and after the other etiologies have been
eliminated, the fecal graft may be used in this indication.
The purpose of this study is to study the characteristics of patients who have undergone
treatment by grafting of digestive microbiota according to a protocol standardized either by
nasogastric tube or by freeze-dried digestive microbiota capsules in 3 indications:
clostridium difficile Diarrhea, multidrug resistance bacteria and chronic unexplained
diarrhea without altering patient management elsewhere.
200 patients (adults) hospitalized for an episode of C. difficile colitis, multidrug
resistant bacteria or chronic diarrhea without etiologies will be recruited during a period
of 3 Years.
After treatment by grafting of digestive microbiota, and after signed consent, data were
collected during their hospitalization and followed up at one month, 3 months, 6 month and 2
years. Data were analysed in order to determine the characteristics of patients benefiting
from a digestive microbiota transplant according to a standardized protocol.
The digestive microbiota graft is performed in three clinical circumstances:
1. Clostridium difficile colitis is responsible for 15,000 deaths each year in the USA. The
prognosis is very severe in patients > 65 years old. In France, there were 1,800 deaths
related to this infection in 2014. In 2013, fecal microbiote (or digestive microbiota)
transplantation showed its superiority compared to the reference treatment in
recurrences of C. difficile colitis in a randomized trial. Our team has demonstrated the
value of early grafting in C. difficile-associated colitis associated with ribotype 027.
This strain is associated with severe cases and high mortality. In view of the major
benefit observed in these particular clinical situations, investigators have implemented
since 2013 in C. difficile O27 colitis and then in 2014 in severe C. difficile colitis
and since May 2016 for all patients. More than 100 transplants were performed in the
department dividing the risk of mortality by 5. The investigators also demonstrated the
value of early fecal grafting in severe colitis irrespective of the ribotype involved.
In addition, the investigators want to evaluate our protocol of fecal microbiote
transplant from the first episode of C. difficile colitis in the "Unit of contagion at
the Timone IHU".
2. Antibiotic-resistant bacteria In the case of digestive colonization with emergent
multi-resistant bacteria, the fecal transplant has proved its effectiveness both in the
literature and in our unit.
3. Chronic diarrhea without etiologies Finally, and after the other etiologies have been
eliminated, the fecal graft may be used in this indication.
The purpose of this study is to study the characteristics of patients who have undergone
treatment by grafting of digestive microbiota according to a protocol standardized either by
nasogastric tube or by freeze-dried digestive microbiota capsules in 3 indications:
clostridium difficile Diarrhea, multidrug resistance bacteria and chronic unexplained
diarrhea without altering patient management elsewhere.
200 patients (adults) hospitalized for an episode of C. difficile colitis, multidrug
resistant bacteria or chronic diarrhea without etiologies will be recruited during a period
of 3 Years.
After treatment by grafting of digestive microbiota, and after signed consent, data were
collected during their hospitalization and followed up at one month, 3 months, 6 month and 2
years. Data were analysed in order to determine the characteristics of patients benefiting
from a digestive microbiota transplant according to a standardized protocol.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02896244 -
AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
|
||
Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
Recruiting |
NCT01973465 -
Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis
|
N/A | |
Terminated |
NCT01048567 -
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
|
Phase 2 | |
Completed |
NCT01066221 -
Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile
|
N/A | |
Not yet recruiting |
NCT03586206 -
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
|
||
Completed |
NCT02563106 -
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
|
Phase 2 | |
Completed |
NCT02207140 -
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
|
Phase 0 | |
Completed |
NCT02857582 -
Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
|
Phase 2 | |
Not yet recruiting |
NCT01942447 -
Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
|
N/A | |
Active, not recruiting |
NCT01703494 -
Fecal Transplant for Relapsing C. Difficile Infection
|
Phase 2 | |
Completed |
NCT01813500 -
Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
|
N/A | |
Completed |
NCT01087892 -
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
|
N/A | |
Suspended |
NCT00591357 -
Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy
|
Phase 4 | |
Recruiting |
NCT00377078 -
Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.
|
N/A | |
Completed |
NCT02254967 -
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population
|
Phase 4 | |
Terminated |
NCT01775397 -
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
|
Phase 4 | |
Terminated |
NCT03617172 -
PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol
|
Phase 2 | |
Recruiting |
NCT05622721 -
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
|
||
Completed |
NCT02437487 -
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
|
Phase 2 |