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Digestive Microbiota Transplant

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ClinicalTrials.gov Identifier: NCT03606031
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date June 27, 2018
First Posted Date July 30, 2018
Last Update Posted Date July 30, 2018
Actual Study Start Date March 23, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2018)
  • graft indications [ Time Frame: 1 days ]
    • Clostridium difficile diarrhea
    • Carriage of antibiotic-resistant bacteria
    • Unexplained chronic diarrhea
  • recidive events [ Time Frame: 6 months ]
    evolutive data will be collected in the 6 month period of follow-up Data will be collected during clinical consultations: re-hospitalization new infectection death
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 27, 2018)
Duration of hospitalization [ Time Frame: up to 3 months ]
beginning and end of hospitalization
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Digestive Microbiota Transplant
Official Title Observational Study in Patients Receiving a Digestive Microbiota Transplant According to a Standardized Protocol
Brief Summary

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.

Detailed Description

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patient hospitalized for an episode of C. difficile colitis or multidrug resistant bacteria or chronic diarrhea without etiologies
Condition
  • Clostridium Difficile
  • Antibiotic Resistant Infection
  • Chronic Diarrhea of Unknown Origin
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 27, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient hospitalized for an episode of C. difficile colitis
  • Patient hospitalized multidrug resistant bacteria
  • Patient hospitalized for chronic diarrhea without etiologies
  • Patient is more than 18 years old.

Exclusion Criteria:

Minor patient

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: DIDIER RAOULT, MD +33 413732401 didier.raoult@gmail.com
Contact: CECILE LAVOUTE, PHD +33 491381878 cecile.lavoute@ap-hm.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03606031
Other Study ID Numbers 2018-26
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators
Study Director: EMILE GARRIDO PRADALIE APHM
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date June 2018