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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

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.


Condition or disease
Clostridium Difficile Antibiotic Resistant Infection Chronic Diarrhea of Unknown Origin

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Observational Study in Patients Receiving a Digestive Microbiota Transplant According to a Standardized Protocol
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea




Primary Outcome Measures :
  1. graft indications [ Time Frame: 1 days ]
    • Clostridium difficile diarrhea
    • Carriage of antibiotic-resistant bacteria
    • Unexplained chronic diarrhea

  2. 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



Secondary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: up to 3 months ]
    beginning and end of hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606031


Contacts
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Contact: DIDIER RAOULT, MD +33 413732401 didier.raoult@gmail.com
Contact: CECILE LAVOUTE, PHD +33 491381878 cecile.lavoute@ap-hm.fr

Locations
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France
Assistance Publique Des Hopitaux de Marseille Recruiting
Marseille, Paca, France, 13005
Contact: CECILE LAVOUTE, PHD    33 491381878    cecile.lavoute@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILE GARRIDO PRADALIE APHM

Additional Information:

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03606031     History of Changes
Other Study ID Numbers: 2018-26
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms