Digestive Microbiota Transplant

NCT03606031 | Unknown

• 1 other identifier: 2018-26
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile; Antibiotic Resistant Infection; Chronic Diarrhea of Unknown Origin

Outcome Measures

Primary Outcomes (2)

• graft indications

  * Clostridium difficile diarrhea * Carriage of antibiotic-resistant bacteria * Unexplained chronic diarrhea

  1 days

• recidive events

  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

  6 months

Secondary Outcomes (1)

• Duration of hospitalization

  up to 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Minor patient

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13005, France

RECRUITING

Study Officials

• EMILE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

DIDIER RAOULT, MD

CONTACT

+33 413732401; didier.raoult@gmail.com

CECILE LAVOUTE, PHD

CONTACT

+33 491381878; cecile.lavoute@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 30, 2018
• Study Start: March 23, 2018
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: July 30, 2018

Record last verified: 2018-06

Locations

FR (1)