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Transplantation of Fecal Microbiota for Clostridium Difficile Infection

Primary Purpose

Clostridium Difficile Infection

Status

Unknown status

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Fecal Microbiota transplantation.

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Clostridium Difficile Infection, Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age>18 years.
A negative pregnancy test at inclusion, and a commitment to use contraception for a period of six months from the date of transplant.
At least one of the following conditions :
1. An evidence of Clostridium infection recurrence within 6 months after completion of antibiotic course acceptable, which will include at least 10 days of treatment Bmtronidzol a total dose of 500 mg x3 per day and / or Bonkomitzin dose of at least 125 mg 4x a day .
  Recurrence of infection is defined clinical and laboratory :
  - ≥ 3 diarrhea per day for at least two days in a row or ≥ 8 loose stools a day for 48 hours.
  - a positive stool test for Clostridium Difficile toxin, or PCR / antigen detection.
2. First infection not responding to antibiotics (at least 10 days Metronidazole dosage of 1500 mg per day , or Bonkomitzin total dose of at least 500 mg per day).
3. A first infection in a patient who is intolerant or allergic to Lonkomitzin and metronidazole.

Exclusion Criteria:

Participation in another clinical study.
Inability to provide informed consent.
A pregnant woman or breastfeeding.
Severe neutropenia - below 500 neutrophils (blood counts).
A significant immunosuppression (SCID, CVID, GVHD, using different preparations Aimonosofrsibiim , including prolonged corticosteroid therapy at doses equivalent to ≥ 20 mg prednisone per day for more than 4 weeks).
Status of SIRS or hemodynamic/respiratory instability.
Toxic Megacolon, ischemic colitis, Fulminant colitis or a higher than usual risk of colon perforatin during colonoscopy.
HBV infection or hepatitis C or HIV.
The use of antibiotics for the treatment of another disease at the time of inclusion.
A history of previous or current autoimmune disease, a progressive/an uncontrolled disease of the kidney/liver/hematological system/endocrine system/ heart/neurological system, or a metabolic disease.
An addiction to alcohol or drugs.

Sites / Locations

Gastroenterology Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal microbiota transplantation

Arm Description

Fecal microbiota transplantation during colonoscopy.

Outcomes

Primary Outcome Measures

Clinical remission

Less than 3 bowel movements a day

Secondary Outcome Measures

Negative lab test for Clostridium Difficile

No evidence for Clostridium Difficile in stool test.

Full Information

NCT ID

NCT01958463

First Posted

October 6, 2013

Last Updated

October 8, 2013

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01958463

Brief Title

Transplantation of Fecal Microbiota for Clostridium Difficile Infection

Official Title

Transplantation of Fecal Microbiota for Clostridium Difficile Infection

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection. The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.

Detailed Description

Infections by Clostridium Difficile are common both in the community and among hospitalized patients. It is mostly prevalent following an antibiotic treatment. In recent years the investigators are witnessing an increase in severity, incidence and treatment-resistant cases. Treatment-resistant infection or recurrent infection put the patient at risk for severe complications, such as perforation, septic shock, megacolon and even death. New antibiotic treatments such as Rifaximin and Fidaxomicin are not yet available for routine use in Israel. It is known that normal intestinal microbiota protect against Clostridium Difficile infections, and as early as 1958, researchers have demonstrated that a transplantation of fecal microbiota had a beneficial effect on Clostridium Difficile Infection. In fact, previous data show that microbiota transplantation during colonoscopy, in patients with treatment-resistant infection or recurrent infections, is an effective method with a 90% success rate in a single treatment. The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile Infection

Keywords

Clostridium Difficile Infection, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fecal microbiota transplantation

Arm Type

Experimental

Arm Description

Fecal microbiota transplantation during colonoscopy.

Intervention Type

Procedure

Intervention Name(s)

Fecal Microbiota transplantation.

Intervention Description

Fecal Microbiota transplantation during colonoscopy.

Primary Outcome Measure Information:

Title

Clinical remission

Description

Less than 3 bowel movements a day

Time Frame

8 weeks after treatment

Secondary Outcome Measure Information:

Title

Negative lab test for Clostridium Difficile

Description

No evidence for Clostridium Difficile in stool test.

Time Frame

8 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age>18 years. A negative pregnancy test at inclusion, and a commitment to use contraception for a period of six months from the date of transplant. At least one of the following conditions : An evidence of Clostridium infection recurrence within 6 months after completion of antibiotic course acceptable, which will include at least 10 days of treatment Bmtronidzol a total dose of 500 mg x3 per day and / or Bonkomitzin dose of at least 125 mg 4x a day . Recurrence of infection is defined clinical and laboratory : ≥ 3 diarrhea per day for at least two days in a row or ≥ 8 loose stools a day for 48 hours. a positive stool test for Clostridium Difficile toxin, or PCR / antigen detection. First infection not responding to antibiotics (at least 10 days Metronidazole dosage of 1500 mg per day , or Bonkomitzin total dose of at least 500 mg per day). A first infection in a patient who is intolerant or allergic to Lonkomitzin and metronidazole. Exclusion Criteria: Participation in another clinical study. Inability to provide informed consent. A pregnant woman or breastfeeding. Severe neutropenia - below 500 neutrophils (blood counts). A significant immunosuppression (SCID, CVID, GVHD, using different preparations Aimonosofrsibiim , including prolonged corticosteroid therapy at doses equivalent to ≥ 20 mg prednisone per day for more than 4 weeks). Status of SIRS or hemodynamic/respiratory instability. Toxic Megacolon, ischemic colitis, Fulminant colitis or a higher than usual risk of colon perforatin during colonoscopy. HBV infection or hepatitis C or HIV. The use of antibiotics for the treatment of another disease at the time of inclusion. A history of previous or current autoimmune disease, a progressive/an uncontrolled disease of the kidney/liver/hematological system/endocrine system/ heart/neurological system, or a metabolic disease. An addiction to alcohol or drugs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zamir Halpern, MD

Phone

972-36974282

halpernza@tlvmc.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zmir Halpern, MD

Organizational Affiliation

Tel-Aviv Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gastroenterology Institute

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noya Horowitz, PhD

Phone

972-3-6974297

noyah@tlvmc.gov.il

12. IPD Sharing Statement

Learn more about this trial

Transplantation of Fecal Microbiota for Clostridium Difficile Infection

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