Transplantation of Fecal Microbiota for Clostridium Difficile Infection

NCT01958463 | Unknown Phase 3

• 1 other identifier: TASMC-12-ZH-500-CTIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infection

Keywords

Clostridium Difficile Infection; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  Less than 3 bowel movements a day

  8 weeks after treatment

Secondary Outcomes (1)

• Negative lab test for Clostridium Difficile

  8 weeks after treatment

Study Arms (1)

Fecal microbiota transplantation

EXPERIMENTAL

Fecal microbiota transplantation during colonoscopy.

Procedure: Fecal Microbiota transplantation.

Interventions

Fecal Microbiota transplantation. PROCEDURE

Fecal Microbiota transplantation during colonoscopy.

Fecal microbiota transplantation

Eligibility Criteria

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

You may qualify if:

• age\>18 years.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Gastroenterology Institute

Tel Aviv, Israel, 64239, Israel

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Zmir Halpern, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zamir Halpern, MD

CONTACT

972-36974282; halpernza@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2013
• First Posted: October 9, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

IL (1)