Fecal Microbiota Transplantation (FMT) in Clostridium Difficile Infection (CDI) Not Responding to Antibiotics

NCT03117582 | Completed

• 1 other identifier: 16-2283
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To study the changes in the microbiome and stool composition in patients with Clostridium Difficile Infection (CDI) who undergo Fecal Microbiota Transplantation (FMT), along with changes in their clinical characteristics.

Conditions

Clostridium Difficile

Keywords

C. diff; CDI; Clostridium Difficile Infection; Diarrhea; Fecal microbiota transplantation; FMT

Outcome Measures

Primary Outcomes (1)

• Percent of participants who had resolution of diarrhea.

  Diarrhea is defined as three or more unformed stools for more than two consecutive days.

  8 weeks after FMT procedure

Secondary Outcomes (3)

• Percent of participants who did not need antibiotics to treat diarrhea.

  8 weeks after FMT procedure

• Difference in stool microbiome before and after FMT procedure.

  6 months after FMT procedure

• Difference in stool metabolome before and after FMT procedure.

  6 months after FMT procedure

Study Arms (1)

Patients with C.diff infection

Patients with C.diff infection not responding to antibiotics who are now scheduled for the FMT procedure for routine care of their condition.

Other: Stool specimen

Interventions

Stool specimen OTHER

The following stool specimen will be collected for this study: 1. 4, 3mL stool specimen from patient 2. 1, 25mL stool aliquot from donor

Patients with C.diff infection

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are receiving FMT procedure at UNCH and meet the eligibility criteria below:

You may qualify if:

• As subjects must meet standard clinical criteria for candidacy for FMT, all patients will have suffered symptomatic diarrhea and have documented stool c. difficile toxin positivity. Almost all patients will have failed standard therapy for CDI, which includes at least one course of treatment with a primary agent (metronidazole, vancomycin or fidaxomicin), as well as an extended vancomycin taper following either the second or third recurrence. There may be extenuating circumstances that could justify FMT for CDI outside of these parameters, such as severe allergy to multiple of the above agents, though this would be expected to be exceedingly rare.
• All patients must be able to tolerate either colonoscopy (including anesthesia and sedation) or placement of a nasogastric/nasoduodenal tube, without a contraindication to the procedure.

You may not qualify if:

• Pregnancy
• Prisoners (for concerns of vulnerability and logistics)
• Adult patients who are themselves unconsentable at time of FMT.
• Life expectancy judged to be \<3 months
• Need for extended antibiotics at baseline, for an indication other than treatment for CDI
• Any patient who the clinician judges to be a poor candidate for FMT, for reasons of comorbidities or not being able to tolerate the procedure for administration, would by definition be excluded from the study.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator
• North Carolina State University: collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

donor stool (25mL aliquot) stool specimen (4 samples, each \~3mL)

MeSH Terms

Conditions

Clostridium Infections; Diarrhea

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ajay S Gulati, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: April 18, 2017
• Study Start: December 1, 2016
• Primary Completion: May 2, 2020
• Study Completion: December 11, 2020
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

US (1)