Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease

Stopped early · Phase 1

Conditions studied: Alzheimer Disease

In brief

The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention for Alzheimer's disease (AD).

Key facts

Study ID

NCT03998423

Run by

University of Wisconsin, Madison

People needed

5

Starts

2019-11-14

Expected to finish

2020-07-14

Last updated by the study team

2020-07-24

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Current enrollment in the Wisconsin ADRC clinical core study (2011-0030), ADCP (26695, MCW IRB), or referred from clinic
• At least 45 years of age
• Good general health (other than dementia) with no conditions/medications affecting the gut microbiome (see exclusion criteria below)
• Willing and able to comply with all study procedures for the duration of the study
• Able to provide signed and date informed consent form
• Participant is not pregnant, lactating or of childbearing potential (ie women must be two years post-menopausal or surgically sterile
• Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception
• Able to take oral medications
• Able to take the test capsule successfully with no signs or symptoms of dysphagia
• Additional inclusion criteria for participants with Alzheimer's disease:
• Abnormal memory function documented by neuropsychological testing
• Wisconsin ADRC (HS IRB# 2015-0030) Consensus Diagnosis Conference indicates probable AD diagnosis as per NINDS/ADRDA criteria for probable AD (for ADRC and ADCP participants only).

You may not qualify if…

• Active or previous (within 6 months) participation in an Alzheimer's clinical intervention/trial
• Significant neurologic disease: Any significant neurologic disease, such as Parkinson's disease, stroke, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, subdural hematoma, multiple sclerosis, seizure disorder, or other significant deficits (other than Alzheimer's dementia)
• Alcohol/substance: history of alcohol/substance dependence since joining the cohort
• Psychiatric disorders: Untreated current axis 1 DSM-V disorder such as major untreated depression, current untreated bipolar 1 disorder, untreated schizophrenia spectrum disorders, or other conditions potentially affecting study adherence.
• Significant medical illness: any significant systemic illness or unstable medical condition occurring that could affect cognition (other than Alzheimer's). Examples include malignant cancer, chemotherapy, untreated thyroid disease, heart failure, or renal insufficiency.
• Illiterate, blind, or non-English speaking
• Known periodic antibiotic use (i.e. prior to dental appointments)
• Oral FMT-specific exclusion criteria:
• Inability (e.g. dysphagia) or unwilling to swallow capsules - assessed using the Eating Assessment Tool (EAT-10) and bedside 3oz water swallow test administered by CRU nurse or study coordinator
• Active gastrointestinal infection at time of enrollment
• Known or suspected toxic megacolon and/or known small bowel ileus
• History of total colectomy or bariatric surgery
• Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy
• Unable or unwilling to comply with protocol requirements
• Expected life expectancy < 6 months
• Previous FMT or microbiome-based products at any time excluding this study
• Patients with severe anaphylactic or anaphylactoid food allergy
• Solid organ transplant recipients ≤ 90 days post-transplant or on active treatment for rejection
• Immunocompromised/ at risk of CMV/EBV associated disease
• A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study
• Exclusionary factors affecting the microbiome:
• Use of systemic antibiotics (intravenous, intramuscular, or oral) in the previous 3 months
• Oral, intravenous, intramuscular, nasal or inhaled corticosteroids (except PRN use for allergies)
• Immune stimulating medications
• Methotrexate or immunosuppressive cytotoxic agents

Where it is running

• University of Wisconsin - Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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