The Gut - PRO Study
Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a probiotic supplement taken by mouth is safe and practical to use. It is for adults age 60 or older with Alzheimer's dementia, mild memory or thinking problems due to Alzheimer's, or a risk of Alzheimer's dementia. The study will enroll 40 people, who may take part for up to 1 year.
The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 60 or older and referred by a Wisconsin clinic in the WAI network or recruited from the community.
- Have Alzheimer's dementia, mild cognitive impairment (mild memory or thinking problems), or no memory or thinking problems.
- If you have no thinking problems, score in the healthy range on the MOCA thinking test.
- If you have memory or thinking problems, have test results and a diagnosis that meet the study's rules for Alzheimer's or mild cognitive impairment due to Alzheimer's.
- Be in good general health, apart from memory or thinking problems, with no conditions or medicines that affect gut bacteria.
- Be willing and able to follow study steps, take medicines by mouth, and sign a dated consent form.
- Not be pregnant, breastfeeding, or able to become pregnant. Women must be at least 2 years past menopause or have had surgery that prevents pregnancy.
- Have someone who can answer questions about you.
Who can't join
- Taking part in another Alzheimer's treatment trial now or within the past 6 months, unless you were in its placebo or control group. Usual dementia care and Alzheimer's medicines, including antibody treatments, are allowed.
- Have a major brain or nerve disease other than Alzheimer's or mild cognitive impairment; a serious or unstable illness that could affect thinking; diabetes; or alcohol or drug dependence in the past year.
- Cannot read, are blind, do not speak English, cannot or will not swallow capsules, or cannot follow study rules.
- Use antibiotics regularly, or used antibiotics by mouth or injection within 3 months. Used probiotic supplements or gut-bacteria products within 2 months, including high-dose probiotics. Ordinary foods such as yogurt do not count; joining after the waiting period may be possible.
- Take medicines that boost or weaken the immune system, have a weakened immune system on blood tests, or made major diet changes in the past month.
- Have an active gut infection, uncontrolled bowel disease, ongoing unexplained diarrhea, or chronic constipation. Certain serious bowel swelling or blockages also rule you out.
- Had weight-loss surgery, removal of the whole colon, or a major bowel removal at any time; or major digestive tract surgery within 5 years, except gallbladder or appendix removal.
- Have a severe food allergy; receive certain active cancer treatments; had an organ transplant within 90 days or are being treated for rejection; are expected to live less than 6 months; or have another condition that could make the study unsafe or affect its results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * MCI/AD or cognitively unimpaired, referred from a Wisconsin clinic that is part of the Wisconsin Alzheimer's Institute's (WAI) network, or recruited from the community. May have participated in: * Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030) * ADCP (26695, MCW IRB) * Synapse study (2018-1283) * ADRC Recruitment Registry (2016-0735) * At least 60 years of age or older * Good general health (other than cognitive impairment/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 dated informed consent form * Participant is not pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile) * Able to take oral medications * An informant to answer questionnaires about the participant Additional inclusion criteria for unimpaired participants: * Has MOCA score that falls within the range defined for cognitively healthy individuals Additional inclusion criteria for participants with MCI/AD * Abnormal cognitive function documented by neuropsychological testing * ADRC (2015-0030) Consensus Diagnosis Conference indicates dementia or MCI due to AD (for ADRC, ADCP, and Synapse participants only) * Meets NIA-AA criteria for MCI or AD. Exclusion Criteria: * Active or previous (within 6 months) participation in an Alzheimer's clinical intervention/trial (can be included if previously enrolled in placebo or control group) * Standard clinical care for dementia and medications used to treat MCI and Alzheimer's disease are acceptable, including monoclonal antibody therapy * 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 or Mild Cognitive Impairment * Alcohol/substance: history of alcohol/substance dependence in the past year. * Significant medical illness: any significant systemic illness or unstable medical condition occurring during ADRC participation that could affect cognition (other than MCI/AD). Examples include malignant cancer, chemotherapy, HIV, untreated thyroid disease, heart failure, or renal insufficiency * Current diagnosis with diabetes * Illiterate, blind, or non-English speaking * Known periodic antibiotic use (i.e., prior to dental appointments) * Oral PS-specific exclusion criteria: * Inability (e.g., dysphagia) or unwilling to swallow capsules * 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 less than 6 months * Previous use of probiotic supplementation (PS) or microbiome-based products within 2 months, large doses of commercial probiotics consumed (greater than or equal to 10\^8 cfu or organisms per day). Includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply). Enrollment after 2 months without probiotic use can be considered for eligibility * Patients with severe anaphylactic or anaphylactoid food allergy * Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection * A condition that would jeopardize the safety or rights of the participant, would make it unlikely for the participant to complete the study, or would confound the results of the study * Exclusionary factors affecting the microbiome: * Previous use of systemic antibiotics (intravenous, intramuscular, or oral) within 3 months (depends on the duration of antibiotic use, i.e., less than 3 months is considered exclusion, however, enrollment after 3 months without antibiotic use can be considered for eligibility) * Immune stimulating and/or suppressing medications * Immunosuppressed as evaluated by complete blood count (CBC) with differential, which includes white blood cell count, total neutrophil count, and total lymphocyte count * Unstable dietary history during the previous month, which is defined as major changes in diet by eliminating or significantly increasing a major food group * Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years * Major bowel resection at any time * Active uncontrolled gastrointestinal disorders or disease including inflammatory bowel disease, ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (moderate-severe); persistent, infectious gastroenteritis, colitis, or gastritis; persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated), or chronic constipation
Study sites (1)
WI
- University of Wisconsin Hospitals and Clinics · Madison, WI 53792Barbara Bendlin, PhD · Principal investigatorFederico Rey, PhD · Principal investigatorMore trials in Madison