Dogs as Probiotics

Completed · Phase 2

Conditions studied: Health of the Human Microbiome

In brief

Studies show that family members share as much or more of the composition of their microbiota (the trillions of micro-organisms in our guts) with their dogs as they do with each other (Song et. al. 2013). This shows that the introduction of dogs into home environments has a profound impact on the human microbiota. Additionally, many studies show that children raised with dogs are less likely than others to develop a range of immune-mediated disorders, including asthma and allergies (Ownby, Johnson, and Peterson 2002; Almqvist et al. 2003; Havstad et al. 2011). This suggests that dogs can serve as probiotics for children by appropriately training their immune systems not to produce inflammation in response to harmless stimuli. What is not known, however, is whether the same is true for elderly populations and dogs. Thus, this study seeks to explore whether dogs might also improve the physical and mental health of elderly adults by improving the structure and function of their microbiota. The investigators propose a pilot/proof of concept study to investigate whether dogs might improve the physical and mental health of elderly adults via changing (improving) the structure and function of their microbiota (gut flora). The investigators propose a pre-post study design that among 20 elderly individuals (aged 50 and older) to investigate the probiotic effect that dogs might have on these individuals. The investigators are particularly interested to know whether introducing a dog into a home where one has not lived in the recent past increases the "positive" microorganisms in the guts of the humans living with them. The investigators will also measure the changes in markers of inflammation (from blood samples) as well as the changes in self-reported scores of depression, frailty, physical activity, and general health and well-being mobility among human participants. In order to assess any effects in the animal study participants, the investigators will also collect and analyze fecal and blood samples as well as conduct home visits to observe canine and human interactions and bonding and conduct assessments of canine well-being using questionnaires/observational techniques that have been validated for these purposes in other studies. Additionally, the investigators will assess the interactions between of the participants with the dog and how having a dog in the home may influence an individual's relationship with the dog and his/her thoughts about the microbiota, human and canine health and human-animal interactions through monthly semi-structured interviews. The investigators have previously received IACUC approval for this study, approval number 14-537.

Key facts

Study ID: NCT02343731
Run by: University of Arizona
People needed: 20
Starts: 2015-01-01
Expected to finish: 2015-09-01
Last updated by the study team: 2016-01-12

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or females aged 50 - 80.
In general good health (mobile and able to care for a dog).
Have not taken antibiotics in the last six months.
Have not had a dog in the home for the past six months.
Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
Able to communicate in English with study personnel.
Willing to commit to fostering a dog for at least three months with the understanding that at the end of the three months, they can keep the dog if they so desire.

You may not qualify if…

Individuals who are currently on any antibiotic therapy. Participants who are on an antibiotic therapy will be allowed to participate in the study after a six month washout period.
Unwilling to have a dog in the home for at least three months of time.
Any of the following diagnoses, as identified by the intake evaluation conducted or study assessments:
o History of any of the following mental illnesses: schizophrenia, bipolar I disorder, drug or alcohol abuse active within 6 months of study entry. Determination of these criteria will be by self-report at screening interview
Subject has a medical condition or disorder that:
Is unstable and clinically significant, or:
Specifically impact immune functioning of the GI tract including Crohn's disease and ulcerative colitis
Require either chronic or periodic antibiotic treatment
Could interfere with the accurate assessment of safety or efficacy of the clinical assessments, including:
Individuals with any:
o Current participation in any clinical trial that might impact results of this one, which includes participation in another clinical trial where any experimental drugs are being taken as well as studies / drug trials with agents that might affect mood and or the gastrointestinal tract.
Reasonable likelihood for non-compliance with the protocol for any other reason, in the opinion of the Investigator, prohibits enrollment of subject into the study.
Any clinically significant autoimmune disease (compensated hypothyroidism allowed)

Where it is running

University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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