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Microbiome Individuality and Stability Over Time

Microbiome Individuality and Stability Over Time

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04740684
Acronym
MISO
Enrollment
21
Registered
2021-02-05
Start date
2018-08-06
Completion date
2019-02-11
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet

Brief summary

Microbial derived uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) are present in blood and excreted into the urine. Uremic solutes have high inter-individual variability of unclear etiology, that the investigators hypothesize is due to intestinal microbiome variation and/or dietary variation between people. In this study, the investigators will collect baseline samples on participant's habitual diet. The investigators will then administer a homogenous diet to all participants for 7 days and examine levels of uremic solutes in the urine via 24-hour urine collection during this period. In parallel, the investigators will monitor microbiome composition. The investigators predict that during the period subjects are consuming the same, homogenous diet, their excretion of uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) into the urine will have less inter-individual variation.

Detailed description

Participants will be asked to eat exactly the same meal for one week and to eat this same meal three times each day. Subjects will be allowed to eat as much of this meal as they want and to eat enough so that they do not lose weight. The food will provide a nutritionally adequate diet, designed by a registered dietitian. Participants will be asked not to eat anything else including candy, snacks, etc. and not to drink anything except water including coffee, tea, sodas, or alcoholic drinks. Samples will be collected at 5 time points: 2 weeks prior to starting test diet, Baseline (day 1 on diet), day 4 on the diet, day 7 on the diet, 7 days after end of diet. Samples collected include: Blood sample Stool sample 24 hr urine collection Diet and Gastrointestinal questionnaires

Interventions

Standardized diet is prepared in a commercial kitchen and packaged in single serve portions to provide to participants to consume for 7 days

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

All participants will consume the exact same diet for one week. Samples will be collected before, during and after the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy individuals

Exclusion criteria

* pregnancy * diabetes * gastrointestinal disease * use of medications thought by the investigators to have a significant effect on the microbiome

Design outcomes

Primary

MeasureTime frameDescription
Uremic solute variability2 years25% reduction of the coefficient of variation of 24hr urinary excretion of at least 1 of 3 uremic solutes (p-cresol sulfate, indoxyl sulfate or phenylacetylglutamine) measured in mg/day/1.73 during the homogenous diet period as compared to the baseline/habitual diet period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026