MISO: Microbiome Individuality and Stability Over Time

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04740684
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet	Other: Standardized diet	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will consume the exact same diet for one week. Samples will be collected before, during and after the intervention.All participants will consume the exact same diet for one week. Samples will be collected before, during and after the intervention.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Microbiome Individuality and Stability Over Time
• Actual Study Start Date: Aug 6, 2018
• Actual Primary Completion Date: Feb 11, 2019
• Actual Study Completion Date: Feb 11, 2019

Outcome Measures

Primary Outcome Measures

1. Uremic solute variability [2 years]

   25% 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Timothy Meyer, Professor of Nephrology, Stanford University
• ClinicalTrials.gov Identifier: NCT04740684
• Other Study ID Numbers: 44718
• First Posted: Feb 5, 2021
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 7, 2021