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Clinical Trials/NCT04758715
NCT04758715
Active, not recruiting
Not Applicable

Diet and Microbiome Longitudinal Monitoring With Food Intervention

University of Nebraska Lincoln1 site in 1 country65 target enrollmentFebruary 2, 2021
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ConditionsMicrobiome, HumanGastrointestinal Tract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Microbiome, Human
Sponsor
University of Nebraska Lincoln
Enrollment
65
Locations
1
Primary Endpoint
Microbiota variation
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.

Registry
clinicaltrials.gov
Start Date
February 2, 2021
End Date
February 28, 2030
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •willing to sign consent and have samples collected,
  • •able to read and speak English,
  • •participants must be willing to use an electronic food diary and consume study provided foods,
  • •only individuals able to provide a US address will be included.

Exclusion Criteria

  • •Subjects not able to sign consent on their own accord (ie requiring a Legally Authorized Representative \[LAR\]),
  • •Current parenteral nutrition,
  • •Received cancer treatment within past 6 months prior to signing consent,
  • •Taken antibiotic treatment within the past 1 month prior to signing consent,
  • •Received oral x-ray contrast within the past 1 month prior to signing consent,
  • •Received any type of gastrointestinal bowel preparation in the past 1 month prior to signing consent,
  • •History of organ transplant,
  • •Shellfish allergy,
  • •Insect allergy,
  • •Cacti allergy,

Outcomes

Primary Outcomes

Microbiota variation

Time Frame: Up to 2 weeks

Ecological statistics will be used to analyze the longitudinal microbiome composition modification

Study Sites (1)

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