Status:
COMPLETED
Elemental Diet and Gut Microbiome
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
he primary objective of this study is to assess changes in stool microbiome profiles in patients after an elemental diet.
Detailed Description
The gut microbiome is the collection of microbes residing inside the gastrointestinal (GI) tract. The involvement of the gut microbiome has been demonstrated in multiple diseases processes including i...
Eligibility Criteria
Inclusion
- • Participant must be able to understand and provide informed consent
- Males and Females ≥18-85
- Female subjects of childbearing potential must have a negative pregnancy test upon study entry
- Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study
- Subject self-reports experiencing SIBO symptoms within 30 days
- Positive (abnormal) lactulose breath test for SIBO on visit 1 (day -7) as defined as:
- Rise of hydrogen ≥ 20ppm within 90 minutes on LBT OR
- A methane level ≥10 ppm at any point during the 120-minute LBT
Exclusion
- • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Pregnancy or lactating
- Type 1 or type 2 diabetes
- Active or ongoing infection that requires antibiotics other than the participants known prophylactic medications (i.e. active infection or antibiotic use in the last 1 month)
- Any condition that, in the opinion of the investigator, contraindicates participation in this study will be excluded from study participation.
- History of known Phenylketonuria (PKU) disease
- Non-English-speaking participants
Key Trial Info
Start Date :
August 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05978973
Start Date
August 6 2023
End Date
December 14 2023
Last Update
January 23 2024
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048