CompletedNo phase
Elemental Diet and Gut Microbiome
Key facts
- Who runs it
- Cedars-Sinai Medical Center
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 6 Aug 2023
- Ended
- 14 Dec 2023
- Type of study
- Interventional
- Treatments tested
- Elemental Diet
- Record updated
- 23 January 2024
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- • 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
Who cannot take part
- • 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
Where in United States
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
About the trial
What the trial wants to find out
he primary objective of this study is to assess changes in stool microbiome profiles in patients after an elemental diet.
The group in the trial
- elemental dietTreatment being tested
subjects will be using the elemental diet packets daily. Subjects who are positive for excessive methane (i.e. methane level\>10 ppm) will be required to complete a single daily fasting methane measurement (SMM) for the duration of the 14 days.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 23 January 2024