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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