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Elemental Diet for Irritable Bowel Syndrome

N/A
Waitlist Available
Led By Bianca Chang, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will study how a special diet changes gut bacteria in patients.

Who is the study for?
This trial is for adults aged 18-85 with Irritable Bowel Syndrome who suspect they have SIBO, as indicated by specific breath tests. They must not be pregnant or lactating, have diabetes, active infections requiring antibiotics recently, or a history of PKU disease. Participants should agree to use birth control and understand the study.Check my eligibility
What is being tested?
The trial is testing how an elemental diet affects the gut microbiome in patients with IBS. The primary focus is on observing changes in stool microbiome profiles after following this special diet.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include digestive discomfort or nutritional deficiencies due to the restrictive nature of an elemental diet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
assess changes in stool microbiome profiles

Trial Design

1Treatment groups
Experimental Treatment
Group I: elemental dietExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elemental Diet
2023
N/A
~30

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,827 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
346 Patients Enrolled for Irritable Bowel Syndrome
Bianca Chang, MDPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

Elemental Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05978973 — N/A
Irritable Bowel Syndrome Research Study Groups: elemental diet
Irritable Bowel Syndrome Clinical Trial 2023: Elemental Diet Highlights & Side Effects. Trial Name: NCT05978973 — N/A
Elemental Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05978973 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility criteria for this experiment restricted to adults under 40, or are older individuals admitted as well?

"This medical trial seeks to include individuals between the ages of 18 and 85. There are a total of 16 trials for minors, and 91 for elderly patients."

Answered by AI

Are there opportunities to volunteer for this scientific exploration?

"Clinicaltrials.gov reveals that the recruitment process is still open, with the trial being initially posted on August 6th 2023 and last altered two days later."

Answered by AI

To what extent is the scope of this research project expanding?

"Yes, the details posted on clinicaltrials.gov demonstrate that this study is currently open for enrollment. This research was first made available on August 6th 2023 and last modified two days later. Across one medical centre, 30 volunteers must be enrolled in order to conduct the trial as planned."

Answered by AI

What prerequisites must a person meet to be eligible for this experiment?

"This medical trial is searching for 30 people suffering from irritable bowel syndrome aged between 18 and 85. Essential criteria include the ability to understand and provide informed consent, gender-specific protocols regarding reproductive potential (including pregnancy tests) and methane/hydrogen levels higher than 20ppm/10ppm during LBT testing within a 90 minute or 120 minute window respectively."

Answered by AI

Who else is applying?

What site did they apply to?
Cedars-Sinai Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve tried one drug and a low FODMAP diet in the past 20 years and still experiencing symptoms and suspect I have a sensitivity to gluten that does not show up on test.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Elemental Diet and Gut Microbiome
Bianca Chang 2023. "Elemental Diet and Gut Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05978973.
~18 spots leftby Apr 2025
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