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New treatment option for Inflammatory Bowel Disease
Official title The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
ClinicalTrials.gov ID: NCT03615690
What this study is testing
- What it's testing
- The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7)
- Age of 18-70 at start of study (inclusive)
You likely can't join if
- Women who are pregnant or nursing or expect to be pregnant
- Individuals allergic to nuts
- Individuals with a body mass index (BMI) lower than 18
- Individuals diagnosed with a serious medical condition as defined by the patient's physician, unless approved in writing by a physician
- Individuals who have been severely weakened by a disease or medical procedure,
- Individuals who are taking medication which may not be safely consumed with a calorie restricted diet
See the full eligibility criteria
- Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7)
- Age of 18-70 at start of study (inclusive)
- Women who are pregnant or nursing or expect to be pregnant
- Individuals allergic to nuts
- Individuals with a body mass index (BMI) lower than 18
- Individuals diagnosed with a serious medical condition as defined by the patient's physician, unless approved in writing by a physician
- Individuals who have been severely weakened by a disease or medical procedure,
- Individuals who are taking medication which may not be safely consumed with a calorie restricted diet
- Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemia
- Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
- Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)
- Individuals with a history of syncope
- Individuals with dietary needs incompatible with the FMD meal plan
- Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet.
- Patients on a caloric restricted diet will also be excluded.
- Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.