Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria 1. Age ≥18 2. Documented diagnosis of Crohn's disease 3. sCDAI score >175 4. Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP. 5. Access to a computer with internet and the ability to complete daily online surveys 6. Capable of providing consent to participate 7. Able to receive weekly food shipments delivered every Friday for 6 weeks Exclusion Criteria 1. Pregnancy 2. sCDAI >400 3. Hospitalized patients 4. Anticipated need for surgery within 6 weeks of randomization 5. Use of the Specific Carbohydrate Diet within 4 weeks of screening 6. Start or change*** dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening 7. Start or change*** dose of anti-TNF agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening. 8. Start or change in dose of any 5-ASA medications within 2 weeks of screening. 9. Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent* 10. Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening 11. Known symptomatic intestinal stricture. 12. Presence of an ostomy 13. Baseline stool frequency >4 bowel movements/day when well 14. BMI <16 15. BMI ≥40 16. Celiac disease 17. Documented C difficile colitis within four weeks of screening 18. Diabetes Mellitus requiring medication 19. Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care) 20. Known allergy to tree nuts or peanuts 21. Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study. 22. Currently participating in another clinical trial of a drug to treat IBD or a dietary therapy for any indication.
- - Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose.
- - Loading/induction doses of biologic type medication will be considered a stable doses.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Pennsylvania|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|James D Lewis, MD, MSCE|
|Principal Investigator Affiliation||University of Pennsylvania|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Specific Carbohydrate Diet
Active Comparator: Mediterranean Style Diet
Other: - Diet
food for the diet will be provided to the participants for 6 weeks
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.