Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00951756
Eligibility Criteria:
Inclusion Criteria:
1. Participant is capable of giving informed consent
2. Participant is age 18 to 40 years
Exclusion Criteria:
1. Diagnosis with Inflammatory bowel disease (IBD), celiac disease, or other chronic intestinal disorders.
2. Baseline bowel frequency less than every 2 days or greater than 3 times daily.
3. Current smoker.
4. Body Mass Index (BMI) \<18.5 of \>35.
5. Diabetes mellitus (DM)
6. Diagnosis with coronary artery disease, congestive heart failure, or prior myocardial infarction.
7. History of dyslipidemia or receiving treatment for hypercholesterolemia. This will be defined as a fasting LDL \>160 mg/dL or a non-fasting total cholesterol \>200 mg/dL or non-fasting HDL\<40 mg/dl. Additionally, patients receiving drug therapy for hypercholesterolemia will be excluded.
8. Prior bowel resection surgery.
9. Contraindication to flexible sigmoidoscopy and biopsies. Patients with suppressed white blood count may be at increased risk of systemic infection following sigmoidoscopy with biopsies. As such, subjects with a white blood cell (WBC) count less than 3,500 or an absolute neutrophil count of less than 1,000 will be excluded. Patients with thrombocytopenia or with a coagulopathy may be at increased risk of bleeding complications after colonoscopic biopsies. As such, patients with a platelet count of less than 100,000 or an international normalized ratio (INR) greater than 1.2 will be excluded from the study.
10. Student or employee of any one of the investigators.
11. Pregnant women.
12. Use of antibiotics in the prior 6 months.
13. Use of antacids, non-steroidal anti-inflammatory drugs (NSAIDs), or dietary supplements in the preceding 2 weeks.
14. Use of any of the following medications in the 4 weeks prior to randomization: proton pump inhibitors (PPI), histamine receptor antagonists, narcotics, tricyclic antidepressants, anticholinergics (e.g., hyoscamine), metoclopramide, anti-diarrhea medications, laxatives.
15. HIV infection, AIDS, or other known conditions resulting in immunosuppression.
16. Allergies or intolerance to the components of the study diets.
17. Participant has experienced diarrhea within the two weeks prior to the first sigmoidoscopy. Diarrhea is defined as a change in bowel habits with an increased frequency or loose stools such that the stool could not be lifted with a fork.
18. Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00951756
Study Brief:
Protocol Section:
NCT00951756