Chapel Hill, NCNCT07337902Now EnrollingIRB Ready

Crohn's Disease (CD) Clinical Trial in Chapel Hill, NC

Access cutting-edge crohn's disease (cd) treatment through this clinical trial at a research site in Chapel Hill. Study-provided care at no cost to qualified participants.

Sponsored by University of North Carolina, Chapel Hill

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Expert Care in Chapel Hill

Access crohn's disease (cd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related crohn's disease (cd) treatment provided free

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Check if you qualify for this crohn's disease (cd) clinical trial in Chapel Hill, NC

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Why Participate?

  • No-Cost Study Care

  • Local to Chapel Hill

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Chapel Hill site if eligible
  4. 4Begin participation

About This Crohn's Disease (CD) Study in Chapel Hill

The purpose of this pilot study is to prepare for a larger study that will compare the effectiveness and safety of two common pain medications, ibuprofen and acetaminophen, to help treat period cramps in women with Crohn's disease. The goal of this study is to identify any challenges in running a larger study. The investigators will track how many people sign up for the study, how well participants follow the study plan, how many people stay in the study, and whether they are able to complete all the study activities, such as taking the medication, submitting samples, and filling out surveys. During the study, participants will undergo a screening visit that includes a blood draw, physical exam, pregnancy test, stool testing, and complete surveys about Crohn's disease and menstrual cycles. Once this visit is complete, the rest of the study will occur at home. Participants will be assigned to take either ibuprofen or acetaminophen to help treat period cramps for four menstrual cycles in a row. Participants will take ibuprofen for two cycles and acetaminophen for two cycles. Participants will know which medication is being taken at any given time, but the order in which they take the medications will be randomly assigned. Before each menstrual cycle, participants will submit a stool sample and fill out a short (\<1 minute) electronic survey. When participants develop period cramps, they will take the assigned medication for three days and fill out short (\<1 minute) electronic surveys about their cramps. After participants finish taking the medication for three days, they will submit another stool sample and fill out two more short (\<1 minute) electronic surveys. After have completing this process for four menstrual cycles, a remote interview with a researcher to give feedback on the study will be conducted.

Sponsor: University of North Carolina, Chapel Hill

Who Can Participate

Inclusion Criteria

Ages 18-44 years
Assigned female at birth
Crohn's Disease (CD) diagnosis
In stable clinical remission from CD, defined as a short Crohn's Disease Activity Index (CDAI; See Table 3) \<150 without use of corticosteroids
Self-reported primary dysmenorrhea
Regular menstrual cycles occurring every 23-35 days
Using an appropriate contraceptive method or abstinence

Exclusion Criteria

Any of the following conditions: endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids/polyps, chronic pelvic inflammatory disease, a history of pelvic surgery including hysterectomy, any other pathological pelvic conditions, or current pregnancy
Plans to become pregnant during the study period
Use of an oral contraceptive for less than 3 months, on an unstable oral contraceptive dose within the last 3 months, switched from one oral contraceptive to another within the last 3 months or intend to do so during the course of the trial
Taking hormone therapy including estrogen or progesterone that is not part of a hormonal contraceptive
Known hypersensitivity or contraindication to ibuprofen or acetaminophen
Inability to complete REDCap questionnaires (including confusion despite training and/or lack of smart phone and/or computer access).
Not able to speak and read English language.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chapel Hill?

Yes, this clinical trial (NCT07337902) has an active research site in Chapel Hill, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Crohn's Disease (CD) Treatment Options in Chapel Hill, NC

If you're searching for crohn's disease (cd) treatment options in Chapel Hill, NC, this clinical trial (NCT07337902) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chapel Hill research site is actively enrolling participants for this clinical trial. You'll receive care from experienced crohn's disease (cd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all crohn's disease (cd) clinical trials near you to find additional studies recruiting in your area.

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