Hormonal Influences on Inflammatory Bowel Diseases

Summary

Of the 1.8 million females with inflammatory bowel diseases (IBD) in the US, over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled. Despite the significant impact that cyclical IBD symptoms, such as abdominal pain, diarrhea, and fatigue have on quality of life, evidence about how to alleviate these symptoms is lacking. In other chronic conditions which are hormonally influenced, such as epilepsy, hormonal contraception may be used to favorably impact disease-related symptoms associated with menses and improve quality of life. In our previous cross-sectional study, 47% of the levonorgestrel intrauterine device users and 19% of combination oral contraceptive users reported improvement in their cyclical IBD symptom. All hormonal methods may plausibly improve symptoms, but prospective, rigorous data evaluating their efficacy for this purpose are lacking. In order to design a future comparative effectiveness trial on the effect of hormonal contraceptive methods on menstrual-related IBD symptoms, we propose this pilot prospective cohort study of 200 females with IBD: 100 naturally cycling and 100 hormonal contraception users. We will gain essential knowledge on IBD-specific influences on contraceptive method selection, willingness to be randomized to methods, the ability of IBD patient reported outcome (PRO) instruments to differentiate between non-menstrual and menstrual-related IBD symptoms, and assess the potential role of inflammatory markers as outcome measures in future trials. We will recruit participants from the University of Utah IBD Center and clinics, other Utah gastroenterology providers, and through social media ads. Total study commitment will be \~12 weeks. Study activities will include daily and weekly text message surveys, as well as blood draws and fecal samples for inflammatory markers in a subset of participants which are commonly used for IBD management. Our aims include: (1) To identify preferences and reasons for contraceptive method selection (or non-use) and willingness to participate in a randomized controlled trial, to inform feasibility of a future trial, (2) To obtain estimates of means and standard deviations for the validated Crohn's Disease and Ulcerative Colitis PRO Instruments by menstrual timing in naturally-cycling participants and between bleeding and non-bleeding days in hormonal contraception users, and (3) To assess correlation between inflammatory marker changes (fecal calprotectin \& high sensitivity C-reactive protein), menstrual timing or bleeding/non-bleeding days, and IBD PRO responses, in a subset of 30% of Aim 1 participants. This pilot will inform a future trial design to define non-contraceptive benefits of hormonal contraception on cyclical IBD symptoms. This line of inquiry will allow for an adjuvant approach for IBD symptom management that is sex-specific and addresses both concerns for hormonal triggers and the need for highly-effective contraception for those who desire it.

Conditions

• Inflammatory Bowel Diseases
• Contraception
• Menstrual Problem

Interventions

OTHER

Proposed study design and randomization scenarios

Present hypothetical study scenarios and assess willingness to be randomized based on the adapted 7-item Attitudes to Randomized Trials Questionnaire

OTHER

Repeated measures of validated Inflammatory Bowel Disease Patient Reported Outcome Instruments

We will electronically administer Ulcerative Colitis (UC) and Crohn's Disease validated PRO instruments, including the daily symptom modules and weekly quality of life modules for 12 weeks to all 200 participants

OTHER

Inflammatory marker collection and assessment for correlation with PRO responses and menstrual timing

In an Aim 3 sub study of 30% of participants, we will collect inflammatory markers commonly used to assess disease activity and risk of relapse in inflammatory bowel disease patients, including weekly blood samples of high sensitivity c-reactive protein (13 total) and monthly ferritin, albumin, and WBC, as well monthly stool specimens (4 total) for fecal calprotectin

Sponsors & Collaborators

• University of Utah

  lead OTHER

Principal Investigators

• Lori Gawron · University of Utah

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2025-12-09

Completion

2025-12-09

Countries

• United States

Study Locations