A longitudinal observational study of patients with inflammatory bowel disease (IBD) and healthy control subjects to analyse the relationship between the menstrual cycle, psychosocial factors and the course of IBD.

A longitudinal observational study of patients with inflammatory bowel disease (IBD) and healthy control subjects to analyse the relationship between the menstrual cycle, psychosocial factors and the course of IBD. - CARMEN

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038247

Enrollment

Registered

2025-10-24

Start date

2026-06-08

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases (IBD), Crohn´s disease, Ulcerative Colitis

Interventions

Group 1: Patients with inflammatory bowel disease (IBD) - Longitudinal collection of PROMs, medication intake, IBD activity (including f-calprotectin) over a cumulative period of three menstrual cycle

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pre-existing inflammatory bowel disease (> 3 months). Active menstrual cycle (at least 3 menstrual periods during the past 6 months). Remission to moderate disease activity (HBI <17 points; SCCAI <12 points). Written consent of the patient after receiving full information.

Exclusion criteria

Exclusion criteria: Conditions that prevent the subject from understanding the nature and implications of the clinical trial and its possible consequences. Male sex. Known menopause. Pregnancy. Hormonal contraception.

Design outcomes

Primary

Measure	Time frame
Analysis of a correlation between menstrual cycle progression and IBD activity	—

Secondary

Measure	Time frame
Evaluation of a association between the timing of biologic or advanced therapy administration (relative to menstrual phase) and subsequent change in clinical disease activity, PROMs, and biochemical markers (e.g., fecal calprotectin). Assessment of associations between psychosocial factors (fatigue, depressive symptoms, perceived stress, quality of life, PMS/PMDD symptom burden) and IBD activity across the menstrual cycle. Identification of cyclical variations in physiological parameters (heart rate, heart rate variability, respiratory rate, activity, and sleep metrics) measured by wearable device (Garmin Forerunner 55) and their correlation with hormonal cycle phases. Evaluation of these parameters as potential surrogate markers of menstrual phase and/or disease activity in IBD and healthy controls. Evaluation of serum-based metabolic profiles at study entry and completion to identify biochemical correlates of hormonal fluctuation and disease modulation.	—

Measure

Time frame

Evaluation of a association between the timing of biologic or advanced therapy administration (relative to menstrual phase) and subsequent change in clinical disease activity, PROMs, and biochemical markers (e.g., fecal calprotectin). Assessment of associations between psychosocial factors (fatigue, depressive symptoms, perceived stress, quality of life, PMS/PMDD symptom burden) and IBD activity across the menstrual cycle. Identification of cyclical variations in physiological parameters (heart rate, heart rate variability, respiratory rate, activity, and sleep metrics) measured by wearable device (Garmin Forerunner 55) and their correlation with hormonal cycle phases. Evaluation of these parameters as potential surrogate markers of menstrual phase and/or disease activity in IBD and healthy controls. Evaluation of serum-based metabolic profiles at study entry and completion to identify biochemical correlates of hormonal fluctuation and disease modulation.

—

Countries

Germany

Contacts

Public ContactMiriam Wiestler

Medizinische Hochschule Hannover

wiestler.miriam@mh-hannover.de0511-532-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026