Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: from risk factors to modification

Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: a 3-arm randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30800023

Enrollment

234

Registered

2021-07-21

Start date

2022-04-04

Completion date

Unknown

Last updated

2025-03-31

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

Conditions

Gastrointestinal symptoms in patients with irritable bowel syndrome or ulcerative colitis Digestive System

Interventions

Current intervention as of 26/11/2021: We will use the design of a three-arm randomised-controlled trial (RCT). A fixed randomisation schedule, stratified by diagnostic group and sex, will be programm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of ulcerative colitis (UC) or irritable bowel syndrome (IBS; Rome IV); 2. at least moderate gastrointestinal symptoms according to the Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS = 175); 3. UC/IBS treatment according to current German AWMF guidelines; 4. informed consent.

Exclusion criteria

Exclusion criteria: 1. Necessity of acute emergency treatment 2. Acute suicidality 3. Psychotherapeutic treatment in the past 3 months 4. Insufficient German language skills

Design outcomes

Primary

Measure	Time frame
Gastrointestinal symptom severity assessed using the Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS) at baseline, after 6 weeks, after 3 months (post-interventional follow-up), after 6 and 12 months	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 26/11/2021: 1. Total somatic symptom severity measured using the Patient Health Questinnaire-15 (PHQ-15) at baseline, 6 weeks, 3 months, 6 months, and 12 months 2. Illness-related anxiety measured using the Somatic Symptom Disorder – B-Criteria Scale (SSD-12) at baseline, 6 weeks, 3 months, 6 months. and 12 months 3. Illness-related worries measured using the Whitley Index – 7 item scale (WI-7) at baseline, 6 weeks, 3 months, 6 months. and 12 months 4. Expectations of symptom severity measured using a Numeric Rating Scale (NRS) at baseline, 6 weeks, 3 months, 6 months, and 12 months 5. Expectations of coping with symptoms measured using a Numeric Rating Scale (NRS) at baseline, 6 weeks, 3 months, 6 months, and 12 months 6. Expectations of impairment due to somatic symptoms measured using a Numeric Rating Scale (NRS) at baseline, 6 weeks, 3 months, 6 months, and 12 months 7. Treatment expectations measured using the Treatment Expectation Questionnaire (TEX-Q) at baseline, 6 weeks, 3 months, 6 months, and 12 months 8. Disease activity measured using the Simple Clinical Colitis Activity Index (SCCAI) at baseline, 6 weeks, 3 months, 6 months, and 12 months 9. Time since last treatment measured using a single question at baseline, 6 weeks, 3 months, 6 months, and 12 months 10. Utilisation of medical treatment measured using gastrointestinal questions at baseline, 6 weeks, 3 months, 6 months, and 12 months 11. Adverse effects measured using a single question at baseline, 6 weeks, 3 months, 6 months, and 12 months 12. Evaluation of the interventions measured using Numeric Rating Scales (NRS) at 3 months 13. Systemic inflammation measured using C-reactive protein (CRP), interleukin 6 (IL-6), and tumour necrosis factor (TNF) at baseline and 3 months 14. Intestinal inflammation measured using faecal calprotectin at baseline and 3 months 15. Risk factors of somatic symptom persistence measured using the SOMACROSS research unit’s core i	—

Measure

Time frame

Current secondary outcome measures as of 26/11/2021: 1. Total somatic symptom severity measured using the Patient Health Questinnaire-15 (PHQ-15) at baseline, 6 weeks, 3 months, 6 months, and 12 months 2. Illness-related anxiety measured using the Somatic Symptom Disorder – B-Criteria Scale (SSD-12) at baseline, 6 weeks, 3 months, 6 months. and 12 months 3. Illness-related worries measured using the Whitley Index – 7 item scale (WI-7) at baseline, 6 weeks, 3 months, 6 months. and 12 months 4. Expectations of symptom severity measured using a Numeric Rating Scale (NRS) at baseline, 6 weeks, 3 months, 6 months, and 12 months 5. Expectations of coping with symptoms measured using a Numeric Rating Scale (NRS) at baseline, 6 weeks, 3 months, 6 months, and 12 months 6. Expectations of impairment due to somatic symptoms measured using a Numeric Rating Scale (NRS) at baseline, 6 weeks, 3 months, 6 months, and 12 months 7. Treatment expectations measured using the Treatment Expectation Questionnaire (TEX-Q) at baseline, 6 weeks, 3 months, 6 months, and 12 months 8. Disease activity measured using the Simple Clinical Colitis Activity Index (SCCAI) at baseline, 6 weeks, 3 months, 6 months, and 12 months 9. Time since last treatment measured using a single question at baseline, 6 weeks, 3 months, 6 months, and 12 months 10. Utilisation of medical treatment measured using gastrointestinal questions at baseline, 6 weeks, 3 months, 6 months, and 12 months 11. Adverse effects measured using a single question at baseline, 6 weeks, 3 months, 6 months, and 12 months 12. Evaluation of the interventions measured using Numeric Rating Scales (NRS) at 3 months 13. Systemic inflammation measured using C-reactive protein (CRP), interleukin 6 (IL-6), and tumour necrosis factor (TNF) at baseline and 3 months 14. Intestinal inflammation measured using faecal calprotectin at baseline and 3 months 15. Risk factors of somatic symptom persistence measured using the SOMACROSS research unit’s core i

—

Countries

Germany

Contacts

Public ContactBernd Löwe

b.loewe@uke.de+49 40 7410 59733

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026