Effects of negative mood and systemic low-grade inflammation on visceral pain perception and visceral pain processing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016994

Enrollment

Registered

2019-03-26

Start date

2019-03-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Healthy volunteers R10.4

Interventions

Group 1: Single injection of low-dose endotoxin (E. coli, O113:H10

i.v., 0.4 ng/kg body weight) to induce systemic low-grade inflammation. Dependent variables will be assessed before (baseline) and up to 6 hours post-injection. Group 2: Single injection of placebo (s

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy male and female (using contraceptives) volunteers, aged 18-50, right-handed

Exclusion criteria

Exclusion criteria: Acute and chronic conditions, intake of medication (excluding oral contraceptives). Smoking, body mass index > 30 oder < 18 kg/m². Anorectal tissue damage and evidence of structural brain abnormality upon structural MRI scan. Additional MRI-specific exclusion criteria included phobic anxiety, claustrophobia and ferromagnetic implantations. Psychiatric conditions (anxtiety, depression) based on DSM-V criteria, assessed with validated screening instruments.

Design outcomes

Primary

Measure	Time frame
Assessment of sensory-discriminative, affective, and cognitive components of pain, as well as of psychological states (mood) using visual analogue scales (VAS). Assessment of neural (blood-oxygen level-dependent, BOLD) responses to visceral stimuli and to mood-related cues using fMRI. Outcome variables will be assessed 2-4h post-injection of LPS (lipopolysaccharide) or placebo, respectively.	—

Secondary

Measure	Time frame
Repeated measures (baseline, as well as 1h, 2h, 3h, 4h, 6h und 24h after injection of LPS/placebo): Plasma TNF-a, IL-6, IL-10, cortisol. Blood pressure, heart rate, body temperature. Psychological states (mood, anxiety) and bodily symptoms using validated questionnaires (MDBF; STADI; STAI-S; GASE). Before the first study day, a questionnaire battery will be filled in to assess the health status and psychological traits (including symptoms of depression and anxiety, pain-related cognitions, coping, personality traits).	—

Measure

Time frame

Repeated measures (baseline, as well as 1h, 2h, 3h, 4h, 6h und 24h after injection of LPS/placebo): Plasma TNF-a, IL-6, IL-10, cortisol. Blood pressure, heart rate, body temperature. Psychological states (mood, anxiety) and bodily symptoms using validated questionnaires (MDBF; STADI; STAI-S; GASE). Before the first study day, a questionnaire battery will be filled in to assess the health status and psychological traits (including symptoms of depression and anxiety, pain-related cognitions, coping, personality traits).

—

Countries

Germany

Contacts

Public ContactLisa Brotte

Universitätsklinikum Essen, Institut für Medizinische Psychologie und Verhaltensimmunbiologie

lisa.brotte@uk-essen.de0201/723-4494

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026