NCT05494983

Pain, Sleep and Gut Microbiota

Status unknown NA Last updated 30 January 2024

What this trial tests

NA trial testing Screening visit in Sensitization, Central in 140 participants. Status unknown.

Timeline

4 July 2022

Primary endpoint
30 June 2025

4 January 2026

Quick facts

Lead sponsor	Université Catholique de Louvain
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	140
Start date	4 July 2022
Primary completion	30 June 2025
Estimated completion	4 January 2026
Sites	1 location across Belgium

Drugs / interventions tested

• Screening visit
• Peripheral sensitization session
• Central sensitization session

Conditions studied

• Sensitization, Central — all drugs for Sensitization, Central →
• Peripheral Sensitization — all drugs for Peripheral Sensitization →
• Gut Microbiota — all drugs for Gut Microbiota →
• Sleep Quality — all drugs for Sleep Quality →

Sponsor

Université Catholique de Louvain — full company profile →

Who can join

Adults 18 to 65, any sex, with Sensitization, Central or Peripheral Sensitization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study in healthy volunteers is to evaluate whether the composition of the gut microbiota and sleep quality influence the susceptibility to develop peripheral and central sensitization of pain pathways.

In two different experimental sessions, the following factors will be tested: the influence of the composition of the gut microbiota on the susceptibility to develop peripheral sensitization of nociceptors, and the susceptibility to develop central sensitization of pain pathways. To assess susceptibility to peripheral sensitization, a solution of capsaicin (the active component of chili pepper) will be applied to the skin to induce neurogenic inflammation produced by the release of substances from nociceptors at the peripheral level. This neurogenic inflammation is characterized by a transient redness of the skin that will be measured with an infrared camera. To evaluate the susceptibility to sensitization at the central level, a high frequency electrical stimulation will be applied to the skin. This stimulation induces an increase in sensitivity to mechanical stimulation secondary to central sensitization. The intensity, extent and duration of this mechanical hyperalgesia will therefore be used as a measure of susceptibility to central sensitization.

A stool sample and a blood sample will be taken. These samples will be used to characterize the composition of the intestinal microbiota, as well as the metabolites produced by this microbiota. These analyses will allow a comparison of the composition of the microbiota and the metabolites in subjects with a tendency to develop low vs. high sensitization at the peripheral and central levels.

Similarly, sleep quality and average sleep duration will be assessed using questionnaires and a measurement of the participant's activity using a wrist movement sensitive bracelet. This information will be used to assess whether some of the interindividual variability in developing peripheral or central sensitization might be related to differences in sleep quality.

Finally, systemic inflammation could be a factor modulated by sleep and gut microbiota, influencing pain perception and susceptibility to sensitization. For this reason, systemic pro- and anti-inflammatory cytokines will be measured in the blood sample.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.