Evaluating the effects of gut microbiota and sleep on pain sensitivity
Pain, Sleep and Gut Microbiota
This study is testing how gut health and sleep quality affect how sensitive people are to pain in healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Université Catholique de Louvain Academic / other |
| Locations | 1 site (Woluwe-Saint-Lambert) |
| Trial ID | NCT05494983 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how the composition of gut microbiota and sleep quality affect the susceptibility to both peripheral and central sensitization of pain pathways in healthy volunteers. Participants will undergo two experimental sessions where they will be exposed to capsaicin to induce peripheral sensitization and high-frequency electrical stimulation to assess central sensitization. The study will measure the resulting neurogenic inflammation and pain sensitivity using advanced imaging techniques. The findings could provide insights into the relationship between gut health, sleep, and pain perception.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 who can understand French and provide informed consent.
Not a fit: Patients with recent use of antibiotics, certain medical conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for managing pain by targeting gut microbiota and sleep quality.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated a connection between gut microbiota and pain sensitivity, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 18 and 65 years * Ability to provide written informed consent * Understanding French Exclusion Criteria: * Current or recent (\< 2 months) use of antibiotics, probiotics, fiber supplements or any other molecule that modifies intestinal transit. * Current or recent (\< 1 month) use of non-steroidal anti-inflammatory drugs and glucocorticoids * Not willing or able to abstain from acute alcohol intoxication from 7 days prior to each of the two study sessions. * Consumption of alcohol 24 hours prior to each of the two study sessions. * Consumption of hypnotics, centrally-acting analgesics or psychotropic drugs. * Obesity: body mass index \> 30 kg.m-2 * Pregnancy and breast-feeding * Diabetes * Cancer * History of inflammatory bowel disease * History of weight-loss surgery (e.g., gastric bypass, gastric band) * History of autoimmune disease (e.g., lupus, rheumatoid arthritis) * Evidence for any other clinically significant disease on direct questioning. * Being a volleyball player due to risk of modified sensitivity of the volar forearm skin. * Any implanted medical device such as cardiac pacemakers, cochlear implants and medication pumps. * Dermatological condition affecting the skin of the volar forearms. * History of an allergy to chili peppers/capsaicin. * Any other reason to exclude the subject according to judgment by the investigator.
Where this trial is running
Woluwe-Saint-Lambert
- UCLouvain, IONS — Woluwe-Saint-Lambert, Belgium (Recruiting)
Study contacts
- Principal investigator: André Mouraux, MD, PhD — UCLouvain, IONS
- Study coordinator: Gwenaëlle Mievis, PhD Student
- Email: gwenaelle.mievis@uclouvain.be
- Phone: +32488451915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.