NCT06522750Recruiting
Periodic Fasting for Treatment of Long Covid in Adults: a Pilot Study
Pilot Study on the Feasibility of an RCT: Evaluating Periodic Fasting as a Treatment Strategy for Long Covid in Adults
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Background: Long COVID, characterized by persistent symptoms following acute COVID-19 infection, has emerged as a significant public health concern. Symptoms range from fatigue, cognitive impairments, to respiratory difficulties, affecting patients\' quality of life. Dietary interventions, particularly fasting, have historically been used to modulate immune responses and improve health outcomes in various conditions. The Buchinger-Wilhelmi method represents a structured and medically supervised fasting approach. Given the inflammatory nature of long COVID, fasting may offer therapeutic benefits by modulating the immune response, enhancing cellular repair mechanisms, and resetting metabolic processes. Objectives: This clinical trial aims to assess the feasibility of a 7-day ambulatory fasting intervention using the Buchinger-Wilhelmi method on long COVID patients as primary objective. As secondary objectives, the study will investigate the potential beneficial impact of fasting on clinical, biological, and psychological parameters over a period of 4 weeks, offering insights into potential therapeutic avenues for long COVID management. Study timeline: The research will span a period of 4 weeks Study population: This study aims to recruit around 20 participants, who will all receive a fasting intervention using the Buchinger-Wilhelmi method. Biological sample and data collection: Participants will undergo various data and sample collection procedures, including blood draws of up to 90 42 ml per visit, collection of peripheral mononuclear cells, stool samples, and completion of questionnaires in a smartphone-based Application (MyCap). Sample analysis: The collected samples will be subjected to a range of analyses, including the assessment of serological markers for routine blood chemistry, evaluation of inflammation markers, and examination of stool samples.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 May 2024
- Start date
- 19 Feb 2025
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- University of Luxembourg
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06522750
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 19 Feb 2025 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anti-psychotic drugs
- Antibiotic use during the previous 12 months
- Start of novel drug therapy
Other illness
- Current underweight condition (body mass index less than 18.5 kg/m2) or weight loss exceeding 3 kg within the last month or 5 kg within the last three months.
- Existing / current eating disorder within the past five years (e.g., anorexia, bulimia).
- Psychiatric condition that limits understanding of the examination protocol (unable to consent)
- Diagnosis of chronic inflammatory bowel diseases, celiac disease or colorectal cancer according to the guidelines of the German Society of Gastroenterology
Lab values
- Severe internal disease (e.g. kidney deficiency with creatinine \> 2mg/dl), chronic inflammatory illness other than LCS
- Contraindication for additional blood draws (e.g. hemoglobin \<10)
Other
- Participation in another intervention study.
- Existing vegan diet or fasting during the last six months
- Pregnancy or breastfeeding status.
- Presence or suspicion of pre-existing ME/CFS or early autonomous dysfunction
Who the study is looking for
- Age 18-64
- Diagnosis Long Covid Syndrome (post-acute COVID-19 symptoms persisting ≥12 weeks)
- Normal body Mass Index (18.5 to 25 kg/m2)
- Marginal Iron status ( PF\< 25 ng/ml)
- Able to communicate in and comprehend English and/or German and/or French language
- Present written / signed declaration of consent
- Ability to understand the patient information and willingness to sign the consent form
- Consent to specimen collection and specimen use
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rehaklinik CHNP Coordinator of this site? Confirm its status | Ettelbruck | Luxembourg | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.