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Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits (CoFFIe)

2 juillet 2026 mis à jour par: Buchinger Wilhelmi Development & Holding GmbH

This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health. Whether long-term fasting and dietary fibre interventions could be combined to achieve synergistic improvements in host metabolic health is however unknown. The goal is to provide a proof of concept in a human trial that supplementing 10±4 days fasting with dietary fibre synergistically improves metabolic outcomes via gut microbiome-mediated effects. To assess this, we aim to analyse gut microbiome changes, functional outputs, and key metabolic markers such as butyrate production, glycaemic control and ketosis.

The randomised controlled trial includes 75 participants and has two arms: one involving fasting with fibre supplementation (n = 50) and one involving fasting without fibre supplementation (n = 25). All participants will undergo a fasting period of 10±4 days according to the Buchinger Wilhelmi protocol, followed by a stepwise reintroduction of food of up to 4 days. As dietary fibre we will use maize-derived resistant starch type IV, selected based on its ability to stimulate beneficial gut microbes like Oscillibacter and corn starch as placebo. Two main visits will be conducted: before and at the end of the fasting period. During these visits, blood and stool samples will be collected, and questionnaires will be completed. Additionally, daily measurements of anthropometric parameters and well-being will be recorded. Stool samples will also be collected one month afterwards as a follow-up. Participants' metabolic health will be evaluated through various clinical parameters (e.g., body measurements, blood pressure, glycaemic control, ketones, well-being). Additionally, multi-omics data, including metagenomics and metabolomics, will provide insight into the composition of the microbiome, as well as its outputs and functions. Furthermore, the effects of fasting on extracellular vesicles in blood will be explored.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

75

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Men and women
  • Age: 18-65 years old
  • Fasting for 10±4 days at the Buchinger Wilhelmi clinic in Überlingen
  • BMI ≥ 25 kg/m²
  • Signed informed consent

Exclusion Criteria:

  • intake of antibiotics up to 2 months prior the study
  • regular intake of pre-, post- and probiotics up to 2 months prior the study
  • diagnosed Crohn's disease, Ulcerative colitis, IBD, coeliac disease
  • medicated high blood pressure
  • diagnosed diabetes mellitus type I
  • medicated diabetes mellitus type II
  • diagnosed kidney stone
  • active malignant disease
  • known substance addiction
  • pregnancy or breastfeeding
  • diagnosed with cachexia, anorexia nervosa, advanced kidney, liver or cerebrovascular insufficiency
  • inability to sign the informed consent
  • participation in another study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Fibre Arm
Participants (n=50) undergo a 10±4-day fasting period according to the Buchinger Wilhelmi fasting programme and receive maize-derived resistant starch type IV at a total dose of 20 g per day. The powder is blended into a carbohydrate-free electrolyte powder, divided into two equal daily doses, diluted in approximately 0.2 litres of water, and taken orally in the morning and at dinnertime throughout the fasting period. The fasting period is followed by a structured food reintroduction period according to the standard procedure of the Buchinger Wilhelmi Clinic. All other aspects of the intervention, including the fasting and nutritional protocol, clinical supervision, and study assessments, are identical to the control arm.
Complément alimentaire: Fibre Arm
10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 20 g/day of maize-derived resistant starch type IV.
Comparateur placebo: Control Arm
Participants (n=25) undergo a 10±4-day fasting period according to the Buchinger Wilhelmi fasting programme and receive corn starch placebo at a total dose of 1.2 g per day. The powder is blended into a carbohydrate-free electrolyte powder, divided into two equal daily doses, diluted in approximately 0.2 litres of water, and taken orally in the morning and at dinnertime throughout the fasting period. The fasting period is followed by a structured food reintroduction period according to the standard procedure of the Buchinger Wilhelmi Clinic. All other aspects of the intervention, including the fasting and nutritional protocol, clinical supervision, and study assessments, are identical to the intervention arm.
Complément alimentaire: Control Arm
10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 1.2 g/day of corn starch placebo.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Abundance of butyrate-producing gut bacteria
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in the relative abundance of butyrate-producing gut bacteria assessed by metagenomic profiling of faecal samples.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in fasting venous plasma glucose
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Fasting venous plasma glucose concentration measured by clinical laboratory analysis (mmol/L).
Baseline (T0) and end of the 10±4-day fasting period (T1)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in body weight
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Body weight (kg) measured as part of the clinical health assessment.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in body mass index
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Body mass index calculated from measured body weight and height (kg/m²).
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in waist circumference
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Waist circumference (cm) measured as part of the clinical health assessment.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in HbA1c
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
HbA1c (mmol/mol) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in HOMA index
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
HOMA index calculated from fasting plasma glucose and fasting insulin concentrations.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in fasting venous insulin
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Fasting venous insulin concentration (pmol/L) measured by clinical laboratory analysis.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in glycaemic control assessed by continuous glucose monitoring
Délai: From Day 1 through Day 14
Glycaemic control assessed by blinded continuous glucose monitoring using the FreeStyle Libre 3 system, with glucose values recorded at 1-minute intervals (mmol/L).
From Day 1 through Day 14

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in the abundance of butyrate-producing gut bacteria
Délai: Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
Exploratory assessment of the change in the abundance of butyrate-producing gut bacteria, derived from metagenomic profiling. Additional unscheduled samples may be collected during fasting if spontaneous bowel movements occur.
Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
Change in body weight
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Exploratory assessment of change in body weight (kg)
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Change in body mass index
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Exploratory assessment of change in body mass index (kg/m²).
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Change in glycaemic control assessed by continuous glucose monitoring
Délai: From day 15 through day 28
Exploratory assessment of change in glycaemic control during the post-fasting follow-up period, assessed by open-label continuous glucose monitoring.
From day 15 through day 28
Change in gut microbiome composition and functional output
Délai: Baseline, end of the 10±4-day fasting period, and 1 month after fasting
Change in gut microbiome composition and functional output from baseline and the end of the fasting period to the one-month follow-up, assessed by metagenomics, metatranscriptomics, metabolomics, and short-chain fatty acid analysis. Additional unscheduled samples may be collected during fasting if spontaneous bowel movements occur
Baseline, end of the 10±4-day fasting period, and 1 month after fasting
Height
Délai: at baseline
Measurement of body height (cm)
at baseline
Changes in resting blood pressure
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Resting systolic blood pressure (mmHg) and resting diastolic blood pressure (mmHg) measured as part of the clinical health assessment and as self-measurement at follow-up.
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Change in heart rate
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Heart rate (beats/min) measured as part of the clinical health assessment and as self-measurement at follow-up.
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, and 1 month after fasting (T2)
Change in leucocyte count
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in leucocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in erythrocyte count
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in erythrocyte count (10¹²/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in haemoglobin concentration
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in haemoglobin concentration (g/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in haematocrit
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in haematocrit levels (L/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in mean corpuscular volume (MCV)
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in mean corpuscular volume (fL) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in mean corpuscular haemoglobin (MCH)
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in mean corpuscular haemoglobin (pg) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in mean corpuscular haemoglobin concentration (MCHC)
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in mean corpuscular haemoglobin concentration (g/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in thrombocyte count
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in thrombocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in lymphocyte count
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in lymphocyte count (10⁹/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in international normalized ratio (INR)
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in international normalized ratio (dimensionless) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in Quick value
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in Quick value (%) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in partial thromboplastin time (PTT)
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in partial thromboplastin time (seconds) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Changes in liver parameters
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Liver-related parameters measured by clinical laboratory analysis of venous blood: aspartate aminotransferase (U/L), alanine aminotransferase (U/L), gamma-glutamyl transferase (U/L), and alkaline phosphatase (U/L).
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in uric acid
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in uric acid levels (µmol/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in urea
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in urea levels (mmol/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in creatinine
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in creatinine levels (µmol/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in estimated glomerular filtration rate (eGFR)
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in estimated glomerular filtration rate (mL/min/1.73 m²) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Changes in lipid parameters
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Lipid parameters measured by clinical laboratory analysis of venous blood: total cholesterol (mmol/L), triglycerides (mmol/L), high-density lipoprotein cholesterol (mmol/L), low-density lipoprotein cholesterol (mmol/L), and non-high-density lipoprotein cholesterol (mmol/L).
Baseline (T0) and end of the 10±4-day fasting period (T1)
Changes in serum electrolyte concentrations
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Electrolyte concentrations measured by clinical laboratory analysis of venous blood: sodium (mmol/L), potassium (mmol/L), calcium (mmol/L), and magnesium (mmol/L).
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in high-sensitivity C-reactive protein
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
High-sensitivity C-reactive protein concentration (mg/L) measured by clinical laboratory analysis of venous blood.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in extracellular vesicle size
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in extracellular vesicle size (nm) derived from the analysis of venous blood samples.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in extracellular vesicle concentration
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in extracellular vesicle concentration (particles/mL) derived from the analysis of venous blood samples.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in extracellular vesicle cargo profile
Délai: Baseline (T0) and end of the 10±4-day fasting period (T1)
Change in extracellular vesicle cargo profile derived from the analysis of venous blood samples.
Baseline (T0) and end of the 10±4-day fasting period (T1)
Changes in urinary acetoacetic acid
Délai: Baseline (T0) and daily during the 10±4-day fasting period and food reintroduction period
Acetoacetic acid measured in urine as a biomarker of ketosis.
Baseline (T0) and daily during the 10±4-day fasting period and food reintroduction period
Change in WHO-5 well-being index
Délai: Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
Change in WHO-5 (score: 0-100)
Baseline (T0), end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
Changes in self-reported gut health and symptoms
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
Questionnaire-based assessment of gastrointestinal and systemic symptoms using a 0-to-10 numerical rating scale (where 0 = none/not full and 10 = very strong/very full). Symptoms assessed include hunger, bloating/fullness, flatulence, abdominal discomfort/pain, nausea, heartburn, acid regurgitation, cravings, fatigue, headache, and sleep disturbances.
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period, end of the 10±4-day fasting period (T1), and 1 month after fasting (T2)
Change in self-reported physical activity
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
Change in physical activity level (hours/day) assessed by online questionnaires.
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
Change in self-reported physical activity
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
Change in physical activity level (VAS 0-10) assessed by online questionnaires.
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
Change in self-reported well-being
Délai: Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
Change in self-reported physical and emotional well-being (VAS 0-10) as well as energy level (VAS 0-10) assessed by online questionnaires.
Baseline (T0), daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction), and 1 month after fasting (T2)
Occurrence of adverse effects
Délai: Through study completion, an average of 7 weeks
Number and characteristics of possible adverse effects assessed from participant reports and documentation by the study physician, including seriousness and possible relationship to the study intervention.
Through study completion, an average of 7 weeks
Smoking behavior
Délai: baseline
status: never, former, current
baseline
Confounding medical events and medication
Délai: Baseline (T0) and 1 month after fasting (T2)
Number of participants reporting concomitant medication use, supplement intake, or medical interventions (including antibiotics, prebiotics, probiotics, postbiotics, dietary supplements, hormonal therapies, surgeries, gastrointestinal endoscopies, or hospitalizations).
Baseline (T0) and 1 month after fasting (T2)
Dietary patterns
Délai: Baseline (T0) and 1 month after fasting (T2)
Number of participants practicing specific dietary patterns (including omnivorous, flexitarian, pescetarian, vegetarian, vegan, or other specific diets like ketogenic).
Baseline (T0) and 1 month after fasting (T2)
Change in intake of specific food categories
Délai: Baseline (T0) and 1 month after fasting (T2)
Questionnaire-based assessment of dietary fiber and fermented food intake (measured in portions per day or week) across specific food categories, including fruit, vegetables, bread and grain products, nuts and seeds, legumes, and fermented foods.
Baseline (T0) and 1 month after fasting (T2)
Change in alcohol consumption
Délai: Baseline (T0) and 1 month after fasting (T2)
Questionnaire-based assessment of average weekly alcohol consumption (measured in standard glasses per week) across specific beverage types, including wine, beer, and spirits.
Baseline (T0) and 1 month after fasting (T2)
Change in stool consistency
Délai: Baseline (T0) and 1 month after fasting (T2)
Change in usual stool consistency measured by the Bristol Stool Chart (Type 1 to Type 7; coded as an ordinal category).
Baseline (T0) and 1 month after fasting (T2)
Change in bowel movement frequency
Délai: Baseline (T0) and 1 month after fasting (T2)
Change in typical bowel movement frequency categorized into four ordinal levels (from 1-2 times per week up to more than 3 times per day)
Baseline (T0) and 1 month after fasting (T2)
Change in general gut health rating
Délai: Baseline (T0) and 1 month after fasting (T2)
Change in subjective general gut health rated on a 0-to-10 numerical rating scale (where 0 = very poor and 10 = excellent).
Baseline (T0) and 1 month after fasting (T2)
Initial laxative methods
Délai: End of the 10±4-day fasting period (T1)
Number of participants utilizing specific laxative methods at the beginning of the fasting period (including Glauber's salt, Laxoberal, enemas, other laxatives, or no laxative use).
End of the 10±4-day fasting period (T1)
Palatability of the dietary fiber supplement
Délai: End of the 10±4-day fasting period (T1)
Subjective taste rating of the dietary fiber supplement measured on a 7-point Likert scale (from "not at all" to "very good").
End of the 10±4-day fasting period (T1)
Perceived change in digestion during fiber supplementation
Délai: End of the 10±4-day fasting period (T1)
Participant-reported change in digestion during the supplementation period, measured on a 7-point Likert scale (from "very negative" to "very positive").
End of the 10±4-day fasting period (T1)
Tolerability of the dietary fiber supplement
Délai: End of the 10±4-day fasting period (T1)
Subjective tolerability rating of the dietary fiber supplement measured on a 7-point Likert scale (from "very poorly" to "very well").
End of the 10±4-day fasting period (T1)
Intervention compliance
Délai: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
Compliance with the dietary fiber supplementation protocol, calculated as the percentage of prescribed doses successfully consumed (both morning and evening doses) during the fasting and food reintroduction periods, as verified by participant daily logs.
Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
Utilization of optional supplements during fasting
Délai: Daily during the 10±4-day fasting period (Day 1 through end of fasting (T1))
Tracking the consumption of optional dietary additions permitted within the fasting protocol. This includes the number of participants choosing to consume midday juice, honey, or other additions (such as yogurt, Kousmine cream, oatmeal, or carrot juice).
Daily during the 10±4-day fasting period (Day 1 through end of fasting (T1))
Daily bowel movement occurrence and induction method
Délai: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
Number of participants reporting a bowel movement each day, categorized by the method of clearance (none, spontaneous, induced by enema, induced by colon hydrotherapy, or induced by laxatives).
Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
Daily spontaneous stool consistency
Délai: Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
Daily assessment of stool consistency for participants with spontaneous bowel movements, scored using the Bristol Stool Chart (Type 1 to Type 7; analyzed as daily ordinal categories or mean scores).
Daily during the 10±4-day fasting period and food reintroduction period (Day 1 through end of reintroduction)
Daily fluid intake
Délai: Daily during the 10±4-day fasting period and food reintroduction period
Daily self-reported volume of water or herbal tea consumed by participants, measured in liters (L).
Daily during the 10±4-day fasting period and food reintroduction period

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Buchinger Wilhelmi Development & Holding GmbH

Collaborateurs

Buchinger Wilhelmi Clinic, 88662 Überlingen, Germany
King's College London, Faculty of Life Sciences & Medicine, Department of Nutritional Sciences, London, United Kingdom
Leiden University Medical Center, Department Leiden University Center for Infectious Diseases, 2333ZA, Leiden, Netherlands
TNO, Department Microbiology & Systems Biology, 2333 BE Leiden, Netherlands
Università degli Studi di Milano, Department of Pharmacological and Biomolecular Sciences Rodolfo Paoletti, Milan, Italy
Department of Cardio-Thoracic-Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Les enquêteurs

  • Chercheur principal: Andrea Siegler, Dr. med., Buchinger Wilhelmi Development & Holding

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

28 février 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

24 juin 2026

Première soumission répondant aux critères de contrôle qualité

2 juillet 2026

Première publication (Réel)

9 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • F-2026-010

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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