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

2 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

75

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Integratore alimentare: 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.
Comparatore 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.
Integratore alimentare: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Abundance of butyrate-producing gut bacteria
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in body weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the abundance of butyrate-producing gut bacteria
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: at baseline
Measurement of body height (cm)
at baseline
Changes in resting blood pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline
status: never, former, current
baseline
Confounding medical events and medication
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Buchinger Wilhelmi Development & Holding GmbH

Collaboratori

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

Investigatori

  • Investigatore principale: Andrea Siegler, Dr. med., Buchinger Wilhelmi Development & Holding

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

28 febbraio 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • F-2026-010

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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