Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

2. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

75

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Nahrungsergänzungsmittel: 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.
Placebo-Komparator: 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.
Nahrungsergänzungsmittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Abundance of butyrate-producing gut bacteria
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in body weight
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in the abundance of butyrate-producing gut bacteria
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at baseline
Measurement of body height (cm)
at baseline
Changes in resting blood pressure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: baseline
status: never, former, current
baseline
Confounding medical events and medication
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Buchinger Wilhelmi Development & Holding GmbH

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

28. Februar 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

9. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • F-2026-010

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren