Oral and Gut Microbiota Changes During Long-term Fasting in Humans (OralFast)

January 12, 2023 updated by: Françoise Wilhelmi de Toledo, Buchinger Wilhelmi Development & Holding GmbH
The aim of this longitudinal trial is to investigate the effects of a 10±3-day fasting period in 30 subjects. Changes in the oral and gut microbiota, halitosis, as well as inflammatory and antioxidative parameters and biomarkers of sulfur metabolism will be analysed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fasting has been linked with changes in gut microbiota as part of the physiological adaptation. Furthermore, associations have been described between oral disease and nutrition (diet rich in carbohydrates). The aim of the present longitudinal clinical study is to explore the effect of a 10±3-day fasting period on the oral and gut microbiota. 30 systemically healthy subjects attending the Buchinger Wilhelmi Clinics for fasting, will participate. Changes in oral microbiota will be assessed in plaque and saliva samples and a number of inflammatory markers will be analyzed in Gingival Crevicular fluid (GCF) and blood obtained before, during and after the fasting period. The changes in the oral microbiota will be associated to the composition of the gut microbiota. Changes in periodontal parameters and halitosis related to the fasting period will be further evaluated. Given the known association between sulfur metabolism and the redox status, parameters from the antioxidant status and oxidative damages will also be assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Überlingen, Germany, 88662
        • Buchinger Wilhelmi Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both subjects with periodontitis and healthy periodontium will be included.
  • Signed informed consent

Exclusion Criteria:

  • Not able to sign the informed consent
  • diagnosticated with cachexia, anorexia, nervosa, advanced kidney, liver or cerebrovascular insufficiency
  • Smoking
  • the intake of antibiotics within the last 8 weeks, as well as the intake of probiotics within the last 4 weeks
  • periodontal treatment in the last 6 months
  • chronic manifest psychical and psychiatric diseases
  • participation in another study
  • pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Long-term fasting
Long-term fasting according to the Buchinger Wilhelmi fasting program.
Procedure: Long-term fasting
The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in halitosis
Time Frame: daily from baseline to the 3rd day of food reintroduction
Concentration of volatile sulfide compounds (hydrogen sulfide, methylmercaptan and dimethyl sulphide) using the OralChrome devise
daily from baseline to the 3rd day of food reintroduction
Changes in microbiota compositions of subgingival microbial and plaque sampling
Time Frame: Baseline, fasting day 10, food reintroduction day 3
Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas (Pg), Tannerella forsythia (Tf), Treponema denticola (Td), Parvimonas micra (Pm) and Prevotella intermedia (Pi) analysed by RT-q-PCR
Baseline, fasting day 10, food reintroduction day 3
Changes in microbiota composition in saliva
Time Frame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
16 rRNA gene amplicon sequencing
Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
Changes in microbiota composition in faeces
Time Frame: Baseline, first spontaneous stool after food reintroduction (up to day 3), 1 and 3 months afterwards
16 rRNA gene amplicon sequencing
Baseline, first spontaneous stool after food reintroduction (up to day 3), 1 and 3 months afterwards
Changes in total antioxidant capacity (TAC)
Time Frame: Baseline, fasting day 3, 5, 10
(mmol DPPH/L)
Baseline, fasting day 3, 5, 10
Changes in hydrogen sulfide production capacity
Time Frame: at the beginning and the end of fasting, on day 3 and 5, as well as at the food reintroduction
measured in serum and urine using the lead acetate assay
at the beginning and the end of fasting, on day 3 and 5, as well as at the food reintroduction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in glutathione (GSH)
Time Frame: Baseline, fasting day 3, 5, 10
(µmol/g Hb)
Baseline, fasting day 3, 5, 10
Changes in thiobarbituric acid reactive substances (TBARS)
Time Frame: Baseline, fasting day 3, 5, 10
(µmol/L)
Baseline, fasting day 3, 5, 10
Changes in malondialdehyde (MDA)
Time Frame: Baseline, fasting day 3, 5, 10
nM/L
Baseline, fasting day 3, 5, 10
Changes in protein carbonyls
Time Frame: Baseline, fasting day 3, 5, 10
(nmol/mg protein)
Baseline, fasting day 3, 5, 10
Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase
Time Frame: Baseline, fasting day 3, 5, 10
(µL)
Baseline, fasting day 3, 5, 10
Changes in glutathione reductase (GR) activity
Time Frame: Baseline, fasting day 3, 5, 10
(U/g Hb)
Baseline, fasting day 3, 5, 10
Changes in glutathione peroxidase (GPx) activity
Time Frame: Baseline, fasting day 3, 5, 10
(U/g Hb)
Baseline, fasting day 3, 5, 10
Changes in peroxiredoxin activity
Time Frame: Baseline, fasting day 3, 5, 10
(U/g Hb)
Baseline, fasting day 3, 5, 10
Changes in catalase (CAT) activity
Time Frame: Baseline, fasting day 3, 5, 10
(U/mg Hb)
Baseline, fasting day 3, 5, 10
Changes in superoxide dismutase (SOD) activity
Time Frame: Baseline, fasting day 3, 5, 10
(U/g Hb)
Baseline, fasting day 3, 5, 10
Changes in hydroxyl radical scavenging
Time Frame: Baseline, fasting day 3, 5, 10
(mmol deoxyribose/ml)
Baseline, fasting day 3, 5, 10
Changes in superoxydradical scavenging
Time Frame: Baseline, fasting day 3, 5, 10
(mmol NBT/L plasma)
Baseline, fasting day 3, 5, 10
Changes in ABTS scavenging
Time Frame: Baseline, fasting day 3, 5, 10
(mmol/L)
Baseline, fasting day 3, 5, 10
Changes in reducing power
Time Frame: Baseline, fasting day 3, 5, 10
(mmol/L plasma)
Baseline, fasting day 3, 5, 10
Changes in thiosulfate
Time Frame: Baseline, fasting day 10, food reintroduction day 3
measured using the monobromobimane method using HPLC and LC-MS/MS
Baseline, fasting day 10, food reintroduction day 3
Changes in persulfidation
Time Frame: Baseline, fasting day 10, food reintroduction day 3
persulfidation in serum and urine
Baseline, fasting day 10, food reintroduction day 3
Changes in cystein
Time Frame: Baseline, fasting day 10, food reintroduction day 3
using the S-sulfocysteine (SSC) method which is a HPLC-based method using automated precolumn derivatization with OPA and UV detection at 338 nm in serum and urine
Baseline, fasting day 10, food reintroduction day 3
Changes in amino acid metabolites
Time Frame: Baseline, fasting day 10, food reintroduction day 3
using a targeted approach in serum and urine
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-10 in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in G-CSF in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IFN-γ in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in TNF-α in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-1β in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-6 in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-8 in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-17 in blood
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in blood with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-10 in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in G-CSF in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IFN-γ in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in TNF-α in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-1β in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-6 in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-8 in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3
Changes in IL-17 in gingival crevicular fluid
Time Frame: Baseline, fasting day 10, food reintroduction day 3
analysed in gingival crevicular fluid with Bio-Plex 200 Suspension array System
Baseline, fasting day 10, food reintroduction day 3

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Rosenberg scale
Time Frame: daily from baseline to the 3rd day of food reintroduction
organoleptic intensity scale for measuring oral malodor: 0 = no odor to 5 = intense odor
daily from baseline to the 3rd day of food reintroduction
Changes in Seemann scale
Time Frame: daily from baseline to the 3rd day of food reintroduction
organoleptic assessment: 1 = odor noticable from 10 cm to 3 = odor noticeable from 1m
daily from baseline to the 3rd day of food reintroduction
Changes in Ayurvedic diagnosis of the tongue
Time Frame: daily from baseline to the 3rd day of food reintroduction
examination of the tongue
daily from baseline to the 3rd day of food reintroduction
Changes in urinary ketone bodies
Time Frame: daily from baseline to the 3rd day of food reintroduction
using ketostix
daily from baseline to the 3rd day of food reintroduction
Changes in capillary blood ketones
Time Frame: daily from baseline to the 3rd day of food reintroduction
using GlucoMen areo 2k
daily from baseline to the 3rd day of food reintroduction
Changes in capillary blood glucose
Time Frame: daily from baseline to the 3rd day of food reintroduction
using GlucoMen areo 2k
daily from baseline to the 3rd day of food reintroduction
Changes in ph value of the urin
Time Frame: daily from baseline to the 3rd day of food reintroduction
using test strips
daily from baseline to the 3rd day of food reintroduction
Changes in weight
Time Frame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
kg
daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
Changes in blood pressure
Time Frame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
systolic and diastolic in mmHg
daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
Changes in pulse
Time Frame: daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
beats per minute
daily from baseline to the 3rd day of food reintroduction as well as 1 and 3 months after
Plaque Index score
Time Frame: baseline
Sillness & Loe, 1964: from 0 = no plaque to 3 = abundant plaque along the gingival margin, interdental spaces filled with plaque
baseline
Gingival index score
Time Frame: baseline
Löe & Sillness, 1963: from 0 = normal gingiva to 3 = severe inflammation
baseline
Probing pocket depth
Time Frame: baseline
Bleeding on probing, recorded as present within 30 sec (1) or absent (0)
baseline
clinical attachment level
Time Frame: baseline
distance between the cemento-enamel junction and the tip of the graduated steel
baseline
recession
Time Frame: baseline
distance between CEJ and marginal edge of the free gingiva
baseline
Changes in leucocytes
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(thousands/µl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in erythrocytes
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(millions/µl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in haemoglobin
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(g/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in haematocrit
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(in %)
Baseline, fasting day 10, and food reintroduction day 3
Changes in MCV
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(fl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in MCH
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(pg)
Baseline, fasting day 10, and food reintroduction day 3
Changes in MCHC
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(g/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in thrombocytes
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(thousands/µl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in international normalized ratio
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
ratio
Baseline, fasting day 10, and food reintroduction day 3
Changes in Quick
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(in %)
Baseline, fasting day 10, and food reintroduction day 3
Changes in partial thromboplastin time
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(sec)
Baseline, fasting day 10, and food reintroduction day 3
Changes in aspartate aminotransferase (AST/GOT)
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(U/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in alanine aminotransferase (ALT/GPT)
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(U/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in gamma-glutamyl transferase (GGT)
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(U/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in alkaline phosphatase
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(U/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in uric acid
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in urea
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in glomerular Filtration Rate (GFR)
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(ml/min/1.73m2KOF)
Baseline, fasting day 10, and food reintroduction day 3
Changes in creatinine
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in thyroid-stimulating hormone (TSH)
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mE/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in total cholesterol
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in triglyceride
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in high-density lipoprotein (HDL)
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in low-density lipoprotein (LDL)
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in LDL / HDL - ratio
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
ratio
Baseline, fasting day 10, and food reintroduction day 3
Changes in glucose
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/dl)
Baseline, fasting day 10, and food reintroduction day 3
Changes in HbA1c
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mmol/mol)
Baseline, fasting day 10, and food reintroduction day 3
Changes in sodium
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mmol/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in potassium
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mmol/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in calcium
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mmol/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in magnesium
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mmol/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in erythrocyte sedimentation rate
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mm/h)
Baseline, fasting day 10, and food reintroduction day 3
Changes in C - reactive protein
Time Frame: Baseline, fasting day 10, and food reintroduction day 3
(mg/l)
Baseline, fasting day 10, and food reintroduction day 3
Changes in pH value of saliva
Time Frame: Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards
(mol/l)
Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Buchinger Wilhelmi Development & Holding GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London
University of Geneva, Switzerland
ETH Zurich (Switzerland)
Buchinger Wilhelmi Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Françoise Wilhelmi de Toledo, MD, Buchinger Wilhelmi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BuWi_OralFast_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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