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

NCT05449249 | Completed

• 1 other identifier: BuWi_OralFast_2022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Periodontitis

Keywords

oral microbiota; intestinal microbiota; inflammatory status; redox status; sulfur metabolism; halitosis

Outcome Measures

Primary Outcomes (6)

• Changes in halitosis

  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

  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

  16 rRNA gene amplicon sequencing

  Baseline, fasting day 10, food reintroduction day 3, 1 and 3 months afterwards

• Changes in microbiota composition in faeces

  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)

  (mmol DPPH/L)

  Baseline, fasting day 3, 5, 10

• Changes in hydrogen sulfide production capacity

  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 Outcomes (34)

• Changes in glutathione (GSH)

  Baseline, fasting day 3, 5, 10

• Changes in thiobarbituric acid reactive substances (TBARS)

  Baseline, fasting day 3, 5, 10

• Changes in malondialdehyde (MDA)

  Baseline, fasting day 3, 5, 10

• Changes in protein carbonyls

  Baseline, fasting day 3, 5, 10

• Changes in nicotinamide adenine dinucleotide phosphate (NADPH) oxidase

  Baseline, fasting day 3, 5, 10

Other Outcomes (49)

• Changes in Rosenberg scale

  daily from baseline to the 3rd day of food reintroduction

• Changes in Seemann scale

  daily from baseline to the 3rd day of food reintroduction

• Changes in Ayurvedic diagnosis of the tongue

  daily from baseline to the 3rd day of food reintroduction

Study Arms (1)

Long-term fasting

EXPERIMENTAL

Long-term fasting according to the Buchinger Wilhelmi fasting program.

Procedure: Long-term fasting

Interventions

Long-term fasting PROCEDURE

The participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision.

Long-term fasting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Buchinger Wilhelmi Development & Holding GmbH: lead
• Buchinger Wilhelmi Clinic: collaborator
• University of Geneva, Switzerland: collaborator
• King's College London: collaborator
• ETH Zurich (Switzerland): collaborator

Study Sites (1)

Buchinger Wilhelmi clinic

Überlingen, 88662, Germany

Location

MeSH Terms

Conditions

Periodontitis; Halitosis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Françoise Wilhelmi de Toledo, MD

  Buchinger Wilhelmi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director; Principal Investigator

Model Details: single-arm, prospective, monocentric, interventional study

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 8, 2022
• Study Start: September 1, 2022
• Primary Completion: October 8, 2022
• Study Completion: January 6, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)