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Gut Microbiota and Intestinal Permeability Responses to Ramadan Intermittent Fasting in Italian and Lebanese Cohorts: a Real-life Study

Gut Microbiota and Intestinal Permeability Responses to Ramadan Intermittent Fasting in Italian and Lebanese Cohorts: a Real-life Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07596875
Enrollment
79
Registered
2026-05-19
Start date
2024-03-11
Completion date
2024-05-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Islamic Fasting in Metabolic Syndrome, Ramadan Fasting

Keywords

Ramadan intermittent fasting, Microbiota, Intestinal permeability

Brief summary

Ramadan Intermittent Fasting (RIF) is an annual fasting month from dawn to sunset, practiced by healthy Muslims. While its metabolic benefits are well studied, its effects on the gastrointestinal (GI) tract, intestinal permeability, and GI microbiota remain less explored. This study investigated the effects of RIF on gut microbiota composition and markers of intestinal permeability in two distinct populations, i.e., Italy and Lebanon. Participants from Italy and Lebanon were enrolled in this observational longitudinal study and were monitored before, during, and after RIF. Dietary intake was assessed through a validated 3-day food questionnaire before and during RIF. Blood and fecal samples were collected to analyze the markers of intestinal permeability (zonulin, lipopolysaccharide (LPS), Fatty Acid Binding Protein 2 (FABP2), and total bile acids (TBA), and gut microbiota composition using the 16S rRNA gene sequencing.

Detailed description

The study has been developed as a clinical trial. It is expected the signing of the informed consent and authorization to the personal data. A total of 79 subjects aging between 20 and 60 years, homogeneous for sex and body mass index were enrolled in the study. Subjects were required to practice a 29/30 days of religeous fasting. Blood and fecal samples collected before RIF were obtained during the three days preceding RIF (days -3 to -1), whereas samples collected after RIF were obtained during the three days following the end of RIF. Blood samples were analyzed for markers of intestinal permeability, and fecal samples were used for gastrointestinal microbiome analysis. Moreover, each participant completed a validated dietary assessment using a 3-day food record questionnaire, administered during the three days immediately preceding RIF (days -3, -2, -1) and again during RIF (days 14, 15, and 16).

Interventions

None listed

Sponsors

University of Bari
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* subjects able to provide signed consent * age between 20-60 years * Healthy Volunteers

Exclusion criteria

* Lack of informed consent * pregnancy * celiac disease * diagnosis of organic diseases, cardiovascular risk * medications that can affect the gastrointestinal tract and interfere with symptoms

Design outcomes

Primary

MeasureTime frameDescription
Changes in Intestinal Permeability MarkersOne monthZonulin and LPS levels were measured through ELISA experiments where blood serum was collected from patients before and after the ending of the fasting month.

Secondary

MeasureTime frameDescription
Effect of RIF on Gut Microbiota Composition1 monthFecal samples were collected from patients at baseline and at the end of the fasting month for the aim of 16S rRNA analysis to see how the microbiota composition will be affected by this one fasting month

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORPiero Portincasa

Department of Precision and Regenerative Medicine and Ionian Area (DiMePre-J) University of Bari 'Aldo Moro'

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026