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

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.

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Key information

Conditions

Intermittent Islamic Fasting in Metabolic Syndrome Ramadan Fasting

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Department of Precision and Regenerative Medicine and Ionian Area (DiMePre-J - Clinica medica "A. Murri"

Bari, BA, 70124, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Changes in Intestinal Permeability Markers

Time frame: One month

Zonulin 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 outcomes

Effect of RIF on Gut Microbiota Composition

Time frame: 1 month

Fecal 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

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: May 19, 2026
Registry last updated: Jun 16, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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