Gut Microbiota and Intestinal Permeability Responses to R... | NCT07596875

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

NCT07596875

Sponsor

University of Bari

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

79Actual

Phase

Not provided

Conditions

Intermittent Islamic Fasting in Metabolic Syndrome
Ramadan Fasting

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2024Actual

Primary Completion Date

Apr 9, 2024Actual

Completion Date

May 1, 2024Actual

First Submitted Date

May 12, 2026

First Submission Date that Met QC Criteria

May 12, 2026

First Posted Date

May 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

piero portincasa, Piero Portincasa , MD, PhD, Dr honoris. Causa ., AGAF Professor of internal medicine Chief, Clinica Medica "A. Murri" Director, Dept. Biomedical Sciences & Human Oncology, University of BariPrincipal Investigator

Lead Sponsor

University of BariOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Italian group		Muslims in Italy
Lebanese Group		Muslims in Lebanon

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Intestinal Permeability Markers	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.	One month

Secondary Outcomes

Measure	Description	Time Frame
Effect of RIF on Gut Microbiota Composition	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	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

should be muslims in which they are able to do one month of fasting without complications

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piero Portincasa	Department of Precision and Regenerative Medicine and Ionian Area (DiMePre-J) University of Bari 'Aldo Moro'	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Department of Precision and Regenerative Medicine and Ionian Area (DiMePre-J - Clinica medica "A. Murri"		Bari	BA	70124	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39191620	Background	Khalil M, Abdallah H, Jaber N, Garruti G, Di Ciaula A, Portincasa P. Distinct biophysiological effects of Ramadan fasting and traditional intermittent fasting on markers of body fat storage. A real-life study. Eur J Intern Med. 2024 Nov;129:111-120. doi: 10.1016/j.ejim.2024.08.014. Epub 2024 Aug 26.
37203871	Background