Status:
ACTIVE_NOT_RECRUITING
The Rufaida Project: Researching the Impact of Ramadan Fasting on the Gut and Vaginal Microbiome
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Intermittent Fasting
Gut Microbiome
Eligibility:
FEMALE
18+ years
Brief Summary
The body's systems are deeply connected, but they are often studied separately. A recent large-scale citizen-science project on women's health, called Isala, discovered a group of gut-related bacteria...
Detailed Description
The objective of this observational study is to examine the impact of fasting on the vaginal and gut microbiomes. The study population comprises healthy female volunteers of reproductive age who parti...
Eligibility Criteria
Inclusion
- 18 years or older on the moment of registration
- Female (biological gender)
- Currently living in Belgium
- Sufficient knowledge of the Dutch language
- Participating in Ramadan
- Has signed the informed consent
Exclusion
- Breastfeeding at the start of and during the study
- Current diagnosis of cancer and/or immunosuppressive therapy in the six months before the study
- Cardiovascular and metabolic conditions (such as diabetes, irritable bowel syndrome, etc.)
- Clinically significant tendency to bleed throughout history;
- Clinically significant abnormalities of the reproductive organs;
- Any other medical condition that, in the judgment of the principal investigator, warrants exclusion from the study;
- Use of oral/vaginal antibiotics/antimycotics in the 2 months prior to the study;
- Use of oral/vaginal pre-, pro-, and postbiotics (i.e., supplements in addition to diet) in the 2 weeks before and during the study;
- Ketogenic diet in the 2 weeks before and during the study;
- Vaginal douching during the study;
- Concurrent participation in another clinical trial.
Key Trial Info
Start Date :
February 4 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07001358
Start Date
February 4 2025
End Date
February 1 2026
Last Update
June 3 2025
Active Locations (1)
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1
University of Antwerp
Antwerp, Belgium, 2020