The Rufaida Project: Researching the Impact of Ramadan Fasting on the Gut and Vaginal Microbiome

NCT07001358 | Active Not Recruiting

• 1 other identifier: BUN B3002024000242
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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 present in the vaginal microbiome. This finding supports the idea that gut and vaginal bacteria interact closely, a connection known as the gut-vagina axis. However, it remains unclear whether changes in gut bacteria influence the vaginal microbiome. This discovery led to an exploration of how diet affects both the gut and vaginal microbiomes. In the gut, bacteria rely on carbohydrates from food, while in the vagina, bacteria feed on glycogen, a sugar stored in the vaginal lining. This glycogen is broken down into smaller sugars, which beneficial Lactobacillus bacteria use for fermentation. Since starch is a major source of these sugars, researchers suspect that a starch-rich diet may support Lactobacillus growth, which in turn promotes vaginal health. To test this hypothesis, the Rufaida Project was launched. Ramadan is characterised by a fasting period of approximately one month during which participants abstain from eating between sunrise and sunset. Ramadan provides a unique opportunity to study how fasting affects the microbiome under controlled conditions. In this study, 50 Muslim women will be asked to provide vaginal and stool samples at eight predetermined time points-before, during, and after Ramadan. These samples will be analysed using 16S rRNA amplicon sequencing to determine bacterial composition. Comparative analysis will be conducted between samples across different time points and anatomical sites. The objective is to understand how fasting and dietary changes influence the gut and vaginal microbiomes, and whether gut bacteria play a role in shaping vaginal health. Additionally, participants will complete weekly health questionnaires. An additional study group of up to 300 Muslim women will complete weekly questionnaires without providing biological samples. This research could improve understanding of the links between diet, gut health, and vaginal health, potentially leading to new strategies for enhancing women's well-being through nutrition.

Conditions

Intermittent Fasting; Gut Microbiome; Vaginal Microbiome

Keywords

Vaginal microbiome; Gut microbiome; Intermittent fasting; Ramadan; Gut-vagina axis; Citizen science

Outcome Measures

Primary Outcomes (1)

• Characterizing the gut and vaginal microbiome in relation to dietary components and meal frequency during ramadan using 16S rRNA sequencing

  To investigate the potential influence of dietary components and meal frequency on the gut and vaginal microbiome, vaginal and stool samples will be collected from participants before, during, and after a period of intermittent fasting (Ramadan). Bacterial community composition will be determined using 16S rRNA amplicon sequencing by Illumina MiSeq analysis. Bioinformatic tools will be employed to assess taxonomic profiles across different time points and anatomical sites. Particular attention will be given to correlations between gut- and vaginal-associated microbial taxa, with the aim of identifying bacterial signatures potentially shaped by dietary changes and fasting patterns. The analysis will further explore whether specific gut microbiota are associated with the presence or modulation of vaginal microbial communities, with a focus on health-promoting taxa such as Lactobacillus species.

  up to 4 years

Secondary Outcomes (2)

• Determining changes in psychological well-being during Ramadan through longitudinal questionnaires

  Up to 4 years

• Characterization of metabolite profiles in vaginal and stool samples before, during, and after Ramadan fasting

  Up to 4 years

Study Arms (1)

Women participating in Ramadan

Healthy volunteers that plan on intermittent fasting during the month of Ramadan 2025. No food or drink will be consumed from sunrise until sundown

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers participating in Ramadan 2025 will be recruited through various channels. The selected women can join select to join group 1 (n=50) that take biological samples and fill out weekly questionnaires, or group 2 (n=300) that fill out weekly questionnaires.

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University of Antwerp

Antwerp, 2020, Belgium

Location

Related Links

• Webpage about the study for participants
• Blogpost explaining the study and studygroups to possible participants

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal swabs with human and microbial DNA Stool swabs with human and microbial DNA Stool dry samples with human and microbial DNA

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Sarah Lebeer, Professor

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: June 3, 2025
• Study Start: February 4, 2025
• Primary Completion: May 30, 2025
• Study Completion: February 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Following publication, the results associated with each study will also be deposited in the Dryad repository, where they will be preserved indefinitely. Sequences will be stored to ENA (public databases) and NCBI. All samples will be registered in the Biobank using the SLIMS system.
• Access Criteria: A guide to data access on the EGA is available at https://ega-archive.org/access/data-access, and a data access request will be processed within 2-3 months, pending evaluation by the data access committee (existing of lab members involved in the study), and processing by the EGA.

Locations

BE (1)