Effect of SC-FOS Prebiotics on Women with Polycystic Ovary Syndrome
To Study the Clinical Effect of SC-FOS Prebiotics in Enteral Diet vs. Standard Enteral Diet on Clinical Characteristics of Patients With Polycystic Ovary Syndrome According to the Rotterdam Classification in Chihuahua, Chihuahua. A Randomized Single-Blind Clinical Trial
This study is testing whether a type of prebiotic called SC-FOS can help improve symptoms in women with polycystic ovary syndrome (PCOS).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Universidad Autonoma de Chihuahua Academic / other |
| Locations | 1 site (Chihuahua) |
| Trial ID | NCT05999097 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of short-chain fructooligosaccharides (SC-FOS) on the clinical characteristics of women diagnosed with polycystic ovary syndrome (PCOS). Participants will be randomly assigned to receive either SC-FOS or a placebo administered enterally for 10 days. The study will assess changes in clinical manifestations of PCOS following the intervention. Informed consent will be obtained from all participants prior to random assignment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 65 with a diagnosis of polycystic ovary syndrome who can utilize enteral feeding.
Not a fit: Patients who are pregnant, have diabetes mellitus, or are at risk of intestinal perforation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention to improve clinical outcomes for women with PCOS.
How similar studies have performed: While there is limited data on the specific use of SC-FOS for PCOS, similar dietary interventions have shown promise in managing related metabolic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex * Age 18 to 65 years * Polycystic Ovary Syndrome diagnosed by specialist * Useful enteral feeding Exclusion Criteria: * Pregnancy * Diabetes mellitus * Risk of intestinal perforation
Where this trial is running
Chihuahua
- Hospital Central del Estado de Chihuahua — Chihuahua, Mexico (Recruiting)
Study contacts
- Study coordinator: Carolina Martinez Loya
- Email: caromtzloya@gmail.com
- Phone: 6143543923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.