NCT05999097

Brief Summary

The purpose of this study is to determine if there is a difference in the clinical characteristics of patients with polycystic ovary syndrome after the administration of SC-FOS in the enteral diet compared to patients with a standard diet.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

August 11, 2023

Last Update Submit

February 1, 2024

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromePrebioticsEnteral DietClinical ManifestationsSC-FOS

Outcome Measures

Primary Outcomes (2)

  • Score of Bristol Scale

    Score obtained by Stool Consistency Bristol Scale: This scale consist in seven types of stool: Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)

    10 days

  • Score Short Form Health Survey (SF-36)

    Short Form Health Survey (SF-36) is a measure of health-related quality-of-life: It comprises 36 questions that cover eight domains of health 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions

    10 days

Study Arms (2)

Short Chain Fructooligosaccharides Group

EXPERIMENTAL

This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml

Dietary Supplement: Short Chain Fructooligosaccharides

Placebo Group

PLACEBO COMPARATOR

This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml

Dietary Supplement: Placebo Group

Interventions

Short Chain FructooligosaccharidesDIETARY_SUPPLEMENT

The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.

Also known as: Prebiotics
Short Chain Fructooligosaccharides Group
Placebo GroupDIETARY_SUPPLEMENT

This group will receive 12 g of corn starch as a control group.

Also known as: Placebo
Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female sex
  • Age 18 to 65 years
  • Polycystic Ovary Syndrome diagnosed by specialist
  • Useful enteral feeding

You may not qualify if:

  • Pregnancy
  • Diabetes mellitus
  • Risk of intestinal perforation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central del Estado de Chihuahua

Chihuahua City, 31000, Mexico

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Luis B Enríquez-Sánchez

    Universidad Autonoma de Chihuahua

    STUDY DIRECTOR

Central Study Contacts

Carolina Martinez Loya

CONTACT

6143543923caromtzloya@gmail.com

Ruth Favela Ortiz

CONTACT

6142277559rfavelaortiz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective study, randomized single blind clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 21, 2023

Study Start

December 2, 2024

Primary Completion

May 10, 2025

Study Completion

May 30, 2025

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

The data obtained from this research study will be available if requested once the study is finalized.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will be available for up to five years since completion of the study.
Access Criteria
The request for the data will be by e-mail

Locations

ME(1)