Polycystic Ovary SyndromeNCT05999097
To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome
A study testing Short Chain Fructooligosaccharides in people with Polycystic Ovary Syndrome, run by Universidad Autonoma de Chihuahua at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Short Chain Fructooligosaccharides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 2 Dec 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female sex
- Age 18 to 65 years
- Polycystic Ovary Syndrome diagnosed by specialist
- Useful enteral feeding
Who cannot join
- Pregnancy
- Diabetes mellitus
- Risk of intestinal perforation
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Central del Estado de Chihuahua
Chihuahua City, 31000
Carolina Martínez Loya, M.D., +526143543923, caromtzloya@gmail.com
Ruth S Favela Ortiz, 6142277559 ext. +52, rfavelaortiz@gmail.com
About this study
Official title: 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
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.
Read the detailed description
The protocol will be discussed with the patients and/or relatives of the patients, who will understand the consequences and advantages of the study and will thus sign the consent.
Once informed consent has been obtained, the group to which each patient belongs will be randomly assigned.
Patients will be selected according to the inclusion and exclusion criteria of the population diagnosed with PCOS with useful enteral route for random assignment into two groups, one will be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours, another group will be given saline as a placebo to the enteral diet every 24 hours for 10 days. Patients should take the solution on an empty stomach.
Once the type of intervention has been determined, the patient will be given the suspensions corresponding to group 1 or placebo, with vials in which the content cannot be visualized, numbered according to the sheet obtained by the corresponding randomization. The initial evaluation will be completed with all the clinical characteristics to be evaluated.
The patient will be told that every 24 hours he must take 1 suspension on an empty stomach, which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the prebiotic preparation vs 15 cc of saline solution for the placebo group. The solution will be administered enterally for 10 consecutive days at a single dose per day, and a reassessment will be made on the seventh day of the clinical characteristics of the patients, to compare and evaluate the results.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Short Chain Fructooligosaccharides, Placebo Group
- Keywords
- Polycystic Ovary Syndrome, Prebiotics, Enteral Diet, Clinical Manifestations, SC-FOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Chain FructooligosaccharidesDietary supplement
Also called Prebiotics
The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.
Placebo GroupDietary supplement
Also called Placebo
This group will receive 12 g of corn starch as a control group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- Limitations in physical activities because of health problems.
- Limitations in social activities because of physical or emotional problems
- Limitations in usual role activities because of physical health problems
- Bodily pain
- General mental health (psychological distress and well-being)
- Limitations in usual role activities because of emotional problems
- Vitality (energy and fatigue)
- General health perceptions
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start2 Dec 2024 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study, randomized single blind clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Chihuahua
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Martínez Loya, MD, Universidad Autonoma de Chihuahua
- Investigators
- Luis B Enríquez-Sánchez, Study director, Universidad Autonoma de Chihuahua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999097
- Sponsor's protocol ID
- 030C-06/23
- Status last verified
- Feb 2024
- First submitted
- 11 Aug 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data obtained from this research study will be available if requested once the study is finalized.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05999097
- Acronym / sponsor ID
- 030C-06/23
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Prebiotics, Enteral Diet, Clinical Manifestations, SC-FOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Autonoma de ChihuahuaUniversity, hospital or other
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The protocol will be discussed with the patients and/or relatives of the patients, who will understand the consequences and advantages of the study and will thus sign the consent.
Once informed consent has been obtained, the group to which each patient belongs will be randomly assigned.
Patients will be selected according to the inclusion and exclusion criteria of the population diagnosed with PCOS with useful enteral route for random assignment into two groups, one will be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours, another group will be given saline as a placebo to the enteral diet every 24 hours for 10 days. Patients should take the solution on an empty stomach.
Once the type of intervention has been determined, the patient will be given the suspensions corresponding to group 1 or placebo, with vials in which the content cannot be visualized, numbered according to the sheet obtained by the corresponding randomization. The initial evaluation will be completed with all the clinical characteristics to be evaluated.
The patient will be told that every 24 hours he must take 1 suspension on an empty stomach, which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the prebiotic preparation vs 15 cc of saline solution for the placebo group. The solution will be administered enterally for 10 consecutive days at a single dose per day, and a reassessment will be made on the seventh day of the clinical characteristics of the patients, to compare and evaluate the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective study, randomized single blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Short Chain Fructooligosaccharides Group | Experimental | Dietary Supplement: Short Chain FructooligosaccharidesThis group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo GroupThis group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female sex
- Age 18 to 65 years
- Polycystic Ovary Syndrome diagnosed by specialist
- Useful enteral feeding
Key exclusion criteria (3 listed)
- Pregnancy
- Diabetes mellitus
- Risk of intestinal perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Chain FructooligosaccharidesAlso: PrebioticsThe intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water. | Dietary supplement | Short Chain Fructooligosaccharides Group |
| Placebo GroupAlso: PlaceboThis group will receive 12 g of corn starch as a control group. | Dietary supplement | Placebo Group |
Primary outcome
Score of Bristol Scale
Time frame: 10 days
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)
Score Short Form Health Survey (SF-36)
Time frame: 10 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Yes. The data obtained from this research study will be available if requested once the study is finalized.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis B Enríquez-Sánchez study director
Universidad Autonoma de Chihuahua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Chain Fructooligosaccharides in people with Polycystic Ovary Syndrome, run by Universidad Autonoma de Chihuahua at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Martinez Loya (6143543923 ext. +52, caromtzloya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Bristol Scale (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.