Polycystic Ovary SyndromeNCT02937090
Intestinal Microbiota Survey of Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of Polycystic Ovary Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Blood Draw and Stool collection
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Oct 2017
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Polycystic Ovary Syndrome patients and age, BMI-matched women.
Who may be able to join
- Premenopausal between 18-40 years of age.
- Exclusion of other etiologies for infertility.
Who cannot join
- During the pregnancy and lactation period.
- Use of antibiotics within 3 months.
- Regular use of proton pump inhibitors, laxatives or pro-prebiotics.
- Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
- Major changes in eating habits within the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
About this study
Official title: The Cross-sectional Study of Intestinal Microbiota in Women With Polycystic Ovary Syndrome and Its Association With Clinical and Biological Parameters
Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the investigators will compare the intestinal microbiota composition and diversity in PCOS with age, BMI-matched control and then assess whether intestinal microbiota modification is associated with clinical and biological parameters.
Read the detailed description
The goal of this study is to investigate and compare the composition of the intestinal microbiota in patients with PCOS and age, BMI-matched control. In addition, the investigators will investigate the relationship between alterations in the intestinal microbiota, clinical phenotype, biochemical analysis, body composition, inflammation and food consumption habit. The investigators hypothesize that alterations in the intestinal microbiota are associated with increased immune activation and progression of PCOS. Based on this hypothesis, the investigators propose the following aims:
Aim 1. Identify and enroll cohort with PCOS and age, BMI-matched control to study the role of intestinal microbiota on the development of PCOS.
- Enroll participants at Drum Tower Hospital. Identify and classify participants through initial clinical evaluation, collect clinical metadata, obtain and process blood and stool samples for analysis.
- Characterize the intestinal microbiota through quantitative PCR and high throughput sequencing analysis of stool specimens in participants.
Aim 2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic inflammation.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Blood Draw, Stool collection
- Keywords
- Polycystic Ovary Syndrome, Intestinal Microbiota
- 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.
Blood DrawOther
Blood sample will be drawn from participants at study entry.
Stool collectionOther
Stool will be collected from participants at study entry.
| Study group | Role | What they receive |
|---|---|---|
| Polycystic Ovary Syndrome | Premenopausal women between 18-40 years of age.
Diagnosed with PCOS using Rotterdam criteria (meet 2 of the 3):
1. chronic oligo- or amenorrhea (irregular periods during more than a year in combination with a cycle length longer than 35 days);
2. total or free T levels above the reference interval and/or excessive facial hair, acne;
3. transvaginal ultrasound with polycystic ovaries.
Exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency). Receives: Other: Blood Draw; Other: Stool collection | |
| Control | Women matched for age and BMI. Receives: Other: Blood Draw; Other: Stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis.
Measured: an average of 1 month
Secondary outcomes (1)
Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed.
Measured: an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017
- Study completionOct 2017
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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937090
- Sponsor's protocol ID
- PCOS2016
- Status last verified
- Nov 2017
- First submitted
- 14 Oct 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cross-sectional Study of Intestinal Microbiota in Women With Polycystic Ovary Syndrome and Its Association With Clinical and Biological Parameters
- ClinicalTrials.gov ID
- NCT02937090
- Acronym / sponsor ID
- PCOS2016
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Intestinal Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- 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.
Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the investigators will compare the intestinal microbiota composition and diversity in PCOS with age, BMI-matched control and then assess whether intestinal microbiota modification is associated with clinical and biological parameters.
Detailed description
The goal of this study is to investigate and compare the composition of the intestinal microbiota in patients with PCOS and age, BMI-matched control. In addition, the investigators will investigate the relationship between alterations in the intestinal microbiota, clinical phenotype, biochemical analysis, body composition, inflammation and food consumption habit. The investigators hypothesize that alterations in the intestinal microbiota are associated with increased immune activation and progression of PCOS. Based on this hypothesis, the investigators propose the following aims:
Aim 1. Identify and enroll cohort with PCOS and age, BMI-matched control to study the role of intestinal microbiota on the development of PCOS.
- Enroll participants at Drum Tower Hospital. Identify and classify participants through initial clinical evaluation, collect clinical metadata, obtain and process blood and stool samples for analysis.
- Characterize the intestinal microbiota through quantitative PCR and high throughput sequencing analysis of stool specimens in participants.
Aim 2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic inflammation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycystic Ovary Syndrome | – | Other: Blood Draw, Other: Stool collectionPremenopausal women between 18-40 years of age. Diagnosed with PCOS using Rotterdam criteria (meet 2 of the 3): 1. chronic oligo- or amenorrhea (irregular periods during more than a year in combination with a cycle length longer than 35 days); 2. total or free T levels above the reference interval and/or excessive facial hair, acne; 3. transvaginal ultrasound with polycystic ovaries. Exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency). |
| Control | – | Other: Blood Draw, Other: Stool collectionWomen matched for age and BMI. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Polycystic Ovary Syndrome patients and age, BMI-matched women.
Key inclusion criteria (2 listed)
- Premenopausal between 18-40 years of age.
- Exclusion of other etiologies for infertility.
Key exclusion criteria (5 listed)
- During the pregnancy and lactation period.
- Use of antibiotics within 3 months.
- Regular use of proton pump inhibitors, laxatives or pro-prebiotics.
- Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
- Major changes in eating habits within the past 3 months.
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 |
|---|---|---|
| Blood DrawBlood sample will be drawn from participants at study entry. | Other | Control, Polycystic Ovary Syndrome |
| Stool collectionStool will be collected from participants at study entry. | Other | Control, Polycystic Ovary Syndrome |
Primary outcome
Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis.
Time frame: an average of 1 month
1 secondary outcome
Correlation of intestinal microbiota composition with biological parameters of PCOS patients will be assessed.
Time frame: an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 6 Nov 2017. 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiota of stool samples of PCOS and age, BMI-matched control will be identified by quantitative analysis. (time frame: an average of 1 month). 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 6 Nov 2017.