ConstipationNCT02395484
Metagenome Analysis of Gut Microbiota in CC Patients
An observational study of Constipation, run by Jinling Hospital, China at 1 site in China.
Trial summary
Constipation is a heterogeneous and multifactorial disease, influenced by a number of different genetic and environmental factors. By applying the standard two-stage GWAS strategy to design and carry out a metagenome-wide association study (MGWAS) to find the relationship between gut microbiota and constipation, to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Jun 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 faecal samples were obtained from constipation patients and 50 faecal samples were obtained from healthy volunteers
Who may be able to join
- Chronic constipation according to Rome III criteria;
- Age ≥ 18 years;
- BMI: 18.5-25kg/m2;
Who cannot join
- Bowel constipation due to innate factor (e.g. megacolon) or secondary interventions (e.g. drugs, endocrine, metabolic, neurologic or psychologic disorders);
- History or evidence of gastrointestinal diseases (e.g. cancer, inflammatory bowel diseases);
- Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
- Previous proctological or perianal surgery;
- Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA classification;
- A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
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- Pregnant or breast-feeding women;
- Infection with enteric pathogen;
- Usage of probiotics, prebiotics, antibiotics or PPIs within the last month;
- Smoking or alcohol addiction within the last 3 months;
- Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
- Disease or therapy with drugs (e.g. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210000
Ning Li, MD, +86-25-80860089, jinlingh_lining@126.com
About this study
Official title: Species and Metagenome Analysis of Gut Microbiota in Chronic Constipation Patients
Constipation is a heterogeneous and multifactorial disease, influenced by a number of different genetic and environmental factors. By applying the standard two-stage GWAS strategy to design and carry out a metagenome-wide association study (MGWAS) to find the relationship between gut microbiota and constipation, to identify disease-associated metagenomic markers.
Read the detailed description
This study is a two-stage case-control metagenome-wide association study (MGWAS) based on deep next-generation shotgun sequencing of DNA extracted from the stool samples from a total of 50 Chinese constipation patients and healthy controls.
- Conditions
- Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| constipation | collect stool samples from constipation patients | |
| healthy controls | collect stool samples from healthy controls patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
taxonomic and functional characterization of gut microbiota
Measured: one year
Secondary outcomes (2)
Gut-microbiota-based constipation classification
Measured: one year
constipation-associated gut microbial markers
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Chao Ding, MD, Principal investigator, Department of Generay Surgery, Jinling hospitalHongliang Tian, PhD, Principal investigator, Department of Generay Surgery, Jinling hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395484
- Sponsor's protocol ID
- MetagenomeNanjing
- Status last verified
- May 2015
- First submitted
- 17 Mar 2015
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Species and Metagenome Analysis of Gut Microbiota in Chronic Constipation Patients
- ClinicalTrials.gov ID
- NCT02395484
- Acronym / sponsor ID
- MetagenomeNanjing
- Conditions
- Constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 23 Mar 2015 (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.
Constipation is a heterogeneous and multifactorial disease, influenced by a number of different genetic and environmental factors. By applying the standard two-stage GWAS strategy to design and carry out a metagenome-wide association study (MGWAS) to find the relationship between gut microbiota and constipation, to identify disease-associated metagenomic markers.
Detailed description
This study is a two-stage case-control metagenome-wide association study (MGWAS) based on deep next-generation shotgun sequencing of DNA extracted from the stool samples from a total of 50 Chinese constipation patients and healthy controls.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| constipation | – | –collect stool samples from constipation patients |
| healthy controls | – | –collect stool samples from healthy controls patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 faecal samples were obtained from constipation patients and 50 faecal samples were obtained from healthy volunteers
Key inclusion criteria (3 listed)
- Chronic constipation according to Rome III criteria;
- Age ≥ 18 years;
- BMI: 18.5-25kg/m2;
Key exclusion criteria (12 listed)
- Bowel constipation due to innate factor (e.g. megacolon) or secondary interventions (e.g. drugs, endocrine, metabolic, neurologic or psychologic disorders);
- History or evidence of gastrointestinal diseases (e.g. cancer, inflammatory bowel diseases);
- Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
- Previous proctological or perianal surgery;
- Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA classification;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
taxonomic and functional characterization of gut microbiota
Time frame: one year
2 secondary outcomes
Gut-microbiota-based constipation classification
Time frame: one year
constipation-associated gut microbial markers
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
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Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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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.
Chao Ding, MD principal investigator
Department of Generay Surgery, Jinling hospital
Hongliang Tian, PhD principal investigator
Department of Generay Surgery, Jinling hospital
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 Constipation, run by Jinling Hospital, China 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 3 inclusion and 12 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 4 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, MD (+86-25-80860089, jinlingh_lining@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
taxonomic and functional characterization of gut microbiota (time frame: one year). 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 4 May 2015.