Clinical trial NCT02395484: Metagenome Analysis of Gut Microbiota in CC Patients
Official title: Species and Metagenome Analysis of Gut Microbiota in Chronic Constipation Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constipation
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 faecal samples were obtained from constipation patients and 50 faecal samples were obtained from healthy volunteers

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Chronic constipation according to Rome III criteria;
2. Age ≥ 18 years;
3. BMI: 18.5-25kg/m2;

Exclusion Criteria:

1. Bowel constipation due to innate factor (e.g. megacolon) or secondary interventions (e.g. drugs, endocrine, metabolic, neurologic or psychologic disorders);
2. History or evidence of gastrointestinal diseases (e.g. cancer, inflammatory bowel diseases);
3. Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
4. Previous proctological or perianal surgery;
5. Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA classification;
6. A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
7. Pregnant or breast-feeding women;
8. Infection with enteric pathogen;
9. Usage of probiotics, prebiotics, antibiotics or PPIs within the last month;
10. Smoking or alcohol addiction within the last 3 months;
11. Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
12. 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.

Primary outcomes:
measure: taxonomic and functional characterization of gut microbiota
timeFrame: one year
Secondary outcomes:
measure: Gut-microbiota-based constipation classification
timeFrame: one year
measure: constipation-associated gut microbial markers
timeFrame: one year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Department of Generay Surgery, Jinling hospital
name: Chao Ding, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Generay Surgery, Jinling hospital
name: Hongliang Tian, PhD
role: PRINCIPAL_INVESTIGATOR
References: