Metagenome Analysis of Gut Microbiota in CC Patients

NCT02395484 | Unknown DMC

• 1 other identifier: MetagenomeNanjing
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• taxonomic and functional characterization of gut microbiota

  one year

Secondary Outcomes (2)

• Gut-microbiota-based constipation classification

  one year

• constipation-associated gut microbial markers

  one year

Study Arms (2)

constipation

collect stool samples from constipation patients

healthy controls

collect stool samples from healthy controls patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 faecal samples were obtained from constipation patients and 50 faecal samples were obtained from healthy volunteers

You may qualify if:

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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chao Ding, MD

  Department of Generay Surgery, Jinling hospital

  PRINCIPAL INVESTIGATOR

• Hongliang Tian, PhD

  Department of Generay Surgery, Jinling hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, MD

CONTACT

+86-25-80860089; jinlingh_lining@126.com

Jianfeng Gong, MD

CONTACT

+86-25-80860036; gongjianfeng@aliyun.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 4, 2015

Record last verified: 2015-05

Locations

CN (1)