Clinical trial NCT02984969: Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation Patients
Official title: Characterization of Intestinal Microbiota in Constipation Patients: Using 16S rRNA Gene Sequencing Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Slow Transit Constipation
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 18 subjects met the Rome III criteria for STC and 17 healthy controls were recruit from Jinling Hospital, a teaching hospital of Nanjing University

Brief summary: Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms and thus has several clinical definitions. According to the Rome III criteria for chronic constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it is more prevalent and symptomatic in women and elderly people. Slow transit constipation (STC) is the major category and is characterized by a decreased rate of colonic transit.

Recently, many researchers have focused on the relationship between intestinal microbiota and constipation and have demonstrated that intestinal microbiota contribute to the pathophysiology of functional gastrointestinal disorders.

Thus, there is a need for an improved understanding of gut microbiota composition in constipation patients and for the potential role played by the gut microbiota in the etiology of STC.To achieve this goal the investigators characterized and compared the intestinal microbiota among carefully selected patients with constipation that were clinically categorized based on Rome III criteria, and healthy controls using high throughput pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative changes in the relative abundances of taxa.


Eligibility criteria: Inclusion Criteria:

1. Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;
2. Age \> 18 years;
3. BMI: 18.5-25 kg/m2;
4. Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) \> 48 hours);
5. Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
6. No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast;
7. Disease duration \> 1 year;
8. Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;

Exclusion Criteria:

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

Primary outcomes:
measure: Fecal microbiota sequence
timeFrame: Within a week after enroll
Secondary outcomes:
measure: Stool short-chain fatty acids (SCFAs)
timeFrame: Within a week after enroll
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
name: Hongliang Tian
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tian H, Chen Q, Yang B, Qin H, Li N. Analysis of Gut Microbiome and Metabolite Characteristics in Patients with Slow Transit Constipation. Dig Dis Sci. 2021 Sep;66(9):3026-3035. doi: 10.1007/s10620-020-06500-2. Epub 2020 Aug 7.