This trial is active, not recruiting.

Condition slow transit constipation
Treatments fecal microbiota transplantation (fmt), vancomycin and bowel lavage
Phase phase 2
Sponsor Jinling Hospital, China
Start date January 2015
End date September 2016
Trial size 60 participants
Trial identifier NCT02301221, RIGS-FMT-STC-2014


The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients included will receive standard FMT, and then will be followed up for 12 weeks.
fecal microbiota transplantation (fmt) Fecal bacteriotherapy
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
vancomycin and bowel lavage
An initial vancomycin regimen (500 mg orally two times per day for 3 days), followed by bowel lavage before the infusion of a solution of donor fecal microbiota.

Primary Outcomes

Proportion of patients having on average three or more SCBMs/week
time frame: 24 weeks

Secondary Outcomes

Bowel habit assessments
time frame: 24 weeks
Constipation-related symptoms assessments
time frame: 24 weeks
Quality-of-Life assessments
time frame: 24 weeks
Colonic transit time measurements
time frame: 24 weeks
Usage of laxatives or enemas as rescue medication
time frame: 24 weeks
Adverse events
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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; - Age ≥ 18 years; - BMI: 18.5-25 kg/m2; - Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) > 48 hours); - Normal anorectal manometry with no evidence of dyssynergia and confirmed ability to expel rectal balloon; - 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; - Disease duration > 1 year; - Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success; Exclusion Criteria: - Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders); - History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ; - Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section; - Previous proctological or perianal surgery; - 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 and/or synbiotics within the last month; - Usage of antibiotics and/or PPIs within the last 3 months; - Smoking or alcohol addiction within the last 3 months; - Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease; - Disease or therapy with drugs (i.e. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.

Additional Information

Official title A Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Description Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Constipation frequency appears to augment with increasing age, particularly after 65 years old. Recent evidence in the literature and collected in our laboratory confirm that constipation can be a consequence of intestinal dysbiosis, with an increase of potentially pathogenic microorganisms and a decrease of potentially beneficial microorganisms. These alterations may affect the motility and metabolic environment of colon, especially the production of short chain fatty acids (SCFAs). A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI) and other extraintestinal conditions (e.g. IBD). Similarly, we suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Jinling Hospital, China.