Overview

Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation

Status:
Unknown status
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jinling Hospital, China
Criteria
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.