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.