Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation (NCT02676388) | Clinical Trial Compass
UnknownPhase 2
Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation
China50 participantsStarted 2015-06
Plain-language summary
The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh FMT in adults with slow transit constipation.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Us…
What they're measuring
1
Proportion of patients having on average three or more SCBMs/week