Status:
UNKNOWN
Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation
Lead Sponsor:
Jinling Hospital, China
Conditions:
Slow Transit Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the synergism of Soluble Dietary Fiber with Fecal Microbiota Transplantation in Adult Patients with Slow Transit Constipation.
Detailed Description
Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Recent evidence in the literature and collected in our laboratory confirm that constipation c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02291354
Start Date
March 1 2015
End Date
June 1 2016
Last Update
February 4 2016
Active Locations (1)
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1
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002