Slow Transit Constipation Clinical Trial
— FMTSTCOfficial title:
A Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Verified date | November 2016 |
Source | Jinling Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients having on average three or more SCBMs/week | Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at baseline and over the week interval 3-4, 9-12 and 21-24. | 24 weeks | No |
Secondary | Bowel habit assessments | Patients kept daily diaries about times of bowel movements each day, stool consistency, degree of straining severity during defecation, and degree of sensation of incompleteness of evacuation. | 24 weeks | No |
Secondary | Constipation-related symptoms assessments | Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline and at week 4, 12, and 24. | 24 weeks | No |
Secondary | Quality-of-Life assessments | Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PAC-QOL) self-report questionnaire at baseline and at week 4, 12, and 24. | 24 weeks | No |
Secondary | Colonic transit time measurements | Colonic transit time (CTT) was measured at baseline and at week 4, 12 and 24 with the Metcalf method. | 24 weeks | No |
Secondary | Usage of laxatives or enemas as rescue medication | If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax). If ineffective, enema were used. Patients kept daily diaries about the rescue medication when used. | 24 weeks | No |
Secondary | Adverse events | Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders. | 24 weeks | Yes |
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