Slow Transit Constipation Clinical Trial
Official title:
A Randomized Controlled Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2017 |
Est. primary completion date | December 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), 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 week 4 and 12. | 3 months | No |
Secondary | Mean number of bowel movements per week | Patients kept daily diaries about times of bowel movements each day. | 3 months | No |
Secondary | Characteristics of bowel movements | Patients kept daily diaries about stool consistency and degree of straining severity during defecation. | 3 months | No |
Secondary | Constipation-related symptoms assessments | Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12. | 3 months | 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 week 4 and 12. | 3 months | No |
Secondary | Colonic transit time measurements | Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method. | 3 months | 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 was used. Patients kept daily diaries about the rescue medication when used. | 3 months | No |
Secondary | Adverse events | Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders. | 3 months | Yes |
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