Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation
- Conditions
- Slow Transit Constipation
- Interventions
- Registration Number
- NCT02291354
- Lead Sponsor
- Jinling Hospital, China
- 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 can be a consequence of intestinal dysbiosis, which may affect the motility and metabolic environment of colon.
Fecal Microbiota Transplantation (FMT) is temporarily effective for patients with slow transit constipation. However, the transplanted microflora cannot maintain for a long time. Along with the gut microbiota returning to the original state, the symptoms relapse.
Pectin is a kind of soluble dietary fiber, producing short chain fatty acids (SCFAs) after a series of fermentation by gut flora to supply the energy for epithelial cells, regulate intestinal PH, promote intestinal motility and join effort in immune regulation with intestinal lymphoid tissue. Therefore, we conceive that pectin could promote the colonization of probiotics and reduce adhesion of pathogens.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMT + Pectin Fecal microbiota transplantation (FMT) Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks. FMT + Placebo Placebo Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks. FMT + Placebo Fecal microbiota transplantation (FMT) Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks. FMT + Pectin Pectin Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks.
- Primary Outcome Measures
Name Time Method Proportion of patients having on average three or more SCBMs/week 12 weeks Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at week 4 and 12.
- Secondary Outcome Measures
Name Time Method Usage of laxatives or enemas as rescue medication 12 weeks 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.
Bowel habit assessments 12 weeks 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.
Constipation-related symptoms assessments 12 weeks Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12.
Quality-of-Life assessments 12 weeks Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PACQOL) self-report questionnaire at week 4 and 12.
Colonic transit time measurements 12 weeks Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.
Adverse events 12 weeks Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.
Trial Locations
- Locations (1)
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
🇨🇳Nanjing, Jiangsu, China