A Randomized, Controlled Study of Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Proportion of patients having on average three or more SCBMs/week
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
FMT + Placebo
Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks.
Intervention: Placebo (Other)
FMT + Placebo
Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks.
Intervention: Fecal microbiota transplantation (FMT) (Procedure)
FMT + Pectin
Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks.
Intervention: Pectin (Drug)
FMT + Pectin
Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks.
Intervention: Fecal microbiota transplantation (FMT) (Procedure)
Outcomes
Primary Outcomes
Proportion of patients having on average three or more SCBMs/week
Time Frame: 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 Outcomes
- Colonic transit time measurements(12 weeks)
- Usage of laxatives or enemas as rescue medication(12 weeks)
- Bowel habit assessments(12 weeks)
- Constipation-related symptoms assessments(12 weeks)
- Quality-of-Life assessments(12 weeks)
- Adverse events(12 weeks)
Investigators
Jianfeng Gong
Associate professor
Jinling Hospital, China