Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT + Placebo | Placebo Comparator | Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks. |
|
| FMT + Pectin | Experimental | Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pectin | Drug | Patients allocated to experiment group will receive 12 g pectin each day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Constipation-related symptoms assessments |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfeng Gong, MD | Contact | +86-25-80860036 | jinlingh_gongjf@126.com | |
| Ning Li, MD | Contact | +86-25-80860089 | jinlingh_lining@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li, MD | Department of Generay Surgery, Jinling hosptal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210002 | China |
Not provided
| ID | Term |
|---|---|
| D010368 | Pectins |
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Patients allocated to experiment group will receive 12 g maltodextrin each day for 12 weeks. |
|
| Fecal microbiota transplantation (FMT) | Procedure | Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube. |
|
|
Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12. |
| 12 weeks |
| Quality-of-Life assessments | Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PACQOL) self-report questionnaire at week 4 and 12. | 12 weeks |
| Colonic transit time measurements | Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method. | 12 weeks |
| 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. | 12 weeks |
| Adverse events | Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders. | 12 weeks |
| D002241 |
| Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |