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Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation

Primary Purpose

Slow Transit Constipation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pectin
Placebo
Fecal microbiota transplantation (FMT)
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Slow Transit Constipation focused on measuring Fecal Microbiota Transplantation, Soluble Dietary Fiber, Slow Transit Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

FMT + Placebo

FMT + Pectin

Arm Description

Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks.

Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Colonic transit time measurements
Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.
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.
Adverse events
Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.

Full Information

First Posted
November 11, 2014
Last Updated
February 3, 2016
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02291354
Brief Title
Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation
Official Title
A Randomized, Controlled Study of Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Slow Transit Constipation
Keywords
Fecal Microbiota Transplantation, Soluble Dietary Fiber, Slow Transit Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT + Placebo
Arm Type
Placebo Comparator
Arm Description
Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks.
Arm Title
FMT + Pectin
Arm Type
Experimental
Arm Description
Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Pectin
Other Intervention Name(s)
soluble dietary fiber
Intervention Description
Patients allocated to experiment group will receive 12 g pectin each day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients allocated to experiment group will receive 12 g maltodextrin each day for 12 weeks.
Intervention Type
Procedure
Intervention Name(s)
Fecal microbiota transplantation (FMT)
Other Intervention Name(s)
Fecal bacteriotherapy
Intervention Description
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Primary Outcome Measure Information:
Title
Proportion of patients having on average three or more SCBMs/week
Description
Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at week 4 and 12.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Bowel habit assessments
Description
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.
Time Frame
12 weeks
Title
Constipation-related symptoms assessments
Description
Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12.
Time Frame
12 weeks
Title
Quality-of-Life assessments
Description
Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PACQOL) self-report questionnaire at week 4 and 12.
Time Frame
12 weeks
Title
Colonic transit time measurements
Description
Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.
Time Frame
12 weeks
Title
Usage of laxatives or enemas as rescue medication
Description
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.
Time Frame
12 weeks
Title
Adverse events
Description
Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Gong, MD
Phone
+86-25-80860036
Email
jinlingh_gongjf@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, MD
Phone
+86-25-80860089
Email
jinlingh_lining@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Organizational Affiliation
Department of Generay Surgery, Jinling hosptal
Official's Role
Study Director
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Phone
+86-25-80860089
Email
jinlingh_lining@126.com
First Name & Middle Initial & Last Name & Degree
Jianfeng Gong, MD
First Name & Middle Initial & Last Name & Degree
Chao Ding, MD candidate
First Name & Middle Initial & Last Name & Degree
Hongliang Tian, PhD candidate
First Name & Middle Initial & Last Name & Degree
Xiaolong Ge, MD candidate

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation

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