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Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation

Primary Purpose

Slow Transit Constipation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fecal microbiota transplantation (FMT)
Conventional treatment
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, Slow Transit Constipation, Randomized Controlled Trial

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

Experimental

Experimental

Arm Label

Fecal microbiota transplantation (FMT)

Conventional treatment

Arm Description

On day 1-6, patients received 100ml fresh FMT by nasointestinal tube, once per day. The nasointestinal tube was placed in the patient's proximal jejunum through endoscopy. Then, donor fecal microbiota was infused within 5 minutes through nasointestinal tube.

Conventional treatment was taken by both of two groups. 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®, Ipsen, Paris, France). If ineffective, an enema could be used.

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

Mean number of bowel movements per week
Patients kept daily diaries about times of bowel movements each day.
Characteristics of bowel movements
Patients kept daily diaries about stool consistency and degree of straining severity during defecation.
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 (PAC-QOL) 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 was 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
August 14, 2015
Last Updated
November 3, 2016
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02526849
Brief Title
Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation
Official Title
A Randomized Controlled Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (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 effect of fecal microbiota transplantation in adults with slow transit constipation.
Detailed Description
Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Constipation frequency appears to augment with increasing age, particularly after 65 years old. Recent evidence in the literature and collected in the investigators' laboratory confirm that constipation can be a consequence of intestinal dysbiosis, with an increase of potentially pathogenic microorganisms and a decrease of potentially beneficial microorganisms. These alterations may affect the motility and metabolic environment of colon, especially the production of short chain fatty acids (SCFAs). A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI) and other extraintestinal conditions (e.g. IBD). Similarly, the investigators suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.

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, Slow Transit Constipation, Randomized Controlled Trial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Fecal microbiota transplantation (FMT)
Arm Type
Experimental
Arm Description
On day 1-6, patients received 100ml fresh FMT by nasointestinal tube, once per day. The nasointestinal tube was placed in the patient's proximal jejunum through endoscopy. Then, donor fecal microbiota was infused within 5 minutes through nasointestinal tube.
Arm Title
Conventional treatment
Arm Type
Experimental
Arm Description
Conventional treatment was taken by both of two groups. 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®, Ipsen, Paris, France). If ineffective, an enema could be used.
Intervention Type
Drug
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional treatment
Intervention Description
Conventional treatment was taken by both of two groups. 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®, Ipsen, Paris, France). If ineffective, an enema could be used.
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
3 months
Secondary Outcome Measure Information:
Title
Mean number of bowel movements per week
Description
Patients kept daily diaries about times of bowel movements each day.
Time Frame
3 months
Title
Characteristics of bowel movements
Description
Patients kept daily diaries about stool consistency and degree of straining severity during defecation.
Time Frame
3 months
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
3 months
Title
Quality-of-Life assessments
Description
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.
Time Frame
3 months
Title
Colonic transit time measurements
Description
Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.
Time Frame
3 months
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 was used. Patients kept daily diaries about the rescue medication when used.
Time Frame
3 months
Title
Adverse events
Description
Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.
Time Frame
3 months

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
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

12. IPD Sharing Statement

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Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation

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