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Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation

Primary Purpose

Slow Transit Constipation

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Freeze-dried, Capsulized FMT

Fresh FMT

About this trial

This is an interventional treatment trial for Slow Transit Constipation focused on measuring Slow Transit Constipation, Freeze-dried, Capsulized FMT, Fresh FMT

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

Arm Label

Freeze-dried, Capsulized FMT

Fresh FMT

Arm Description

Patients included will receive bowel lavage and subsequent Freeze-dried, Capsulized FMT, and then will be followed up for 3 months.

Patients included will receive bowel lavage and subsequent Fresh FMT, and then will be followed up for 3 months.

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

NCT ID

NCT02676388

First Posted

February 3, 2016

Last Updated

March 13, 2016

Sponsor

Jinling Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02676388

Brief Title

Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation

Official Title

Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation: a Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

June 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 compare the effect of freeze-dried, capsulized FMT and fresh FMT 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

Slow Transit Constipation, Freeze-dried, Capsulized FMT, Fresh FMT

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

Freeze-dried, Capsulized FMT

Arm Type

Experimental

Arm Description

Patients included will receive bowel lavage and subsequent Freeze-dried, Capsulized FMT, and then will be followed up for 3 months.

Arm Title

Fresh FMT

Arm Type

Experimental

Arm Description

Patients included will receive bowel lavage and subsequent Fresh FMT, and then will be followed up for 3 months.

Intervention Type

Procedure

Intervention Name(s)

Freeze-dried, Capsulized FMT

Intervention Type

Procedure

Intervention Name(s)

Fresh FMT

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

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

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

jinlingh_gongjf@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ning Li, MD

Phone

+86-25-80860089

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: